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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
68
Single-dose administered by injection four different times
Single reduced dose compared to Group 1 administered by injection at the same four time periods as Group 1
Single reduced dose compared to Groups 1 and 2 administered by injection at the same four time periods as Groups 1 and 2
Skin Deep Laser Medical Spa
Pasadena, California, United States
Bright Health Physicans Plastic Surgery and Aesthetic Medicine
Whittier, California, United States
Altus Research
Lake Worth, Florida, United States
Physician Observer Scar Assessment Score at 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.
Time frame: Week 24
Physician Observer Scar Assessment Score
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.
Time frame: Week 11, 18
Expert Panel Scar Assessment Score
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.
Time frame: Week 11, 18, 24
Subject Observer Scar Assessment Score
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Same sinlge dose as Group 1 administered by injection at the same four time periods as Groups 1, 2, and 3
Bayside Ambulatory Center
Miami, Florida, United States
Aesthetic Plastic Surgery Miami
Miami, Florida, United States
Body Aesthetic Plastic Surgery
St Louis, Missouri, United States
New Jersey Plastic Surgery
Montclair, New Jersey, United States
Mark L. Jewell,MD Surgery Center
Eugene, Oregon, United States
Connall Consmetic Surgery
Tualatin, Oregon, United States
Endeavor Clinical Trials,P.A.
San Antonio, Texas, United States
...and 2 more locations
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.
Time frame: Week 24
Number of Participants With Physician Photonumeric Guide Scar Assessment Score
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).
Time frame: Week 24
Number of Participants With Participant Photonumeric Guide Scar Assessment Score
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).
Time frame: Week 24