Safety and Efficacy Study of EXC 001 to Improve the Appearance of Scars From Prior Breast Surgery

Study Overview
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Brief Summary
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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.

Official Title
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A PHASE 2, RANDOMIZED, DOUBLE-BLIND, WITHIN-SUBJECT CONTROLLED STUDY TO EVALUATE EFFICACY AND SAFETY OF VARIOUS DOSES AND REGIMENS OF EXC 001 FOR THE AMELIORATION OF SCARRING FOLLOWING REVISION OF SCARS FROM PRIOR BREAST SURGERY IN ADULT SUBJECTS (LEGACY EXCALIARD PROTOCOL # EXC 001-204)

Conditions
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Reduction in Hypertrophic Skin Scarring

Intervention / Treatment
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* Drug: EXC 001
* Drug: EXC 001
* Drug: EXC 001
* Drug: EXC 001


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: EXC 001<br>* Single-dose administered by injection four different times<br>|
| Placebo Comparator: Group 2<br> | Drug: EXC 001<br>* Single reduced dose compared to Group 1 administered by injection at the same four time periods as Group 1<br>|
| Placebo Comparator: Group 3<br> | Drug: EXC 001<br>* Single reduced dose compared to Groups 1 and 2 administered by injection at the same four time periods as Groups 1 and 2<br>|
| Placebo Comparator: Group 4<br> | Drug: EXC 001<br>* Same sinlge dose as Group 1 administered by injection at the same four time periods as Groups 1, 2, and 3<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Week 11, 18, 24 | 
| Subject Observer Scar Assessment Score | 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. | 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). | 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). | Week 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