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This is a Phase 2a, randomized, double blind, vehicle controlled, parallel group, proof of concept study that will include participants with stasis dermatitis without active skin ulceration, who will receive crisaborole ointment 2% or vehicle twice daily for 6 weeks.
Study C3291038 is a Phase 2a, randomized, double-blind, vehicle-controlled, parallel-group, proof of concept study to evaluate the efficacy, safety, and local tolerability of 6 weeks of treatment with crisaborole in adult participants with SD without active skin ulceration. Approximately 70 eligible participants will be randomized into the double blind treatment period in a 1:1 ratio to receive crisaborole ointment, 2% or vehicle twice daily for 6 weeks.
The study will recruit male and female participants aged ≥ 45 years with a clinical diagnosis of SD.
The total duration of participation in the study will be up to 14 weeks, including up to 4 weeks for screening, a 6 week double blind treatment period, and a follow-up period of 4 weeks after treatment completion.
Study enrollment and management will be de centralized, where participants do not visit an investigator or a clinic for clinical assessment. The participants will participate in the study at home. The sponsor (or designee) will provide home visits by qualified home visit practitioners (HVP), remote contact by telemedicine (or telephone), and clinical database electronic case report forms (eCRFs), eDiary, and other electronic data entries from 3rd party vendors for study data collection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| crisaborole ointment | Experimental | crisaborole ointment |
|
| vehicle ointment | Sham Comparator | vehicle ointment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| crisaborole ointment | Drug | crisaborole ointment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Total Sign Score (TSS) at Week 6: In-person Assessment | TSS assesses severity of stasis dermatitis lesions. There were following 4 clinical signs of all treatable stasis dermatitis lesions: erythema, papulation/elevation, superficial erosion/denudation, and scaling. Each of 4 signs were rated on a scale of 0 to 3 (0= none, 1= mild, 2= moderate, 3= severe). TSS = sum of scores from all clinical signs; ranging from 0 (none) to 12 (most severe), where higher score indicated greater severity. The assessment was completed in person by the home visit practitioner. | Baseline, Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved Treatment Success Based on Investigator's Static Global Assessment (ISGA) at Week 6: In-person Assessment | ISGA is a global assessment of stasis dermatitis lesions severity based on erythema, papulation/elevation, superficial erosion/denudation, and scaling. ISGA excludes scalp from scoring and assessment. ISGA score ranged from 0 to 4; where 0 = clear (minor residual hypo/hyperpigmentation; no erythema or induration/papulation; no oozing/crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration/papulation and no oozing/crusting), 2= mild (faint pink erythema with mild induration/papulation and no oozing/crusting), 3= moderate (pink-red erythema with moderate induration/papulation with or without oozing/crusting), 4= severe (deep or bright red erythema with severe induration/papulation and with oozing/crusting). Higher scores indicated greater severity. The assessment was completed in person by the home visit practitioner. Treatment success was defined as ISGA score of clear/almost clear with at least a 2-grade improvement from baseline. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lightship | El Segundo | California | 90245 | United States | ||
| Hawthorne Effect, Inc |
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Vehicle Ointment | Participants applied vehicle ointment topically twice a day (BID) to the stasis dermatitis affected lower extremities (knees to feet) for 6 weeks. Participants were followed-up for 4 weeks after treatment completion. |
| FG001 | Crisaborole 2% Ointment | Participants applied crisaborole ointment 2 percent (%) topically BID to the stasis dermatitis affected lower extremities (knees to feet) for 6 weeks. Participants were followed-up for 4 weeks after treatment completion. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Full analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention. Participants were analyzed according to the intervention they were randomized.
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| ID | Title | Description |
|---|---|---|
| BG000 | Vehicle Ointment | Participants applied vehicle ointment topically BID to the stasis dermatitis affected lower extremities (knees to feet) for 6 weeks. Participants were followed-up for 4 weeks after treatment completion. |
| BG001 | Crisaborole 2% Ointment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Percent Change From Baseline in Total Sign Score (TSS) at Week 6: In-person Assessment | TSS assesses severity of stasis dermatitis lesions. There were following 4 clinical signs of all treatable stasis dermatitis lesions: erythema, papulation/elevation, superficial erosion/denudation, and scaling. Each of 4 signs were rated on a scale of 0 to 3 (0= none, 1= mild, 2= moderate, 3= severe). TSS = sum of scores from all clinical signs; ranging from 0 (none) to 12 (most severe), where higher score indicated greater severity. The assessment was completed in person by the home visit practitioner. | Full analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention. Participants were analyzed according to the intervention they were randomized. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Least Squares Mean | Standard Error | Percent change | Baseline, Week 6 |
|
Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention and were analyzed according to intervention actually received.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vehicle Ointment | Participants applied vehicle ointment topically BID to the stasis dermatitis affected lower extremities (knees to feet) for 6 weeks. Participants were followed-up for 4 weeks after treatment completion. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Muscular dystrophy | Congenital, familial and genetic disorders | MedDRA v24.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Muscular dystrophy | Congenital, familial and genetic disorders | MedDRA v24.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 19, 2021 | Apr 1, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 16, 2021 | Apr 1, 2022 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D014689 | Venous Insufficiency |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C543085 | crisaborole |
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| vehicle ointment | Other | vehicle ointment |
|
| Week 6 |
| Percentage of Participants Who Achieved Treatment Success Based on Investigator's Static Global Assessment (ISGA) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment | ISGA: global assessment of stasis dermatitis lesions severity based on erythema, papulation/elevation, superficial erosion/denudation, and scaling, excluding scalp. ISGA score ranged from 0 to 4; 0 = clear (minor residual hypo/hyperpigmentation; no erythema or induration/papulation; no oozing/crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration/papulation and no oozing/crusting), 2= mild (faint pink erythema with mild induration/papulation and no oozing/crusting), 3= moderate (pink-red erythema with moderate induration/papulation with or without oozing/crusting), 4= severe (deep or bright red erythema with severe induration/papulation and with oozing/crusting). Higher scores = greater severity. Treatment success: ISGA score of clear/almost clear with at least a 2-grade improvement from baseline. Participants acquired static digital images of the lesions using sponsor-provisioned digital imaging equipment. Images were reviewed by central readers. | Week 1, 2, 3, 4, 5 and 6 |
| Percentage of Participants With an Investigator's Static Global Assessment (ISGA) Score of Clear (0) or Almost Clear (1) at Week 6: In-person Assessment | ISGA is a global assessment of stasis dermatitis lesions severity based on erythema, papulation/elevation, superficial erosion/denudation, and scaling. ISGA excludes scalp from scoring and assessment. ISGA score ranged from 0 to 4; where 0 = clear (minor residual hypo/hyperpigmentation; no erythema or induration/papulation; no oozing/crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration/papulation and no oozing/crusting), 2= mild (faint pink erythema with mild induration/papulation and no oozing/crusting), 3= moderate (pink-red erythema with moderate induration/papulation with or without oozing/crusting), 4= severe (deep or bright red erythema with severe induration/papulation and with oozing/crusting). Higher scores indicated greater severity. The assessment was completed in person by the home visit practitioner. | Week 6 |
| Percentage of Participants With an Investigator's Static Global Assessment (ISGA) Score of Clear (0) or Almost Clear (1) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment | ISGA is a global assessment of stasis dermatitis lesions severity based on erythema, papulation/elevation, superficial erosion/denudation, and scaling. ISGA excludes scalp from scoring and assessment. ISGA score ranged from 0 to 4; where 0 = clear (minor residual hypo/hyperpigmentation; no erythema or induration/papulation; no oozing/crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration/papulation and no oozing/crusting), 2= mild (faint pink erythema with mild induration/papulation and no oozing/crusting), 3= moderate (pink-red erythema with moderate induration/papulation with or without oozing/crusting), 4= severe (deep or bright red erythema with severe induration/papulation and with oozing/crusting). Higher scores indicated greater severity. Participants acquired static digital images of the lesions using sponsor-provisioned digital imaging equipment. Images were reviewed by central readers. | Week 1, 2, 3, 4, 5 and 6 |
| Percent Change From Baseline in Total Sign Score (TSS) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment | TSS assesses severity of stasis dermatitis lesions. There were following 4 clinical signs of all treatable stasis dermatitis lesions: erythema, papulation/elevation, superficial erosion/denudation, and scaling. Each of 4 signs were rated on a scale of 0 to 3 (0= none, 1= mild, 2= moderate, 3= severe). TSS = sum of scores from all clinical signs; ranging from 0 (none) to 12 (most severe), where higher score indicated greater severity. Participants acquired static digital images of the lesions using sponsor-provisioned digital imaging equipment. Images were reviewed by central readers. | Baseline, Week 1, 2, 3, 4, 5 and 6 |
| Percent Change From Baseline in Stasis Dermatitis Lesional Percent Body Surface Area (BSA) at Week 6: In-person Assessment | Stasis dermatitis lesional BSA was calculated using handprint method. Number of handprints (size of participant's full palmer hand) fitting in affected area was counted. One handprint represented approximately 1% of lesional BSA. Percent BSA for a body region = total number of handprints in a body region * % surface area equivalent to 1 handprint. Higher % BSA indicated greater severity. The assessment was completed in person by the home visit practitioner. | Baseline, Week 6 |
| Percent Change From Baseline in Percent Body Surface Area (BSA) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment | Stasis dermatitis lesional BSA was calculated using handprint method. Number of handprints (size of participant's full palmer hand) fitting in affected area was counted. One handprint represented approximately 1% of lesional BSA. Percent BSA for a body region = total number of handprints in a body region * % surface area equivalent to 1 handprint. Higher % BSA indicated greater severity. Participants acquired static digital images of the lesions using sponsor-provisioned digital imaging equipment. Images were reviewed by central readers. | Baseline, Week 1, 2, 3, 4, 5 and 6 |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | An adverse event (AE) was any untoward medical occurrence attributed to a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent were events between first dose of study drug and up to 4 weeks after last dose that were absent before treatment or that worsened relative to pre-treatment state. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; Initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs included both SAEs and all non-SAEs. | Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks) |
| Lafayette |
| California |
| 94549 |
| United States |
| Verily Life Sciences LLC | South San Francisco | California | 94080 | United States |
| Onco360 Oncology Pharmacy | Louisville | Kentucky | 40223 | United States |
| Protocol Violation |
|
| Withdrawal by Subject |
|
Participants applied crisaborole ointment 2% topically BID to the stasis dermatitis affected lower extremities (knees to feet) for 6 weeks. Participants were followed-up for 4 weeks after treatment completion. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Vehicle Ointment |
Participants applied vehicle ointment topically BID to the stasis dermatitis affected lower extremities (knees to feet) for 6 weeks. Participants were followed-up for 4 weeks after treatment completion. |
| OG001 | Crisaborole 2% Ointment | Participants applied crisaborole ointment 2% topically BID to the stasis dermatitis affected lower extremities (knees to feet) for 6 weeks. Participants were followed-up for 4 weeks after treatment completion. |
|
|
|
| Secondary | Percentage of Participants Who Achieved Treatment Success Based on Investigator's Static Global Assessment (ISGA) at Week 6: In-person Assessment | ISGA is a global assessment of stasis dermatitis lesions severity based on erythema, papulation/elevation, superficial erosion/denudation, and scaling. ISGA excludes scalp from scoring and assessment. ISGA score ranged from 0 to 4; where 0 = clear (minor residual hypo/hyperpigmentation; no erythema or induration/papulation; no oozing/crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration/papulation and no oozing/crusting), 2= mild (faint pink erythema with mild induration/papulation and no oozing/crusting), 3= moderate (pink-red erythema with moderate induration/papulation with or without oozing/crusting), 4= severe (deep or bright red erythema with severe induration/papulation and with oozing/crusting). Higher scores indicated greater severity. The assessment was completed in person by the home visit practitioner. Treatment success was defined as ISGA score of clear/almost clear with at least a 2-grade improvement from baseline. | Full analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention. Participants were analyzed according to the intervention they were randomized. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure | Posted | Number | Percentage of participants | Week 6 |
|
|
|
|
| Secondary | Percentage of Participants Who Achieved Treatment Success Based on Investigator's Static Global Assessment (ISGA) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment | ISGA: global assessment of stasis dermatitis lesions severity based on erythema, papulation/elevation, superficial erosion/denudation, and scaling, excluding scalp. ISGA score ranged from 0 to 4; 0 = clear (minor residual hypo/hyperpigmentation; no erythema or induration/papulation; no oozing/crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration/papulation and no oozing/crusting), 2= mild (faint pink erythema with mild induration/papulation and no oozing/crusting), 3= moderate (pink-red erythema with moderate induration/papulation with or without oozing/crusting), 4= severe (deep or bright red erythema with severe induration/papulation and with oozing/crusting). Higher scores = greater severity. Treatment success: ISGA score of clear/almost clear with at least a 2-grade improvement from baseline. Participants acquired static digital images of the lesions using sponsor-provisioned digital imaging equipment. Images were reviewed by central readers. | Full analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention. Participants were analyzed according to the intervention they were randomized. | Posted | Number | Percentage of participants | Week 1, 2, 3, 4, 5 and 6 |
|
|
|
|
| Secondary | Percentage of Participants With an Investigator's Static Global Assessment (ISGA) Score of Clear (0) or Almost Clear (1) at Week 6: In-person Assessment | ISGA is a global assessment of stasis dermatitis lesions severity based on erythema, papulation/elevation, superficial erosion/denudation, and scaling. ISGA excludes scalp from scoring and assessment. ISGA score ranged from 0 to 4; where 0 = clear (minor residual hypo/hyperpigmentation; no erythema or induration/papulation; no oozing/crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration/papulation and no oozing/crusting), 2= mild (faint pink erythema with mild induration/papulation and no oozing/crusting), 3= moderate (pink-red erythema with moderate induration/papulation with or without oozing/crusting), 4= severe (deep or bright red erythema with severe induration/papulation and with oozing/crusting). Higher scores indicated greater severity. The assessment was completed in person by the home visit practitioner. | Full analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention. Participants were analyzed according to the intervention they were randomized. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Number | Percentage of participants | Week 6 |
|
|
|
|
| Secondary | Percentage of Participants With an Investigator's Static Global Assessment (ISGA) Score of Clear (0) or Almost Clear (1) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment | ISGA is a global assessment of stasis dermatitis lesions severity based on erythema, papulation/elevation, superficial erosion/denudation, and scaling. ISGA excludes scalp from scoring and assessment. ISGA score ranged from 0 to 4; where 0 = clear (minor residual hypo/hyperpigmentation; no erythema or induration/papulation; no oozing/crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration/papulation and no oozing/crusting), 2= mild (faint pink erythema with mild induration/papulation and no oozing/crusting), 3= moderate (pink-red erythema with moderate induration/papulation with or without oozing/crusting), 4= severe (deep or bright red erythema with severe induration/papulation and with oozing/crusting). Higher scores indicated greater severity. Participants acquired static digital images of the lesions using sponsor-provisioned digital imaging equipment. Images were reviewed by central readers. | Full analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention. Participants were analyzed according to the intervention they were randomized. | Posted | Number | Percentage of participants | Week 1, 2, 3, 4, 5 and 6 |
|
|
|
|
| Secondary | Percent Change From Baseline in Total Sign Score (TSS) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment | TSS assesses severity of stasis dermatitis lesions. There were following 4 clinical signs of all treatable stasis dermatitis lesions: erythema, papulation/elevation, superficial erosion/denudation, and scaling. Each of 4 signs were rated on a scale of 0 to 3 (0= none, 1= mild, 2= moderate, 3= severe). TSS = sum of scores from all clinical signs; ranging from 0 (none) to 12 (most severe), where higher score indicated greater severity. Participants acquired static digital images of the lesions using sponsor-provisioned digital imaging equipment. Images were reviewed by central readers. | Full analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention. Participants were analyzed according to the intervention they were randomized. Here, "number analyzed" signifies participants evaluable for the specified rows. | Posted | Least Squares Mean | Standard Error | Percent change | Baseline, Week 1, 2, 3, 4, 5 and 6 |
|
|
|
|
| Secondary | Percent Change From Baseline in Stasis Dermatitis Lesional Percent Body Surface Area (BSA) at Week 6: In-person Assessment | Stasis dermatitis lesional BSA was calculated using handprint method. Number of handprints (size of participant's full palmer hand) fitting in affected area was counted. One handprint represented approximately 1% of lesional BSA. Percent BSA for a body region = total number of handprints in a body region * % surface area equivalent to 1 handprint. Higher % BSA indicated greater severity. The assessment was completed in person by the home visit practitioner. | Full analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention. Participants were analyzed according to the intervention they were randomized. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Least Squares Mean | Standard Error | Percent change | Baseline, Week 6 |
|
|
|
|
| Secondary | Percent Change From Baseline in Percent Body Surface Area (BSA) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment | Stasis dermatitis lesional BSA was calculated using handprint method. Number of handprints (size of participant's full palmer hand) fitting in affected area was counted. One handprint represented approximately 1% of lesional BSA. Percent BSA for a body region = total number of handprints in a body region * % surface area equivalent to 1 handprint. Higher % BSA indicated greater severity. Participants acquired static digital images of the lesions using sponsor-provisioned digital imaging equipment. Images were reviewed by central readers. | Full analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention. Participants were analyzed according to the intervention they were randomized. Here, "number analyzed" signifies participants evaluable for the specified rows. | Posted | Least Squares Mean | Standard Error | Percent change | Baseline, Week 1, 2, 3, 4, 5 and 6 |
|
|
|
|
| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | An adverse event (AE) was any untoward medical occurrence attributed to a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent were events between first dose of study drug and up to 4 weeks after last dose that were absent before treatment or that worsened relative to pre-treatment state. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; Initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs included both SAEs and all non-SAEs. | Safety analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention and were analyzed according to intervention actually received. | Posted | Count of Participants | Participants | Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks) |
|
|
|
| 0 |
| 32 |
| 4 |
| 32 |
| 13 |
| 32 |
| EG001 | Crisaborole 2% Ointment | Participants applied crisaborole ointment 2% topically BID to the stasis dermatitis affected lower extremities (knees to feet) for 6 weeks. Participants were followed-up for 4 weeks after treatment completion. | 0 | 33 | 1 | 33 | 13 | 33 |
| Cellulitis | Infections and infestations | MedDRA v24.0 | Non-systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA v24.0 | Non-systematic Assessment |
|
| Oropharyngeal squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v24.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
|
| Food poisoning | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
|
| Oesophageal spasm | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA v24.0 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA v24.0 | Non-systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA v24.0 | Non-systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA v24.0 | Non-systematic Assessment |
|
| Oedema | General disorders | MedDRA v24.0 | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA v24.0 | Non-systematic Assessment |
|
| Peripheral swelling | General disorders | MedDRA v24.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA v24.0 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA v24.0 | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA v24.0 | Non-systematic Assessment |
|
| Conjunctivitis viral | Infections and infestations | MedDRA v24.0 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA v24.0 | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA v24.0 | Non-systematic Assessment |
|
| Tinea pedis | Infections and infestations | MedDRA v24.0 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA v24.0 | Non-systematic Assessment |
|
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA v24.0 | Non-systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA v24.0 | Non-systematic Assessment |
|
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA v24.0 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v24.0 | Non-systematic Assessment |
|
| Burning sensation | Nervous system disorders | MedDRA v24.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA v24.0 | Non-systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA v24.0 | Non-systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA v24.0 | Non-systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA v24.0 | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA v24.0 | Non-systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA v24.0 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v24.0 | Non-systematic Assessment |
|
| Skin erosion | Skin and subcutaneous tissue disorders | MedDRA v24.0 | Non-systematic Assessment |
|
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA v24.0 | Non-systematic Assessment |
|
| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA v24.0 | Non-systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA v24.0 | Non-systematic Assessment |
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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.
| Week 3 |
|
| Week 4 |
|
| Week 5 |
|
| Week 6 |
|
| Normal approximation test |
| 0.4789 |
1-sided |
| Difference in percentage of participants |
| -0.47 |
| 2-Sided |
| 90 |
| -15.20 |
| 14.25 |
| Superiority |
| Week 3 | Normal approximation test | 0.4815 | 1-sided | Difference in percentage of participants | -0.38 | 2-Sided | 90 | -13.79 | 13.03 | Superiority |
| Week 4 | Normal approximation test | 0.4815 | 1-sided | Difference in percentage of participants | -0.38 | 2-Sided | 90 | -13.79 | 13.03 | Superiority |
| Week 5 | Normal approximation test | 0.1197 | 1-sided | Difference in percentage of participants | 8.90 | 2-Sided | 90 | -3.55 | 21.35 | Superiority |
| Week 6 | Normal approximation test | 0.0034 | 1-sided | Difference in percentage of participants | 18.18 | 2-Sided | 90 | 7.14 | 29.23 | Superiority |
| Week 3 |
|
| Week 4 |
|
| Week 5 |
|
| Week 6 |
|
| Normal approximation test |
| 0.0809 |
1-sided |
| Difference in percentage of participants |
| 17.05 |
| 2-Sided |
| 90 |
| -2.99 |
| 37.08 |
| Superiority |
| Week 3 | Normal approximation test | 0.4450 | 1-sided | Difference in percentage of participants | 1.70 | 2-Sided | 90 | -18.58 | 21.99 | Superiority |
| Week 4 | Normal approximation test | 0.4450 | 1-sided | Difference in percentage of participants | 1.70 | 2-Sided | 90 | -18.58 | 21.99 | Superiority |
| Week 5 | Normal approximation test | 0.0385 | 1-sided | Difference in percentage of participants | 20.45 | 2-Sided | 90 | 1.43 | 39.48 | Superiority |
| Week 6 | Normal approximation test | 0.0045 | 1 sided | Difference in percentage of participants | 29.64 | 2-Sided | 90 | 10.95 | 48.33 | Superiority |
| Week 2 |
|
|
| Week 3 |
|
|
| Week 4 |
|
|
| Week 5 |
|
|
| Week 6 |
|
|
| Normal approximation test |
| 0.3506 |
1-sided |
| LS mean Difference |
| -4.47 |
| Standard Error of the Mean |
| 11.59 |
| 2-Sided |
| 90 |
| -23.85 |
| 14.91 |
| Superiority |
| Week 3 | Normal approximation test | 0.2466 | 1-sided | LS mean Difference | 9.81 | Standard Error of the Mean | 14.23 | 2-Sided | 90 | -13.97 | 33.60 | Superiority |
| Week 4 | Normal approximation test | 0.0157 | 1-sided | LS mean Difference | 34.74 | Standard Error of the Mean | 15.74 | 2-Sided | 90 | 8.43 | 61.05 | Superiority |
| Week 5 | Normal approximation test | 0.4548 | 1-sided | LS mean Difference | -1.66 | Standard Error of the Mean | 14.55 | 2-Sided | 90 | -25.99 | 22.68 | Superiority |
| Week 6 | Normal approximation test | 0.0004 | 1-sided | LS mean Difference | -42.19 | Standard Error of the Mean | 11.99 | 2-Sided | 90 | -62.24 | -22.15 | Superiority |
| Week 2 |
|
|
| Week 3 |
|
|
| Week 4 |
|
|
| Week 5 |
|
|
| Week 6 |
|
|
| Normal approximation test |
| 0.2236 |
1-sided |
| LS mean Difference |
| -14.39 |
| Standard Error of the Mean |
| 18.79 |
| 2-Sided |
| 90 |
| -45.81 |
| 17.04 |
| Superiority |
| Week 3 | Normal approximation test | 0.2559 | 1-sided | LS mean Difference | -9.94 | Standard Error of the Mean | 15.05 | 2-Sided | 90 | -35.12 | 15.24 | Superiority |
| Week 4 | Normal approximation test | 0.2392 | 1-sided | LS mean Difference | -16.01 | Standard Error of the Mean | 22.44 | 2-Sided | 90 | -53.54 | 21.52 | Superiority |
| Week 5 | Normal approximation test | 0.2553 | 1-sided | LS mean Difference | -13.01 | Standard Error of the Mean | 19.65 | 2-Sided | 90 | -45.87 | 19.85 | Superiority |
| Week 6 | Normal approximation test | 0.0416 | 1-sided | LS mean Difference | -53.01 | Standard Error of the Mean | 30.05 | 2-Sided | 90 | -103.26 | -2.75 | Superiority |