Safety and Efficacy Study of PF-06473871 to Reduce Hypertrophic Scars From Recurring Post-Revision Surgery
- Registration Number
- NCT01730339
- Lead Sponsor
- Pfizer
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 103
- Subjects must have hypertrophic (raised) breast scars from previous surgery
- Subjects must be healthy
- Currently pregnant or pregnant during the 6 months, prior to inclusion in the study or breast-feeding.
- Presence of history of breast cancer
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group 1 PF-06473871 - Group 2 PF-06473871 -
- Primary Outcome Measures
Name Time Method Physician Global Assessment Using Physician Overall Opinion Question of Patient and Observer Scar Assessment Scale (POSAS) Week 24 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.
- Secondary Outcome Measures
Name Time Method Patient Global Assessment Using Overall Opinion of Patient and Observer Scar Assessment Scale (POSAS) Week 8, 11, 18, 24 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
Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) Week 8, 11, 18, 24 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.
Patient-Reported Scar Evaluation Questionnaire (PR-SEQ) Symptoms and Appearance Domains Score Week 8, 24 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.
Physician and Participant Photoguide Scar Assessment Scale Score Week 8, 11, 18, 24 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.
Trial Locations
- Locations (39)
University of California Irvine - Dermatology Research
🇺🇸Irvine, California, United States
Plastic Surgery and Laser Institute of San Diego
🇺🇸La Jolla, California, United States
Scripps Memorial-Ximed Medical Center
🇺🇸La Jolla, California, United States
Advanced Cosmetic Surgery Clinic of Walnut Creek
🇺🇸Walnut Creek, California, United States
Anthony DeMeo, MD
🇺🇸Walnut Creek, California, United States
Charles Hanson MD
🇺🇸Walnut Creek, California, United States
PIH Health Plastic Surgery and Aesthetic Medicine
🇺🇸Whittier, California, United States
PIH health
🇺🇸Whittier, California, United States
Sanctuary Mediacal Center
🇺🇸Boca Raton, Florida, United States
Stephan Baker, MD PA
🇺🇸Coral Gables, Florida, United States
Scroll for more (29 remaining)University of California Irvine - Dermatology Research🇺🇸Irvine, California, United States