Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this clinical trial is to learn about the safety, how well the study medicine works, extent to which side effects can be tolerated, and how the study medicine is changed and eliminated from your body after you apply it on your skin. The study medicine is in ointment form.
This study is seeking participants who
If they have Atopic Dermatitis (AD):
If they have plaque psoriasis (PsO):
All participants in this study will receive either 0.01% PF-07038124, 0.03% PF-07038124, or a vehicle ointment. In addition, some participants with PsO will receive 0.06% PF- PF-07038124. Participants will not know which dose level they have received. The participants will be randomly assigned to each dose group.
PF-07038124 ointment will be applied topically to affected areas once daily. We will compare the experiences of people receiving the different dose levels of the ointment to those who receive the vehicle ointment. This will help us determine if PF-07038124 ointment is safe and effective.
Participants will take part in this study for approximately 21 weeks. Participants will apply the study medicine once daily for 12 weeks followed by a safety follow-up period of 4-5 weeks from last application of study medicine to last visit.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atopic Dermatitis PF-07038124 0.01% ointment | Experimental | Atopic Dermatitis |
|
| Atopic Dermatitis Vehicle ointment | Placebo Comparator | Atopic Dermatitis |
|
| Atopic Dermatitis PF-07038124 0.03% ointment | Experimental | Atopic Dermatitis |
|
| Plaque Psoriasis PF-07038124 0.01% ointment | Experimental | Plaque Psoriasis |
|
| Plaque Psoriasis PF-07038124 0.03% ointment | Experimental | Plaque Psoriasis |
|
| Plaque Psoriasis PF-07038124 0.06% ointment | Experimental | Plaque Psoriasis |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-07038124 ointment 0.01% | Drug | Atopic Dermatitis and Plaque Psoriasis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Investigator's Global Assessment (IGA) Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of More Than or Equal to (>=) 2 Points at Week 12: Participants With Atopic Dermatitis (AD) Only | IGA assessed severity of AD on 5-point scale ranging from 0(clear)to 4(severe)higher scores indicate more severity,reflecting a global consideration of erythema (ery),induration and scaling. Clinical evaluator assessed overall severity of AD and assigned IGA score as follows: 0 (clear) no inflammatory signs of AD; 1=almost clear, AD not fully cleared-light pink residual lesions(except post-inflammatory hyperpigmentation),just perceptible ery, papulation/induration lichenification, excoriation, no oozing/crusting; 2=mild AD with light red lesions, slight but definite ery, papulation/induration, lichenification, excoriation, no oozing/crusting; 3=moderate AD with red lesions, moderate ery, papulation/induration, lichenification, excoriation, slight oozing/crusting; 4=severe AD with deep dark red lesions, severe ery, papulation/induration, lichenification, excoriation, moderate to severe oozing/crusting.95 percentage (%)confidence interval was based on Blyth-Still-Casella method. | Baseline, Week 12 |
| Percentage of Participants With Physician's Global Assessment (PGA) Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of >=2 Points at Week 12: Participants With Plaque Psoriasis Only | The PGA of psoriasis was scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling were scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear). In this OM, percentages of participants with a PGA score of 0 or 1 and an improvement of >=2 from Baseline in PGA score were reported. 95% confidence interval (CI) was based on Blyth-Still-Casella method. | Baseline, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With >= 75% Improvement in Eczema Area and Severity Index Total Score (EASI-75) From Baseline, at Week 1, 2, 4, 6, 8, 10, 12: Participants With Atopic Dermatitis Only | EASI quantified severity of AD based on severity of lesion clinical signs and % of body surface area(BSA)affected.Severity of clinical signs of AD lesions (erythema [E], induration/papulation[I],excoriation[Ex] and lichenification[L]) were scored separately for each of 4 body regions(head and neck, upper limbs, trunk [including axillae and groin)], lower limbs [including buttocks]) on a 4-point scale:0= absent; 1= mild;2= moderate;3= severe.EASI area score was based on % BSA with AD in body region: 0(0%), 1(>0 to <10%),2 (10 to <30%), 3(30 to <50%), 4(50 to <70%), 5(70 to <90%) and 6(90 to 100%).Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu)+0.3*At*(Et+It+Ext+Lt)+0.4*Al*(El+Il+Exl+Ll);A= EASI area score;h= head and neck;u= upper limbs;t= trunk;l= lower limbs.Total EASI score=0.0 to 72.0, higher scores indicate greater severity of AD.EASI 75 response was defined as at least a 75% reduction in EASI relative to Baseline.95% CI was based on Blyth-Still-Casella method. |
Not provided
Inclusion Criteria for AD population:
Inclusion Criteria for Plaque Psoriasis
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Dermatology & Clinical Research Institute | Encinitas | California | 92024 | United States | ||
| USC/Norris Comprehensive Cancer Center |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Not provided
Not provided
Not provided
A total of 263 participants were enrolled and randomized in the study.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Atopic Dermatitis: Vehicle Ointment | Participants with mild or moderate atopic dermatitis applied the vehicle ointment topically on affected areas once daily (QD) for 12 weeks. |
| FG001 | Atopic Dermatitis: PF-07038124 0.01% Ointment |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment (12 Weeks) |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 2, 2022 | Jul 23, 2024 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Plaque Psoriasis Vehicle ointment | Placebo Comparator | Plaque Psoriasis |
|
| Vehicle ointment | Drug | Atopic Dermatitis and Plaque Psoriasis |
|
| PF-07038124 ointment 0.03% | Drug | Atopic Dermatitis and Plaque Psoriasis |
|
| PF-07038124 ointment 0.06% | Drug | PF-07038124 ointment 0.06% (Plaque Psoriasis only) |
|
| Baseline, Week 1, 2, 4, 6, 8, 10 and 12 |
| Percentage of Participants With >=75% Improvement in Psoriasis Area and Severity Index Total Score (PASI-75) From Baseline, at Week 1, 2, 4, 6, 8, 10, 12: Participants With Plaque Psoriasis Only | The PASI quantified the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of BSA" affected. PASI was a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score could vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI score =0.1Ah(Eh+Ih+Sh) + 0.2Au(Eu+Iu+Su) + 0.3At(Et+It+St) + 0.4Al(El+Il+Sl) (A= PASI area score,S=scaling)PASI 75 response was defined as at least a 75 percent (%) reduction in PASI relative to Baseline. 95% confidence interval was based on Blyth-Still-Casella method. | Baseline, Week 1, 2, 4, 6, 8, 10 and 12 |
| Percentage of Participants With IGA Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of >= 2 Points at Weeks 1, 2, 4, 6, 8 and 10: Participants With Atopic Dermatitis Only | IGA assessed severity of AD on 5-point scale ranging from 0(clear)to 4(severe)higher scores indicate more severity,reflecting a global consideration of erythema (ery),induration and scaling. Clinical evaluator assessed overall severity of AD and assigned IGA score as follows: 0 (clear) no inflammatory signs of AD; 1=almost clear, AD not fully cleared-light pink residual lesions(except post-inflammatory hyperpigmentation),just perceptible ery, papulation/induration lichenification, excoriation, no oozing/crusting; 2=mild AD with light red lesions, slight but definite ery, papulation/induration, lichenification, excoriation, no oozing/crusting; 3=moderate AD with red lesions, moderate ery, papulation/induration, lichenification, excoriation, slight oozing/crusting; 4=severe AD with deep dark red lesions, severe ery, papulation/induration, lichenification, excoriation, moderate to severe oozing/crusting.95%confidence interval was based on Blyth-Still-Casella method. | Baseline, Week 1, 2, 4, 6, 8, and 10 |
| Percentage of Participants With PGA Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of >=2 Points at Weeks 1, 2, 4, 6, 8 and 10: Participants With Plaque Psoriasis Only | The PGA of psoriasis was scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling were scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear). In this OM, percentages of participants with a PGA score of 0 or 1 and an improvement of >=2 from Baseline in PGA score were reported. 95% confidence interval was based on Blyth-Still-Casella method. | Baseline, Week 1, 2, 4, 6, 8, and 10 |
| Percentage of Participants With IGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis Only | IGA assessed severity of AD on 5-point scale ranging from 0(clear)to 4(severe)higher scores indicate more severity,reflecting a global consideration of erythema (ery),induration and scaling. Clinical evaluator assessed overall severity of AD and assigned IGA score as follows: 0 (clear) no inflammatory signs of AD; 1=almost clear, AD not fully cleared-light pink residual lesions(except post-inflammatory hyperpigmentation),just perceptible ery, papulation/induration lichenification, excoriation, no oozing/crusting; 2=mild AD with light red lesions, slight but definite ery, papulation/induration, lichenification, excoriation, no oozing/crusting; 3=moderate AD with red lesions, moderate ery, papulation/induration, lichenification, excoriation, slight oozing/crusting; 4=severe AD with deep dark red lesions, severe ery, papulation/induration, lichenification, excoriation, moderate to severe oozing/crusting. 95% confidence interval was based on Blyth-Still-Casella method. | Week 1, 2, 4, 6, 8, 10 and 12 |
| Percentage of Participants With PGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis Only | The PGA of psoriasis was scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling were scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear). 95% confidence interval was based on Blyth-Still-Casella method. | Week 1, 2, 4, 6, 8, 10 and 12 |
| Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis Only | EASI quantified severity of AD based on severity of lesion clinical signs and percentage (%) of body surface area (BSA) affected. Severity of clinical signs of AD lesions (erythema [E], induration/papulation [I], excoriation [Ex] and lichenification [L]) were scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin)] and lower limbs [including buttocks]) on a 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based on % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score=0.0 to 72.0, higher scores indicate greater severity of AD. 95% confidence interval was based on Blyth-Still-Casella method. | Baseline, Week 1, 2, 4, 6, 8, 10 and 12 |
| Change From Baseline in Psoriasis Area and Severity Index (PASI) Total Score at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis Only | The PASI quantified the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of BSA" affected. PASI was a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score could vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI =0.1Ah(Eh+Ih+Sh) + 0.2Au(Eu+Iu+Su) + 0.3At(Et+It+St) + 0.4Al(El+Il+Sl) (A= PASI area score,S=scaling)PASI 75 response was defined as at least a 75 percent (%) reduction in PASI relative to Baseline. 95% confidence interval was based on Blyth-Still-Casella method. | Baseline, Week 1, 2, 4, 6, 8, 10 and 12 |
| Percentage of Participants With >= 4 Points of Reduction From Baseline in Weekly Average of Peak Pruritus Numerical Rating Scale (PP-NRS) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis Only | The PP-NRS was a daily participant reported assessment of intensity of pruritus on an 11-point numerical rating scale ranging from 0 ('No Itch) to 10 ('Worst Itch Imaginable'), with a 24-hour recall period. Participants were asked to assess their itch intensity over the past 24 hours, on a scale from 0 (no itching) to 10 (worst possible itching). Higher scores indicated worse itch. For the PP-NRS score, baseline was defined as the average of all values recorded between Day -7 (7 days prior to dosing) and Day -1 (1 day prior to dosing). In this OM, percentages of AD participants with >=4 points of reduction in weekly averages of PP-NRS from baseline are reported (percentage based on number of participants with baseline >=4). | Baseline, Week 1, 2, 4, 6, 8, 10 and 12 |
| Percentage of Adult (18-75 Years Old) Participants With >=4 Points of Reduction From Baseline in Weekly Average of PP-NRS at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis Only | The PP-NRS was a daily participant reported assessment of intensity of pruritus on an 11-point numerical rating scale ranging from 0 ('No Itch) to 10 ('Worst Itch Imaginable'), with a 24-hour recall period. Participants were asked to assess their itch intensity over the past 24 hours, on a scale from 0 (no itching) to 10 (worst possible itching). Higher scores indicated worse itch. For the PP-NRS score, baseline was defined as the average of all values recorded between Day -7 (7 days prior to dosing) and Day -1 (1 day prior to dosing). In this OM, percentages of plaque psoriasis participants (18-75 years old) with >=4 points of reduction in weekly averages of PP-NRS from baseline are reported (percentage based on number of participants with baseline >=4). | Week 1, 2, 4, 6, 8, 10 and 12 |
| Percent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis and Plaque Psoriasis | Four body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's hand with fingers in a closed position) fitting in the affected area of a body region was estimated. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint was equal to 10% for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region was calculated as = total number of handprints in a body region * % surface area equivalent to 1 handprint. Overall percentage (%) BSA for individuals with AD ranged from 5-40 % BSA and for individuals with Psoriasis ranged from 2-20 % BSA. Higher % BSA = greater area affected. | Baseline, Week 1, 2, 4, 6, 8, 10 and 12 |
| Number of Participants With Treatment Emergent Adverse Events (AEs): Participants With Atopic Dermatitis and Plaque Psoriasis | An AE was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered TEAE if the event occurred on or after the first dosing date but before the last dose plus the lag time (35 days). | From start of study treatment up to 35 days after last dose of treatment (up to 19 weeks) |
| Number of Participants With Serious Adverse Events (SAEs): Participants With Atopic Dermatitis and Plaque Psoriasis | An SAE was any untoward medical occurrence at any dose that resulted in death; was life-threatening; required hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic or other important medical events. | From start of study treatment up to 35 days after last dose of treatment (up to 19 weeks) |
| Number of Participants With Clinically Significant Changes in Vital Signs: Participants With Atopic Dermatitis and Plaque Psoriasis | Temperature, pulse rate, and blood pressure were assessed in vital sign examination. Body temperature was collected using oral, tympanic, axillary or temporal methods. Blood pressure and pulse rate measurements were assessed with the participant in a supine or seated position using a completely automated device after at least 5 minutes of rest for the participant. Clinically significant changes were determined by the investigator. | From start of study treatment (Day 1) up to Week 12 |
| Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG): Participants With Atopic Dermatitis and Plaque Psoriasis | A standard 12-lead ECG utilizing limb leads was collected using ECG machine that automatically calculated the heart rate and measured pulse rate, QT, and QTc intervals and QRS complex. Clinically significant findings (including, but not limited to, changes from baseline in QTcF after enrollment) were determined by the investigator or qualified designee. | From start of study treatment (Day 1) up to Week 12 |
| Number of Participants With Laboratory Abnormalities: Participants With Atopic Dermatitis and Plaque Psoriasis | Laboratory assessments included hematology, clinical chemistry and urinalysis. Clinically significant abnormal laboratory findings were those which were not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. | From start of study treatment (Day 1) up to Week 12 |
| Number of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque Psoriasis | The investigator or designee assessed tolerability at the site of study intervention application, immediately post-application of the study intervention. Skin Tolerability Grading System for non-lesional skin included grade 0 (No evidence of local intolerance), grade 1 (Mild-Minimal erythema and/or edema, slight glazed appearance), grade 2 (Moderate-Definite erythema and/or edema with peeling and/or cracking but needs no adaptation of posology), grade 3 (Severe-Erythema, edema glazing with fissures, few vesicles or papules: consider removing topical agent [if still in place], grade 4 (very severe- Strong reaction spreading beyond the treated area, bullous reaction, erosions: removal of topical agent [if still in place]. | From start of study treatment (Day 1) up to Week 12 |
| Los Angeles |
| California |
| 90033 |
| United States |
| Renaissance Research and Medical Group | Cape Coral | Florida | 33991 | United States |
| Clinical Neuroscience Solutions, Inc. dba CNS Healthcare | Jacksonville | Florida | 32256 | United States |
| ForCare Clinical Research | Tampa | Florida | 33613 | United States |
| Skin Care Physicians of Georgia | Macon | Georgia | 31217 | United States |
| Sneeze, Wheeze & Itch Associates, LLC | Normal | Illinois | 61761 | United States |
| Dawes Fretzin Clinical Research Group, LLC | Indianapolis | Indiana | 46250 | United States |
| Velocity Clinical Research at The Dermatology Clinic, Baton Rouge | Baton Rouge | Louisiana | 70808 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Wayne Health | Dearborn | Michigan | 48124 | United States |
| Northwell Health Clinical Trials Office | Lake Success | New York | 11042 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10028 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| Vital Prospects Clinical Research Institute, PC | Tulsa | Oklahoma | 74136 | United States |
| Velocity Clinical Research, Medford | Medford | Oregon | 97504 | United States |
| Health Concepts | Rapid City | South Dakota | 57702 | United States |
| Clinical Neuroscience Solutions Inc. | Memphis | Tennessee | 38119 | United States |
| Clinical Neuroscience Solutions, Inc. dba CNS Healthcare | Memphis | Tennessee | 38119 | United States |
| Dermatology Treatment and Research Center | Dallas | Texas | 75230 | United States |
| Progressive Clinical Research | San Antonio | Texas | 78213 | United States |
| Texas Dermatology and Laser Specialists | San Antonio | Texas | 78218 | United States |
| Virginia Clinical Research, Inc. | Norfolk | Virginia | 23502 | United States |
| Dermatology Research Institute | Calgary | Alberta | T2J 7E1 | Canada |
| Wiseman Dermatology Research Inc. | Winnipeg | Manitoba | R3M 3Z4 | Canada |
| Lynderm Research Inc. | Markham | Ontario | L3P 1X3 | Canada |
| DermEdge Research | Mississauga | Ontario | L4Y 4C5 | Canada |
| DermEdge Research | Mississauga | Ontario | L5H 1G9 | Canada |
| SKiN Centre for Dermatology | Peterborough | Ontario | K9J 5K2 | Canada |
| Innovaderm Research Inc. | Montreal | Quebec | H2X 2V1 | Canada |
| Centre de Recherche Dermatologique du Quebec metropolitain | Québec | G1V 4X7 | Canada |
| Takagi Dermatological Clinic Branch | Obihiro | Hokkaido | 080-0013 | Japan |
| Takagi Dermatology | Obihiro | Hokkaido | 080-0013 | Japan |
| Dermatology Shimizu Clinic | Kobe | Hyōgo | 657-0846 | Japan |
| Dermatology and Ophthalmology Kume Clinic | Sakai | Osaka | 593-8324 | Japan |
| Shirasaki dermatology clinic | Takaoka | Toyama | 933-0871 | Japan |
| Egin Research High Wycombe | High Wycombe | Buckinghamshire | HP11 2QW | United Kingdom |
| Southampton General Hospital | Southampton | Hampshire | SO16 6YD | United Kingdom |
| Accellacare - North London | Northwood | London, CITY of | HA6 2RN | United Kingdom |
Participants with mild or moderate atopic dermatitis applied PF-07038124 0.01% ointment topically on affected areas QD for 12 weeks.
| FG002 | Atopic Dermatitis: PF-07038124 0.03% Ointment | Participants with mild or moderate atopic dermatitis applied PF-07038124 0.03% ointment topically on affected areas QD for 12 weeks. |
| FG003 | Psoriasis: PF-07038124 Vehicle Ointment | Participants with mild, moderate, or severe psoriasis applied PF-07038124 0% ointment topically on affected areas QD for 12 weeks. |
| FG004 | Psoriasis: PF-07038124 0.01% Ointment | Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.01% ointment topically on affected areas QD for 12 weeks. |
| FG005 | Psoriasis: PF-07038124 0.03% Ointment | Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.03% ointment topically on affected areas QD for 12 weeks. |
| FG006 | Psoriasis: PF-07038124 0.06% Ointment | Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.06% ointment topically on affected areas QD for 12 weeks. |
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Follow-up (up to 5 Weeks) |
|
|
Safety analysis set included all participants randomly assigned to study intervention who received at least 1 dose of study intervention.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Atopic Dermatitis: Vehicle Ointment | Participants with mild or moderate atopic dermatitis applied the vehicle ointment topically on affected areas once daily (QD) for 12 weeks. |
| BG001 | Atopic Dermatitis: PF-07038124 0.01% Ointment | Participants with mild or moderate atopic dermatitis applied PF-07038124 0.01% ointment topically on affected areas QD for 12 weeks. |
| BG002 | Atopic Dermatitis: PF-07038124 0.03% Ointment | Participants with mild or moderate atopic dermatitis applied PF-07038124 0.03% ointment topically on affected areas QD for 12 weeks. |
| BG003 | Psoriasis: PF-07038124 Vehicle Ointment | Participants with mild, moderate, or severe psoriasis applied PF-07038124 0% ointment topically on affected areas QD for 12 weeks. |
| BG004 | Psoriasis: PF-07038124 0.01% Ointment | Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.01% ointment topically on affected areas QD for 12 weeks. |
| BG005 | Psoriasis: PF-07038124 0.03% Ointment | Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.03% ointment topically on affected areas QD for 12 weeks. |
| BG006 | Psoriasis: PF-07038124 0.06% Ointment | Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.06% ointment topically on affected areas QD for 12 weeks. |
| BG007 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Investigator's Global Assessment (IGA) Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of More Than or Equal to (>=) 2 Points at Week 12: Participants With Atopic Dermatitis (AD) Only | IGA assessed severity of AD on 5-point scale ranging from 0(clear)to 4(severe)higher scores indicate more severity,reflecting a global consideration of erythema (ery),induration and scaling. Clinical evaluator assessed overall severity of AD and assigned IGA score as follows: 0 (clear) no inflammatory signs of AD; 1=almost clear, AD not fully cleared-light pink residual lesions(except post-inflammatory hyperpigmentation),just perceptible ery, papulation/induration lichenification, excoriation, no oozing/crusting; 2=mild AD with light red lesions, slight but definite ery, papulation/induration, lichenification, excoriation, no oozing/crusting; 3=moderate AD with red lesions, moderate ery, papulation/induration, lichenification, excoriation, slight oozing/crusting; 4=severe AD with deep dark red lesions, severe ery, papulation/induration, lichenification, excoriation, moderate to severe oozing/crusting.95 percentage (%)confidence interval was based on Blyth-Still-Casella method. | Intent-to-treat (ITT) analysis set included all participants randomly assigned to study intervention. For this outcome measure (OM), data collection was not planned for the 4 arms of Psoriasis Vehicle QD, Psoriasis PF-07038124 0.01% QD, Psoriasis PF-07038124 0.03% and Psoriasis PF-07038124 0.06% ointment. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline, Week 12 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Physician's Global Assessment (PGA) Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of >=2 Points at Week 12: Participants With Plaque Psoriasis Only | The PGA of psoriasis was scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling were scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear). In this OM, percentages of participants with a PGA score of 0 or 1 and an improvement of >=2 from Baseline in PGA score were reported. 95% confidence interval (CI) was based on Blyth-Still-Casella method. | ITT analysis set included all participants randomly assigned to study intervention. For this OM, data collection was not planned for the 3 arms of AD Vehicle QD, AD PF-07038124 0.01% QD and AD PF-07038124 0.03% QD. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline, Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With >= 75% Improvement in Eczema Area and Severity Index Total Score (EASI-75) From Baseline, at Week 1, 2, 4, 6, 8, 10, 12: Participants With Atopic Dermatitis Only | EASI quantified severity of AD based on severity of lesion clinical signs and % of body surface area(BSA)affected.Severity of clinical signs of AD lesions (erythema [E], induration/papulation[I],excoriation[Ex] and lichenification[L]) were scored separately for each of 4 body regions(head and neck, upper limbs, trunk [including axillae and groin)], lower limbs [including buttocks]) on a 4-point scale:0= absent; 1= mild;2= moderate;3= severe.EASI area score was based on % BSA with AD in body region: 0(0%), 1(>0 to <10%),2 (10 to <30%), 3(30 to <50%), 4(50 to <70%), 5(70 to <90%) and 6(90 to 100%).Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu)+0.3*At*(Et+It+Ext+Lt)+0.4*Al*(El+Il+Exl+Ll);A= EASI area score;h= head and neck;u= upper limbs;t= trunk;l= lower limbs.Total EASI score=0.0 to 72.0, higher scores indicate greater severity of AD.EASI 75 response was defined as at least a 75% reduction in EASI relative to Baseline.95% CI was based on Blyth-Still-Casella method. | ITT analysis set included all participants randomly assigned to study intervention. For this OM, data collection was not planned for the 4 arms of Psoriasis Vehicle QD, Psoriasis PF-07038124 0.01% QD, Psoriasis PF-07038124 0.03% and Psoriasis PF-07038124 0.06% ointment. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline, Week 1, 2, 4, 6, 8, 10 and 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With >=75% Improvement in Psoriasis Area and Severity Index Total Score (PASI-75) From Baseline, at Week 1, 2, 4, 6, 8, 10, 12: Participants With Plaque Psoriasis Only | The PASI quantified the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of BSA" affected. PASI was a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score could vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI score =0.1Ah(Eh+Ih+Sh) + 0.2Au(Eu+Iu+Su) + 0.3At(Et+It+St) + 0.4Al(El+Il+Sl) (A= PASI area score,S=scaling)PASI 75 response was defined as at least a 75 percent (%) reduction in PASI relative to Baseline. 95% confidence interval was based on Blyth-Still-Casella method. | ITT analysis set included all participants randomly assigned to study intervention. For this OM, data collection was not planned for the 3 arms of AD Vehicle QD, AD PF-07038124 0.01% QD and AD PF-07038124 0.03% QD. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline, Week 1, 2, 4, 6, 8, 10 and 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With IGA Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of >= 2 Points at Weeks 1, 2, 4, 6, 8 and 10: Participants With Atopic Dermatitis Only | IGA assessed severity of AD on 5-point scale ranging from 0(clear)to 4(severe)higher scores indicate more severity,reflecting a global consideration of erythema (ery),induration and scaling. Clinical evaluator assessed overall severity of AD and assigned IGA score as follows: 0 (clear) no inflammatory signs of AD; 1=almost clear, AD not fully cleared-light pink residual lesions(except post-inflammatory hyperpigmentation),just perceptible ery, papulation/induration lichenification, excoriation, no oozing/crusting; 2=mild AD with light red lesions, slight but definite ery, papulation/induration, lichenification, excoriation, no oozing/crusting; 3=moderate AD with red lesions, moderate ery, papulation/induration, lichenification, excoriation, slight oozing/crusting; 4=severe AD with deep dark red lesions, severe ery, papulation/induration, lichenification, excoriation, moderate to severe oozing/crusting.95%confidence interval was based on Blyth-Still-Casella method. | ITT analysis set included all participants randomly assigned to study intervention. For this outcome measure (OM), data collection was not planned for the 4 arms of Psoriasis Vehicle QD, Psoriasis PF-07038124 0.01% QD, Psoriasis PF-07038124 0.03% and Psoriasis PF-07038124 0.06% ointment. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline, Week 1, 2, 4, 6, 8, and 10 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With PGA Score of Clear (0) or Almost Clear (1) and a Reduction From Baseline of >=2 Points at Weeks 1, 2, 4, 6, 8 and 10: Participants With Plaque Psoriasis Only | The PGA of psoriasis was scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling were scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear). In this OM, percentages of participants with a PGA score of 0 or 1 and an improvement of >=2 from Baseline in PGA score were reported. 95% confidence interval was based on Blyth-Still-Casella method. | ITT analysis set included all participants randomly assigned to study intervention. For this OM, data collection was not planned for the 3 arms of AD Vehicle QD, AD PF-07038124 0.01% QD and AD PF-07038124 0.03% QD. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline, Week 1, 2, 4, 6, 8, and 10 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With IGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis Only | IGA assessed severity of AD on 5-point scale ranging from 0(clear)to 4(severe)higher scores indicate more severity,reflecting a global consideration of erythema (ery),induration and scaling. Clinical evaluator assessed overall severity of AD and assigned IGA score as follows: 0 (clear) no inflammatory signs of AD; 1=almost clear, AD not fully cleared-light pink residual lesions(except post-inflammatory hyperpigmentation),just perceptible ery, papulation/induration lichenification, excoriation, no oozing/crusting; 2=mild AD with light red lesions, slight but definite ery, papulation/induration, lichenification, excoriation, no oozing/crusting; 3=moderate AD with red lesions, moderate ery, papulation/induration, lichenification, excoriation, slight oozing/crusting; 4=severe AD with deep dark red lesions, severe ery, papulation/induration, lichenification, excoriation, moderate to severe oozing/crusting. 95% confidence interval was based on Blyth-Still-Casella method. | ITT analysis set included all participants randomly assigned to study intervention. For this outcome measure (OM), data collection was not planned for the 4 arms of Psoriasis Vehicle QD, Psoriasis PF-07038124 0.01% QD, Psoriasis PF-07038124 0.03% and Psoriasis PF-07038124 0.06% ointment. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 1, 2, 4, 6, 8, 10 and 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With PGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis Only | The PGA of psoriasis was scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling were scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear). 95% confidence interval was based on Blyth-Still-Casella method. | ITT analysis set included all participants randomly assigned to study intervention. For this OM, data collection was not planned for the 3 arms of AD Vehicle QD, AD PF-07038124 0.01% QD and AD PF-07038124 0.03% QD. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 1, 2, 4, 6, 8, 10 and 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis Only | EASI quantified severity of AD based on severity of lesion clinical signs and percentage (%) of body surface area (BSA) affected. Severity of clinical signs of AD lesions (erythema [E], induration/papulation [I], excoriation [Ex] and lichenification [L]) were scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin)] and lower limbs [including buttocks]) on a 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based on % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score=0.0 to 72.0, higher scores indicate greater severity of AD. 95% confidence interval was based on Blyth-Still-Casella method. | ITT analysis set included all participants randomly assigned to study intervention. Here, 'Number Analyzed' signifies participants evaluable for the specified rows. For this OM, data collection was not planned for the 4 arms of Psoriasis Vehicle QD, Psoriasis PF-07038124 0.01% QD, Psoriasis PF-07038124 0.03% and Psoriasis PF-07038124 0.06% ointment. | Posted | Mean | Standard Deviation | Percent change | Baseline, Week 1, 2, 4, 6, 8, 10 and 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Psoriasis Area and Severity Index (PASI) Total Score at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis Only | The PASI quantified the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of BSA" affected. PASI was a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score could vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI =0.1Ah(Eh+Ih+Sh) + 0.2Au(Eu+Iu+Su) + 0.3At(Et+It+St) + 0.4Al(El+Il+Sl) (A= PASI area score,S=scaling)PASI 75 response was defined as at least a 75 percent (%) reduction in PASI relative to Baseline. 95% confidence interval was based on Blyth-Still-Casella method. | ITT analysis set included all participants randomly assigned to study intervention. All participants reported under 'Number of Participants Analyzed' contributed data to the table; however, may not have evaluable data for every row. Here, 'Number Analyzed' signifies participants evaluable for the specified rows. For this OM, data collection was not planned for the 3 arms of AD Vehicle QD, AD PF-07038124 0.01% QD and AD PF-07038124 0.03% QD. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Week 1, 2, 4, 6, 8, 10 and 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With >= 4 Points of Reduction From Baseline in Weekly Average of Peak Pruritus Numerical Rating Scale (PP-NRS) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis Only | The PP-NRS was a daily participant reported assessment of intensity of pruritus on an 11-point numerical rating scale ranging from 0 ('No Itch) to 10 ('Worst Itch Imaginable'), with a 24-hour recall period. Participants were asked to assess their itch intensity over the past 24 hours, on a scale from 0 (no itching) to 10 (worst possible itching). Higher scores indicated worse itch. For the PP-NRS score, baseline was defined as the average of all values recorded between Day -7 (7 days prior to dosing) and Day -1 (1 day prior to dosing). In this OM, percentages of AD participants with >=4 points of reduction in weekly averages of PP-NRS from baseline are reported (percentage based on number of participants with baseline >=4). | ITT analysis set included all participants randomly assigned to study intervention. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. For this outcome measure (OM), data collection was not planned for the 4 arms of Psoriasis Vehicle QD, Psoriasis PF-07038124 0.01% QD, Psoriasis PF-07038124 0.03% and Psoriasis PF-07038124 0.06% ointment. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline, Week 1, 2, 4, 6, 8, 10 and 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Adult (18-75 Years Old) Participants With >=4 Points of Reduction From Baseline in Weekly Average of PP-NRS at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Plaque Psoriasis Only | The PP-NRS was a daily participant reported assessment of intensity of pruritus on an 11-point numerical rating scale ranging from 0 ('No Itch) to 10 ('Worst Itch Imaginable'), with a 24-hour recall period. Participants were asked to assess their itch intensity over the past 24 hours, on a scale from 0 (no itching) to 10 (worst possible itching). Higher scores indicated worse itch. For the PP-NRS score, baseline was defined as the average of all values recorded between Day -7 (7 days prior to dosing) and Day -1 (1 day prior to dosing). In this OM, percentages of plaque psoriasis participants (18-75 years old) with >=4 points of reduction in weekly averages of PP-NRS from baseline are reported (percentage based on number of participants with baseline >=4). | ITT analysis set included all participants randomly assigned to study intervention.Here,'Overall Number of Participants Analyzed'=participants evaluable for this OM,all participants reported under'Overall Number of Participants Analyzed'contributed data to table but may not have evaluable data for every row.Here,'Number Analyzed'=participants evaluable for specified rows.For this OM,data collection was not planned for 3 arms:AD Vehicle QD, PF-07038124 0.01% QD,AD PF-07038124 0.03% QD ointment. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 1, 2, 4, 6, 8, 10 and 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 4, 6, 8, 10 and 12: Participants With Atopic Dermatitis and Plaque Psoriasis | Four body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's hand with fingers in a closed position) fitting in the affected area of a body region was estimated. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint was equal to 10% for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region was calculated as = total number of handprints in a body region * % surface area equivalent to 1 handprint. Overall percentage (%) BSA for individuals with AD ranged from 5-40 % BSA and for individuals with Psoriasis ranged from 2-20 % BSA. Higher % BSA = greater area affected. | ITT analysis set included all participants randomly assigned to study intervention. All participants reported under 'Number of Participants Analyzed' contributed data to the table; however, may not have evaluable data for every row. Here, 'Number Analyzed' signifies participants evaluable for the specified timepoints. | Posted | Mean | Standard Deviation | Percent change | Baseline, Week 1, 2, 4, 6, 8, 10 and 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment Emergent Adverse Events (AEs): Participants With Atopic Dermatitis and Plaque Psoriasis | An AE was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered TEAE if the event occurred on or after the first dosing date but before the last dose plus the lag time (35 days). | Safety analysis set included all participants randomly assigned to study intervention who received at least 1 dose of study intervention. | Posted | Count of Participants | Participants | From start of study treatment up to 35 days after last dose of treatment (up to 19 weeks) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Serious Adverse Events (SAEs): Participants With Atopic Dermatitis and Plaque Psoriasis | An SAE was any untoward medical occurrence at any dose that resulted in death; was life-threatening; required hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic or other important medical events. | Safety analysis set included all participants randomly assigned to study intervention who received at least 1 dose of study intervention. | Posted | Count of Participants | Participants | From start of study treatment up to 35 days after last dose of treatment (up to 19 weeks) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinically Significant Changes in Vital Signs: Participants With Atopic Dermatitis and Plaque Psoriasis | Temperature, pulse rate, and blood pressure were assessed in vital sign examination. Body temperature was collected using oral, tympanic, axillary or temporal methods. Blood pressure and pulse rate measurements were assessed with the participant in a supine or seated position using a completely automated device after at least 5 minutes of rest for the participant. Clinically significant changes were determined by the investigator. | Safety analysis set included all participants randomly assigned to study intervention who received at least 1 dose of study intervention. | Posted | Count of Participants | Participants | From start of study treatment (Day 1) up to Week 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG): Participants With Atopic Dermatitis and Plaque Psoriasis | A standard 12-lead ECG utilizing limb leads was collected using ECG machine that automatically calculated the heart rate and measured pulse rate, QT, and QTc intervals and QRS complex. Clinically significant findings (including, but not limited to, changes from baseline in QTcF after enrollment) were determined by the investigator or qualified designee. | Safety analysis set included all participants randomly assigned to study intervention who received at least 1 dose of study intervention. | Posted | Count of Participants | Participants | From start of study treatment (Day 1) up to Week 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Laboratory Abnormalities: Participants With Atopic Dermatitis and Plaque Psoriasis | Laboratory assessments included hematology, clinical chemistry and urinalysis. Clinically significant abnormal laboratory findings were those which were not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. | Safety analysis set included all participants randomly assigned to study intervention who received at least 1 dose of study intervention. | Posted | Count of Participants | Participants | From start of study treatment (Day 1) up to Week 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants According to Worst Severity Grades in Local Skin Tolerability: Participants With Atopic Dermatitis and Plaque Psoriasis | The investigator or designee assessed tolerability at the site of study intervention application, immediately post-application of the study intervention. Skin Tolerability Grading System for non-lesional skin included grade 0 (No evidence of local intolerance), grade 1 (Mild-Minimal erythema and/or edema, slight glazed appearance), grade 2 (Moderate-Definite erythema and/or edema with peeling and/or cracking but needs no adaptation of posology), grade 3 (Severe-Erythema, edema glazing with fissures, few vesicles or papules: consider removing topical agent [if still in place], grade 4 (very severe- Strong reaction spreading beyond the treated area, bullous reaction, erosions: removal of topical agent [if still in place]. | Safety analysis set included all participants randomly assigned to study intervention who received at least 1 dose of study intervention. | Posted | Count of Participants | Participants | From start of study treatment (Day 1) up to Week 12 |
|
From start of study treatment up to 35 days after last dose of treatment (up to 19 weeks)
The same event may appear as both an AE and an SAE. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Atopic Dermatitis: Vehicle Ointment | Participants with mild or moderate atopic dermatitis applied the vehicle ointment topically on affected areas once daily (QD) for 12 weeks. | 0 | 44 | 0 | 44 | 0 | 44 |
| EG001 | Atopic Dermatitis: PF-07038124 0.01% Ointment | Participants with mild or moderate atopic dermatitis applied PF-07038124 0.01% ointment topically on affected areas QD for 12 weeks. | 0 | 42 | 1 | 42 | 5 | 42 |
| EG002 | Atopic Dermatitis: PF-07038124 0.03% Ointment | Participants with mild or moderate atopic dermatitis applied PF-07038124 0.03% ointment topically on affected areas QD for 12 weeks. | 0 | 42 | 1 | 42 | 2 | 42 |
| EG003 | Psoriasis: PF-07038124 Vehicle Ointment | Participants with mild, moderate, or severe psoriasis applied PF-07038124 0% ointment topically on affected areas QD for 12 weeks. | 0 | 34 | 0 | 34 | 1 | 34 |
| EG004 | Psoriasis: PF-07038124 0.01% Ointment | Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.01% ointment topically on affected areas QD for 12 weeks. | 0 | 33 | 0 | 33 | 5 | 33 |
| EG005 | Psoriasis: PF-07038124 0.03% Ointment | Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.03% ointment topically on affected areas QD for 12 weeks. | 0 | 35 | 0 | 35 | 2 | 35 |
| EG006 | Psoriasis: PF-07038124 0.06% Ointment | Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.06% ointment topically on affected areas QD for 12 weeks. | 0 | 33 | 1 | 33 | 7 | 33 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pancreatic mass | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Mental disorder | Psychiatric disorders | MedDRA v26.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquires@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 18, 2023 | Jul 23, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D004485 | Eczema |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
| Withdrawal by Subject |
|
| Other |
|
| Physician's decision |
|
| Lost to Follow-up |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Risk Difference (RD) |
| 10.1 |
| 2-Sided |
| 95 |
| -6.1 |
| 26.8 |
| Other |
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.01% ointment topically on affected areas QD for 12 weeks. |
| OG002 | Psoriasis: PF-07038124 0.03% Ointment | Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.03% ointment topically on affected areas QD for 12 weeks. |
| OG003 | Psoriasis: PF-07038124 0.06% Ointment | Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.06% ointment topically on affected areas QD for 12 weeks. |
|
|
|
| OG001 | Atopic Dermatitis: PF-07038124 0.01% Ointment | Participants with mild or moderate atopic dermatitis applied PF-07038124 0.01% ointment topically on affected areas QD for 12 weeks. |
| OG002 | Atopic Dermatitis: PF-07038124 0.03% Ointment | Participants with mild or moderate atopic dermatitis applied PF-07038124 0.03% ointment topically on affected areas QD for 12 weeks. |
|
|
|
| OG001 |
| Psoriasis: PF-07038124 0.01% Ointment |
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.01% ointment topically on affected areas QD for 12 weeks. |
| OG002 | Psoriasis: PF-07038124 0.03% Ointment | Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.03% ointment topically on affected areas QD for 12 weeks. |
| OG003 | Psoriasis: PF-07038124 0.06% Ointment | Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.06% ointment topically on affected areas QD for 12 weeks. |
|
|
|
| OG001 | Atopic Dermatitis: PF-07038124 0.01% Ointment | Participants with mild or moderate atopic dermatitis applied PF-07038124 0.01% ointment topically on affected areas QD for 12 weeks. |
| OG002 | Atopic Dermatitis: PF-07038124 0.03% Ointment | Participants with mild or moderate atopic dermatitis applied PF-07038124 0.03% ointment topically on affected areas QD for 12 weeks. |
|
|
|
Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.01% ointment topically on affected areas QD for 12 weeks. |
| OG002 | Psoriasis: PF-07038124 0.03% Ointment | Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.03% ointment topically on affected areas QD for 12 weeks. |
| OG003 | Psoriasis: PF-07038124 0.06% Ointment | Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.06% ointment topically on affected areas QD for 12 weeks. |
|
|
|
| OG001 | Atopic Dermatitis: PF-07038124 0.01% Ointment | Participants with mild or moderate atopic dermatitis applied PF-07038124 0.01% ointment topically on affected areas QD for 12 weeks. |
| OG002 | Atopic Dermatitis: PF-07038124 0.03% Ointment | Participants with mild or moderate atopic dermatitis applied PF-07038124 0.03% ointment topically on affected areas QD for 12 weeks. |
|
|
|
| OG002 | Psoriasis: PF-07038124 0.03% Ointment | Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.03% ointment topically on affected areas QD for 12 weeks. |
| OG003 | Psoriasis: PF-07038124 0.06% Ointment | Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.06% ointment topically on affected areas QD for 12 weeks. |
|
|
|
| OG001 | Atopic Dermatitis: PF-07038124 0.01% Ointment | Participants with mild or moderate atopic dermatitis applied PF-07038124 0.01% ointment topically on affected areas QD for 12 weeks. |
| OG002 | Atopic Dermatitis: PF-07038124 0.03% Ointment | Participants with mild or moderate atopic dermatitis applied PF-07038124 0.03% ointment topically on affected areas QD for 12 weeks. |
|
|
| OG001 | Psoriasis: PF-07038124 0.01% Ointment | Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.01% ointment topically on affected areas QD for 12 weeks. |
| OG002 | Psoriasis: PF-07038124 0.03% Ointment | Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.03% ointment topically on affected areas QD for 12 weeks. |
| OG003 | Psoriasis: PF-07038124 0.06% Ointment | Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.06% ointment topically on affected areas QD for 12 weeks. |
|
|
| OG001 | Atopic Dermatitis: PF-07038124 0.01% Ointment | Participants with mild or moderate atopic dermatitis applied PF-07038124 0.01% ointment topically on affected areas QD for 12 weeks. |
| OG002 | Atopic Dermatitis: PF-07038124 0.03% Ointment | Participants with mild or moderate atopic dermatitis applied PF-07038124 0.03% ointment topically on affected areas QD for 12 weeks. |
|
|
|
| OG001 | Psoriasis: PF-07038124 0.01% Ointment | Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.01% ointment topically on affected areas QD for 12 weeks. |
| OG002 | Psoriasis: PF-07038124 0.03% Ointment | Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.03% ointment topically on affected areas QD for 12 weeks. |
| OG003 | Psoriasis: PF-07038124 0.06% Ointment | Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.06% ointment topically on affected areas QD for 12 weeks. |
|
|
|
| OG001 | Atopic Dermatitis: PF-07038124 0.01% Ointment | Participants with mild or moderate atopic dermatitis applied PF-07038124 0.01% ointment topically on affected areas QD for 12 weeks. |
| OG002 | Atopic Dermatitis: PF-07038124 0.03% Ointment | Participants with mild or moderate atopic dermatitis applied PF-07038124 0.03% ointment topically on affected areas QD for 12 weeks. |
| OG003 | Psoriasis: PF-07038124 Vehicle Ointment | Participants with mild, moderate, or severe psoriasis applied PF-07038124 0% ointment topically on affected areas QD for 12 weeks. |
| OG004 | Psoriasis: PF-07038124 0.01% Ointment | Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.01% ointment topically on affected areas QD for 12 weeks. |
| OG005 | Psoriasis: PF-07038124 0.03% Ointment | Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.03% ointment topically on affected areas QD for 12 weeks. |
| OG006 | Psoriasis: PF-07038124 0.06% Ointment | Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.06% ointment topically on affected areas QD for 12 weeks. |
|
|
| OG003 | Psoriasis: PF-07038124 Vehicle Ointment | Participants with mild, moderate, or severe psoriasis applied PF-07038124 0% ointment topically on affected areas QD for 12 weeks. |
| OG004 | Psoriasis: PF-07038124 0.01% Ointment | Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.01% ointment topically on affected areas QD for 12 weeks. |
| OG005 | Psoriasis: PF-07038124 0.03% Ointment | Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.03% ointment topically on affected areas QD for 12 weeks. |
| OG006 | Psoriasis: PF-07038124 0.06% Ointment | Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.06% ointment topically on affected areas QD for 12 weeks. |
|
|
Participants with mild or moderate atopic dermatitis applied PF-07038124 0.03% ointment topically on affected areas QD for 12 weeks. |
| OG003 | Psoriasis: PF-07038124 Vehicle Ointment | Participants with mild, moderate, or severe psoriasis applied PF-07038124 0% ointment topically on affected areas QD for 12 weeks. |
| OG004 | Psoriasis: PF-07038124 0.01% Ointment | Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.01% ointment topically on affected areas QD for 12 weeks. |
| OG005 | Psoriasis: PF-07038124 0.03% Ointment | Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.03% ointment topically on affected areas QD for 12 weeks. |
| OG006 | Psoriasis: PF-07038124 0.06% Ointment | Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.06% ointment topically on affected areas QD for 12 weeks. |
|
|
Participants with mild or moderate atopic dermatitis applied PF-07038124 0.03% ointment topically on affected areas QD for 12 weeks. |
| OG003 | Psoriasis: PF-07038124 Vehicle Ointment | Participants with mild, moderate, or severe psoriasis applied PF-07038124 0% ointment topically on affected areas QD for 12 weeks. |
| OG004 | Psoriasis: PF-07038124 0.01% Ointment | Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.01% ointment topically on affected areas QD for 12 weeks. |
| OG005 | Psoriasis: PF-07038124 0.03% Ointment | Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.03% ointment topically on affected areas QD for 12 weeks. |
| OG006 | Psoriasis: PF-07038124 0.06% Ointment | Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.06% ointment topically on affected areas QD for 12 weeks. |
|
|
| OG003 | Psoriasis: PF-07038124 Vehicle Ointment | Participants with mild, moderate, or severe psoriasis applied PF-07038124 0% ointment topically on affected areas QD for 12 weeks. |
| OG004 | Psoriasis: PF-07038124 0.01% Ointment | Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.01% ointment topically on affected areas QD for 12 weeks. |
| OG005 | Psoriasis: PF-07038124 0.03% Ointment | Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.03% ointment topically on affected areas QD for 12 weeks. |
| OG006 | Psoriasis: PF-07038124 0.06% Ointment | Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.06% ointment topically on affected areas QD for 12 weeks. |
|
|
| OG003 | Psoriasis: PF-07038124 Vehicle Ointment | Participants with mild, moderate, or severe psoriasis applied PF-07038124 0% ointment topically on affected areas QD for 12 weeks. |
| OG004 | Psoriasis: PF-07038124 0.01% Ointment | Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.01% ointment topically on affected areas QD for 12 weeks. |
| OG005 | Psoriasis: PF-07038124 0.03% Ointment | Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.03% ointment topically on affected areas QD for 12 weeks. |
| OG006 | Psoriasis: PF-07038124 0.06% Ointment | Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.06% ointment topically on affected areas QD for 12 weeks. |
|
|
| OG002 | Atopic Dermatitis: PF-07038124 0.03% Ointment | Participants with mild or moderate atopic dermatitis applied PF-07038124 0.03% ointment topically on affected areas QD for 12 weeks. |
| OG003 | Psoriasis: PF-07038124 Vehicle Ointment | Participants with mild, moderate, or severe psoriasis applied PF-07038124 0% ointment topically on affected areas QD for 12 weeks. |
| OG004 | Psoriasis: PF-07038124 0.01% Ointment | Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.01% ointment topically on affected areas QD for 12 weeks. |
| OG005 | Psoriasis: PF-07038124 0.03% Ointment | Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.03% ointment topically on affected areas QD for 12 weeks. |
| OG006 | Psoriasis: PF-07038124 0.06% Ointment | Participants with mild, moderate, or severe psoriasis applied PF-07038124 0.06% ointment topically on affected areas QD for 12 weeks. |
|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
|
|
|
|
|
|