Safety and Efficacy Study of PF-06473871 to Reduce Hypertrophic Scars From Recurring Post-Revision Surgery

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 2, Randomized, Double-blind, Within-subject, Placebo Controlled Study To Evaluate The Efficacy And Safety Of Pf 06473871 In Reducing Hypertrophic Skin Scarring

Conditions
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Reduction of Hypertrophic Skin Scarring

Intervention / Treatment
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* Drug: PF-06473871
* Drug: PF-06473871


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must have hypertrophic (raised) breast scars from previous surgery Subjects must be healthy Exclusion Criteria: Currently pregnant or pregnant during the 6 months, prior to inclusion in the study or breast-feeding. Presence of history of breast cancer

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br> | Drug: PF-06473871<br>* Single dose administered by injection four different times<br>|
| Active Comparator: Group 2<br> | Drug: PF-06473871<br>* Single dose administered by injection three different times<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Skin scarring, cicatrix, breast scar, hypertrophic scar