Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2012-004355-37 | EudraCT Number |
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 study will compare how well PF-06473871 works versus placebo in reducing skin scarring after scar revision surgery of existing breast scars. The study will also evaluate the safety of PF-06473871 in healthy adult subjects.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Active Comparator |
| |
| Group 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-06473871 | Drug | Single dose administered by injection four different times |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Physician Global Assessment Using Physician Overall Opinion Question of Patient and Observer Scar Assessment Scale (POSAS) | Physician global assessment was performed using the overall opinion question of the POSAS scale. Physicians were asked to rate the severity of the participant's scar compared to normal skin. The overall opinion scale score ranged from 1 (normal skin) to 10 (worst imaginable scar). Within participant treatment difference was assessed between the treatment regimens each participant received. | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Physician scar assessment was performed using 10-point POSAS scale. Physician rated each of the items (vascularity, pigmentation, thickness, relief, pliability, surface area and overall opinion) for a scar on a score of 1 (normal skin) to 10 (worst scar imaginable). Within participant treatment difference was assessed between the treatment regimens each participant received. Data for overall opinion scale score at Week 24 was not presented in this outcome measure because the data was reported separately under primary outcome measure 1. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Clinically Significant Vital Sign Abnormalities | Vital Sign included pulse rate, systolic blood pressure, diastolic blood pressure, and weight. | Baseline up to Week 24 |
| Number of Participants With Abnormal Physical Examinations |
Inclusion Criteria:
Exclusion Criteria:
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 |
|---|---|---|---|---|---|---|
| University of California Irvine - Dermatology Research | Irvine | California | 92697 | United States | ||
| Plastic Surgery and Laser Institute of San Diego |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
A total of 103 participants were randomized into the study. Of these, 100 participants received at least 1 dose of study drug and were included in the modified intent to treat (mITT) and safety population.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | PF-06473871/Placebo (4* 5 mg/cm) | Participants with bilateral hypertrophic scars received 4 intradermal injections of PF-06473871 at a dose of 5 milligram per linear centimeter (mg/cm) (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| PF-06473871 |
| Drug |
Single dose administered by injection three different times |
|
| Week 8, 11, 18, 24 |
| Patient Global Assessment Using Overall Opinion of Patient and Observer Scar Assessment Scale (POSAS) | Patient global assessment was performed using the overall opinion question of the POSAS scale. Participants were asked to rate the severity of their scar compared to normal skin. The overall opinion scale score ranged from 1 (normal skin) to 10 (very different from normal skin). Within participant treatment difference was assessed between the treatment regimens each participant received | Week 8, 11, 18, 24 |
| Patient-Reported Scar Evaluation Questionnaire (PR-SEQ) Symptoms and Appearance Domains Score | PR-SEQ questionnaire consisted of 30 different attributes of scars that included following four dimensions: appearance (5 attributes), symptoms (3 attributes), bothersomeness (8 attributes), and impacts on the quality of life (physical and emotional wellbeing [14 attributes]). Each question had 5 possible responses: not at all (0), slightly (1), moderately (2), very (3), and extremely (4). Participants completed an abbreviated version which included only the Symptoms and Appearance dimensions to evaluate treatment outcomes. Each of the item scores were transformed into a 0 to 100 scale. Each dimension score was calculated from averaging the transformed scores (0-100 scaled) for specified items. Each domain score ranged from 0 to 100, with higher scores indicating higher severity. Within participant treatment difference was assessed between the treatment regimens each participant received. | Week 8, 24 |
| Physician and Participant Photoguide Scar Assessment Scale Score | Physician and participants rated severity of each scar using a photonumeric guide on a scale ranging from 1 to 5 (where 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe). Within participant treatment difference was assessed between the treatment regimens each participant received. | Week 8, 11, 18, 24 |
Physical examination included examination of skin, head, eyes, ears, nose, throat (HEENT), respiratory, cardiovascular, abdomen - liver and kidney, musculoskeletal, gastrointestinal, genitourinary, and neurological systems.
| Baseline up to Week 24 |
| Number of Participants With Electrocardiogram Findings | Following parameters were assessed: heart rate, PR Interval, QRS Interval, QT Interval, and Fridericia's Correction Formula (QTcF) interval. Electrocardiogram Results were reported as normal, abnormal, not clinically significant (NCS) and abnormal and clinically significant (CS) as determined by investigator. | Baseline, Week 11 |
| Number of Participants With Treatment Emergent Adverse Events (AEs) of Special Interest | Treatment Emergent Adverse Events (AEs) of special interest included injection site erythema, maculopapular rash, pruritus, bronchospasm, dyspnea, cough, fever and diarrhea. | Baseline up to Week 24 |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Laboratory Abnormalities | An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent adverse event are events between first dose of study drug and up to Week 24 that were absent before treatment or that worsened relative to pre-treatment state. TEAEs related to laboratory abnormalities are reported. | Baseline up to Week 24 |
| La Jolla |
| California |
| 92037 |
| United States |
| Scripps Memorial-Ximed Medical Center | La Jolla | California | 92037 | United States |
| Advanced Cosmetic Surgery Clinic of Walnut Creek | Walnut Creek | California | 94596 | United States |
| Anthony DeMeo, MD | Walnut Creek | California | 94596 | United States |
| Charles Hanson MD | Walnut Creek | California | 94598 | United States |
| PIH Health Plastic Surgery and Aesthetic Medicine | Whittier | California | 90602 | United States |
| PIH health | Whittier | California | 90640 | United States |
| Sanctuary Mediacal Center | Boca Raton | Florida | 33431 | United States |
| Stephan Baker, MD PA | Coral Gables | Florida | 33146 | United States |
| Altus Research | Lake Worth | Florida | 33461 | United States |
| Bayside Ambulatory Center | Miami | Florida | 33133 | United States |
| University of South Florida | Tampa | Florida | 33606 | United States |
| Atlanta APC Plastic Surgery | Atlanta | Georgia | 30308 | United States |
| Kavali Plastic Surgery and Skin Renewal Center | Atlanta | Georgia | 30328 | United States |
| Perimeter Outpatient Surgery Center | Atlanta | Georgia | 30328 | United States |
| Advanced Medical Resarch ,Inc | Atlanta | Georgia | 30342 | United States |
| Atlanta APC Plastic Surgery | Conyers | Georgia | 30012 | United States |
| Spivey Station Surgery Center | Jonesboro | Georgia | 30236 | United States |
| Northwestern University Diagnostic Testing Center | Chicago | Illinois | 60611 | United States |
| Northwestern University,Division of Plastic Surgery | Chicago | Illinois | 60611 | United States |
| Body Aesthetic Research Center | St Louis | Missouri | 63141 | United States |
| Mercy Clinic Heart and Vascular | St Louis | Missouri | 63141 | United States |
| Long Island Plastic Surgical Group, P.C | Garden City | New York | 11530 | United States |
| Long Island Plastic Surgical Group, P.C. | Manhasset | New York | 11030 | United States |
| Laser Skin Surgery Center of NY | New York | New York | 10016 | United States |
| The Hunstad Kortesis Center for Cosmetic Surgery | Huntersville | North Carolina | 28078 | United States |
| Connall Consmetic Surgery | Tualatin | Oregon | 97062 | United States |
| Meridian Center for Surgical Excellence, LLC | Tualatin | Oregon | 97062 | United States |
| Timothy P. Connall, MD PC | Tualatin | Oregon | 97062 | United States |
| Office of Paul M. Glat ,MD | Bala-Cynwyd | Pennsylvania | 19004 | United States |
| Black Hill Surgical Hospital | Rapid City | South Dakota | 57702 | United States |
| Health Concepts | Rapid City | South Dakota | 57702 | United States |
| Fort Bend Imaging | Sugar Land | Texas | 77478 | United States |
| Luxe Plastic Surgery | Sugar Land | Texas | 77479 | United States |
| Virginia Clinical Research, Inc. | Norfolk | Virginia | 23507 | United States |
| Noahklinik,Klinik Plastische, Rekonstruktive und Asthetische Chirurgie, Handchirurgie am Roten Kreuz | Kassel | Hesse | 34121 | Germany |
| Magyar Honvedseg-Egeszsegugyi Kozpont | Budapest | Budapest | 1134 | Hungary |
| Hospital Santa Creu I Sant Pau | Barcelona | Barcelona | 08025 | Spain |
| Clinica La Luz | Madrid | Madrid | 28003 | Spain |
| FG001 |
| PF-06473871/Placebo (3* 5 mg/cm) |
Participants with bilateral hypertrophic scars received 3 intradermal injections of PF-06473871 at a dose of 5 milligrams per linear centimeter (mg/cm) (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Modified Intent To Treat (mITT) population included all participants who were randomized and received at least 1 dose of investigational product.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | PF-06473871/Placebo (4* 5 mg/cm) | Participants with bilateral hypertrophic scars received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm ( 2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast. |
| BG001 | PF-06473871/Placebo (3* 5 mg/cm) | Participants with bilateral hypertrophic scars received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast. |
| BG002 | 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 |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Pre-Surgery Physician Overall Opinion POSAS Score | Physician global assessment was performed using the overall opinion question of the POSAS scale. Physicians were asked to rate the severity of the participant's scar compared to normal skin. The overall opinion scale score ranged from 1 (normal skin) to 10 (worst imaginable scar). | Mean | Standard Deviation | units on scale |
| ||||||||||||||
| Pre-Surgery Subject Global Assessment Score | Patient global assessment was performed using the overall opinion question of the POSAS scale. Participants were asked to rate the severity of their scar compared to normal skin. The overall opinion scale score ranged from 1 (normal skin) to 10 (very different from normal skin). | Mean | Standard Deviation | units on scale |
| ||||||||||||||
| Pre-Surgery Physician Photoguide Score | Physician rated severity of each scar using a photonumeric guide on a scale ranging from 1 to 5 (where 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe). | Mean | Standard Deviation | units on scale |
| ||||||||||||||
| Pre-Surgery Participant Photoguide Score | Participants rated severity of each scar using a photonumeric guide on a scale ranging from 1 to 5 (where 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe). | Mean | Standard Deviation | units on scale |
|
| 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 | Physician Global Assessment Using Physician Overall Opinion Question of Patient and Observer Scar Assessment Scale (POSAS) | Physician global assessment was performed using the overall opinion question of the POSAS scale. Physicians were asked to rate the severity of the participant's scar compared to normal skin. The overall opinion scale score ranged from 1 (normal skin) to 10 (worst imaginable scar). Within participant treatment difference was assessed between the treatment regimens each participant received. | Modified Intent To Treat (mITT) population included all participants who were randomized and received at least 1 dose of investigational product. Here, N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | Least Squares Mean | Standard Error | units on scale | Week 24 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | Physician scar assessment was performed using 10-point POSAS scale. Physician rated each of the items (vascularity, pigmentation, thickness, relief, pliability, surface area and overall opinion) for a scar on a score of 1 (normal skin) to 10 (worst scar imaginable). Within participant treatment difference was assessed between the treatment regimens each participant received. Data for overall opinion scale score at Week 24 was not presented in this outcome measure because the data was reported separately under primary outcome measure 1. | mITT population included all participants who were randomized and received at least 1 dose of investigational product. Here,"n""= participants who were evaluable at given time point for each arm, respectively. | Posted | Least Squares Mean | Standard Error | units on scale | Week 8, 11, 18, 24 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Patient Global Assessment Using Overall Opinion of Patient and Observer Scar Assessment Scale (POSAS) | Patient global assessment was performed using the overall opinion question of the POSAS scale. Participants were asked to rate the severity of their scar compared to normal skin. The overall opinion scale score ranged from 1 (normal skin) to 10 (very different from normal skin). Within participant treatment difference was assessed between the treatment regimens each participant received | mITT population included all participants who were randomized and received at least 1 dose of investigational product. Here, "n""= participants who were evaluable at given time point for each arm, respectively. | Posted | Least Squares Mean | Standard Error | units on scale | Week 8, 11, 18, 24 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Patient-Reported Scar Evaluation Questionnaire (PR-SEQ) Symptoms and Appearance Domains Score | PR-SEQ questionnaire consisted of 30 different attributes of scars that included following four dimensions: appearance (5 attributes), symptoms (3 attributes), bothersomeness (8 attributes), and impacts on the quality of life (physical and emotional wellbeing [14 attributes]). Each question had 5 possible responses: not at all (0), slightly (1), moderately (2), very (3), and extremely (4). Participants completed an abbreviated version which included only the Symptoms and Appearance dimensions to evaluate treatment outcomes. Each of the item scores were transformed into a 0 to 100 scale. Each dimension score was calculated from averaging the transformed scores (0-100 scaled) for specified items. Each domain score ranged from 0 to 100, with higher scores indicating higher severity. Within participant treatment difference was assessed between the treatment regimens each participant received. | mITT population included all participants who were randomized and received at least 1 dose of investigational product. Here,"n""= participants who were evaluable at given time point for each arm, respectively. | Posted | Least Squares Mean | Standard Error | units on scale | Week 8, 24 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Physician and Participant Photoguide Scar Assessment Scale Score | Physician and participants rated severity of each scar using a photonumeric guide on a scale ranging from 1 to 5 (where 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe). Within participant treatment difference was assessed between the treatment regimens each participant received. | mITT population included all participants who were randomized and received at least 1 dose of investigational product. Here, "n"= participants who were evaluable at given time point for each arm, respectively. | Posted | Least Squares Mean | Standard Error | units on scale | Week 8, 11, 18, 24 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With Clinically Significant Vital Sign Abnormalities | Vital Sign included pulse rate, systolic blood pressure, diastolic blood pressure, and weight. | Safety population included all participants who received at least 1 dose of investigational product. | Posted | Number | participants | Baseline up to Week 24 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With Abnormal Physical Examinations | Physical examination included examination of skin, head, eyes, ears, nose, throat (HEENT), respiratory, cardiovascular, abdomen - liver and kidney, musculoskeletal, gastrointestinal, genitourinary, and neurological systems. | Safety population included all participants who received at least 1 dose of investigational product. | Posted | Number | participants | Baseline up to Week 24 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With Electrocardiogram Findings | Following parameters were assessed: heart rate, PR Interval, QRS Interval, QT Interval, and Fridericia's Correction Formula (QTcF) interval. Electrocardiogram Results were reported as normal, abnormal, not clinically significant (NCS) and abnormal and clinically significant (CS) as determined by investigator. | Safety population included all participants who received at least 1 dose of investigational product. Here, "n""= participants who were evaluable at given time point for each arm, respectively. | Posted | Number | participants | Baseline, Week 11 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With Treatment Emergent Adverse Events (AEs) of Special Interest | Treatment Emergent Adverse Events (AEs) of special interest included injection site erythema, maculopapular rash, pruritus, bronchospasm, dyspnea, cough, fever and diarrhea. | Safety population included all participants who received at least 1 dose of investigational product. Here, "N" (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | Number | participants | Baseline up to Week 24 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Laboratory Abnormalities | An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent adverse event are events between first dose of study drug and up to Week 24 that were absent before treatment or that worsened relative to pre-treatment state. TEAEs related to laboratory abnormalities are reported. | Safety population included all participants who received at least 1 dose of investigational product. | Posted | Number | participants | Baseline up to Week 24 |
|
Baseline up to Week 24
There was no overall separate placebo group for safety assessment as each participant received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
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 | PF-06473871/Placebo (4* 5 mg/cm) | Participants with bilateral hypertrophic scars received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast. | 0 | 45 | 30 | 45 | ||
| EG001 | PF-06473871/Placebo (3* 5 mg/cm) | Participants with bilateral hypertrophic scars received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast. | 0 | 55 | 35 | 55 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site erythema | General disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Incision site pain | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
| |
| Incision site pruritus | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
| |
| Procedural site reaction | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
| |
| Burns second degree | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
| |
| Incision site complication | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
| |
| Post procedural swelling | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
| |
| Procedural headache | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
| |
| Procedural nausea | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
| |
| Procedural vomiting | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
| |
| Suture rupture | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
| |
| Incision site blister | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
| |
| Incision site erythema | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Application site rash | General disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Injection site rash | General disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Injection site urticaria | General disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Vaginal infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Viral rhinitis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Hyperaesthesia | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Piriformis syndrome | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Scar pain | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Itching scar | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Gingival pain | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Breast haematoma | Reproductive system and breast disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Breast mass | Reproductive system and breast disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Menstruation irregular | Reproductive system and breast disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Motion sickness | Ear and labyrinth disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Folate deficiency | Metabolism and nutrition disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Treatment noncompliance | Social circumstances | MedDRA 15.1 | 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_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D002921 | Cicatrix |
| D017439 | Cicatrix, Hypertrophic |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| A total sample size of 100 (accounting for approximately 10% drop rate) that is approximately 50 per group at one sided 0.05 level with delta of 1.5 points with standard deviation of 2 provided at least 80% power to detect a difference from placebo using a paired test. Statistical significance was tested at the two-sided significance level of 0.1, without adjusting for multiplicity. | Repeated measures model | Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871 | 0.4038 | Least Square mean difference | 0.24 | Standard Error of the Mean | 0.29 | 2-Sided | 90 | -0.24 | 0.72 | No | Superiority or Other |
| OG002 | Group 2: PF-06473871: (3* 5 mg/cm) | Participants with bilateral hypertrophic scars received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, and 8. |
| OG003 | Group 2: Placebo 3* 5 mg/cm | Participants who received 3 intradermal injections of PF-06473871 on one breast, also received 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, and 8 on another breast. |
|
|
|
Participants with bilateral hypertrophic scars received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, and 8. |
| OG003 | Group 2: Placebo 3* 5 mg/cm | Participants who received 3 intradermal injections of PF-06473871 on one breast, and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, and 8 on another breast. |
|
|
|
Participants who received 4 intradermal injections of PF-06473871 on one breast, and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8, and 11 on another breast. |
| OG002 | Group 2: PF-06473871: (3* 5 mg/cm) | Participants with bilateral hypertrophic scars received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, and 8. |
| OG003 | Group 2: Placebo 3* 5 mg/cm | Participants who received 3 intradermal injections of PF-06473871 on one breast, and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, and 8 on another breast. |
|
|
|
| OG003 | Group 2: Placebo 3* 5 mg/cm | Participants who received 3 intradermal injections of PF-06473871 on one breast, and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, and 8 on another breast. |
|
|
|
|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|