Safety and Efficacy Study of EXC 001 to Improve the Appearance of Scars From Prior Breast Surgery
- Registration Number
- NCT01346969
- Lead Sponsor
- Pfizer
- Brief Summary
The study will investigate the efficacy of various doses and regimens of EXC 001 in reducing skin scarring in subjects undergoing revision of scars from prior surgery. The study will also evaluate the safety and tolerability of EXC 001 and placebo.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 68
- Subjects must have previous had breast surgery resulting in unacceptable scars.
- Subject has chosen to have breast scars revised.
- Subject must not be pregnant or lactating.
- Currently pregnant or pregnant during the 6 months, prior to inclusion in the study or lactating.
- Participation in another clinical trial within 30 days prior to the start of the study.
- Any other condition or prior therapy, which, in the opinion of the PI, would make the subject unsuitable for the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group 1 EXC 001 - Group 2 EXC 001 - Group 3 EXC 001 - Group 4 EXC 001 -
- Primary Outcome Measures
Name Time Method Physician Observer Scar Assessment Score at Week 24 Week 24 Physician assessment of scar was done using a valid published 10-point rating scale. Physician rated vascularity, pigmentation, thickness, relief, pliability, surface area and overall opinion for scar on a score of 1 = normal skin to 10 = worst scar imaginable, where lower scores indicated better outcome. Composite score was the sum of all the scores, except the overall opinion score, and range from 6 (best score) to 60 (worst score), where lower scores indicated better outcome. Within participant treatment difference was assessed between the treatment regimens each participant received.
- Secondary Outcome Measures
Name Time Method Physician Observer Scar Assessment Score Week 11, 18 Physician observer scar assessment score was done using a valid published 10-point rating scale. Physician rated 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, where lower scores indicated better outcome. Composite score was the sum of all the scores except the overall opinion score and range from 6 (best score) to 60 (worst score), where lower scores indicated better outcome. Within participant treatment difference was assessed between the treatment regimens each participant received.
Number of Participants With Physician Photonumeric Guide Scar Assessment Score Week 24 Physician rated severity of each scar using a photonumeric guide on a scale range from 1 to 5 (where 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe). Number of participants with different ratings of scar severity were reported. Same participant was reported twice, once for each breast's scar (dosing for 1 breast = 4 times EXC 001 and for other breast = 3 times).
Subject Observer Scar Assessment Score Week 24 Participants rated pain, itching, color, stiffness, thickness, irregularity, and overall opinion of scar on 10-point scale. For pain and itching associated with scar: range = 1 (no, not at all) to 10 (yes, worst imaginable) and for other parameters associated with scar compared to normal skin: range = 1 (no, same as normal skin) to 10 (yes, very different). Composite score = sum of all scores except overall opinion and range 6 (best) to 60 (worst). Scar appearance composite score = sum of all scores except overall opinion, pain and itching, range 4 (best) to 40 (worst). Within participant treatment difference was assessed between the treatment regimens each participant received. A lower score indicated a better outcome.
Number of Participants With Participant Photonumeric Guide Scar Assessment Score Week 24 Participants rated severity of each scar using a photonumeric guide on a scale range from 1 to 5 (where 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe). Number of participants with different ratings of scar severity were reported. Same participant was reported twice, once for each breast's scar (dosing for 1 breast = 4 times EXC 001 and for other breast = 3 times).
Expert Panel Scar Assessment Score Week 11, 18, 24 Scar assessment by an expert panel was done on blinded photographs using 100 millimeter (mm) visual analog scale (VAS) where a score of 0 = best possible scar and a score of 100 = worst possible scar, where lower scores indicated better outcome. The rater first marked a rating for the "worse" scar and then rated the other scar. The difference between these two ratings was the "improvement of scar severity." If there was no difference, the expert could check a box to indicate that determination. This method provided information on the absolute severity of the scars as well as the differences between the two scars in the pair.
Trial Locations
- Locations (12)
Bayside Ambulatory Center
🇺🇸Miami, Florida, United States
Endeavor Clinical Trials,P.A.
🇺🇸San Antonio, Texas, United States
Aesthetic Plastic Surgery Miami
🇺🇸Miami, Florida, United States
Skin Deep Laser Medical Spa
🇺🇸Pasadena, California, United States
Bright Health Physicans Plastic Surgery and Aesthetic Medicine
🇺🇸Whittier, California, United States
Texas Plastic Surgery
🇺🇸San Antonio, Texas, United States
Altus Research
🇺🇸Lake Worth, Florida, United States
Body Aesthetic Plastic Surgery
🇺🇸Saint Louis, Missouri, United States
New Jersey Plastic Surgery
🇺🇸Montclair, New Jersey, United States
BAXTER Plastic Surgery
🇺🇸Mountlake Terrace, Washington, United States
Mark L. Jewell,MD Surgery Center
🇺🇸Eugene, Oregon, United States
Connall Consmetic Surgery
🇺🇸Tualatin, Oregon, United States