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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This study will compare how well EXC 001 works to improve the appearance of scars in subjects undergoing breast scar revision surgery. The study will also evaluate the safety of EXC 001 in healthy adult subjects.

Official Title
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A PHASE 2, RANDOMIZED, DOUBLE-BLIND, WITHIN-SUBJECT CONTROLLED STUDY TO EVALUATE EFFICACY AND SAFETY OF EXC 001 FOR THE AMELIORATION OF SCARRING FOLLOWING REVISION OF SCARS RESULTING FROM PRIOR BREAST SURGERY IN ADULT FEMALE SUBJECTS

Conditions
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Scar Prevention

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must have previously had breast surgery resulting in unacceptable scars Subject has chosen to have the breast scars revised Subjects 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 this study

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

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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 |
| --- | --- |
| Experimental: EXC 001<br> | Drug: EXC 001<br>* Multiple intradermal injections of EXC 001 and placebo<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Multiple intradermal injections of EXC 001 and placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expert Panel Scar Assessment Score at Week 12 | Scar assessment by an expert panel was done on blinded photographs using 100 millimeter (mm) visual analog scale (VAS) where a score of 0 mm = best possible scar and a score of 100 mm = worst possible scar, where higher scores indicate worse condition. | Part B: Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expert Panel Scar Assessment Score at Week 8 and 24 | Scar assessment by an expert panel was done on blinded photographs using 100 mm VAS where a score of 0 mm = best possible scar and a score of 100 mm = worst possible scar, where higher scores indicate worse condition. | Part B: Week 8 and 24 | 
| Physician Observer Scar Assessment Score at Week 12 and 24 | Physician observer 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 a scar on a score of 1= normal skin to 10= worst scar imaginable, where higher scores indicate worse condition. 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 higher scores indicate worse condition. | Part B: Week 12 and 24 | 
| Participant Observer Scar Assessment Score at Week 12 and 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), where higher scores indicate worse condition. Composite score = sum of all scores except overall opinion, range 6 (best) to 60 (worst), where higher scores indicate worse condition. Scar appearance composite score = sum of all scores except overall opinion, pain and itching, range 4 (best) to 40 (worst), where higher scores indicate worse condition. | Part B: Week 12 and 24 | 
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included SAEs and all non-SAEs that occurred during the study. | Part A: Day 1; Part B, Active Dosing: Week 2 up to Week 13; Part B, Post Dosing: Week 13 to end of the study (Week 24) | 
| Number of Participants With Abnormal Physical Examination Findings | Physical examination included the assessment of skin; head, ears, eyes, nose, and throat; respiratory; cardiovascular; abdomen; musculoskeletal; neurological; gastrointestinal; genitourinary; endocrine and lymph nodes. Abnormal physical examination findings was based on investigator's discretion. | Screening (up to Day 21 prior to Day 1 of Part A), Part B: Day 1, Week 12 | 
| Number of Participants With Clinically Significant Findings in Electrocardiogram (ECG) | Number of participants with clinically significant abnormality in ECG were reported. Clinical significance was based on investigator's discretion. | Screening (up to Day 21 prior to Day 1 of Part A), Part B: Week 12 | 
| Number of Participants With Clinically Significant Findings in Laboratory Examinations | Laboratory analysis included hematology, biochemistry and urinalysis. Hematology range: basophils (bas) 0-0.2, eosinophils (eos) 0-0.4, leukocytes (leu) 4-10.5, lymphocytes (lym) 0.7-4.5, neutrophils (neu) 1.8-7.8, platelet 140-415, monocytes (mon) 0.1-1 in 10^9 per liter; bas/leu 0-3, eos/leu 0-7, lym/leu 14-46, mon/leu 4-13, neu/leu and neu/leu 40-74 in percentage, erythrocytes 3.8-5.1 10^12/L, hematocrit 0.34-0.44 L/L, hemoglobin 115-150 gram per liter (g/L). Biochemistry range: creatine kinase 24-173, alkaline phosphatase 25-150, alanine aminotransferase (AT) and aspartate AT 0-40 in International units per liter; creatinine 50-88, urate 89-399, bilirubin 2-21 in micromole per liter, glucose 3.6-5.5, potassium 3.5-5.5, sodium 135-148, blood urea nitrogen 1.8-9.3 in millimole/L, albumin 35-55 g/L. Urinalysis parameters: pH (5-7.5), specific gravity (1.005-1.03). Participants with clinically significant findings were reported. | Screening (up to Day 21 prior to Day 1 of Part A), Part B: Day 1 up to Week 12 | 
| Number of Participants With Clinically Significant Findings in Vital Signs | Following vital sign parameters were assessed: diastolic blood pressure, systolic blood pressure, respiration rate, pulse rate, and temperature. Clinical significance was based on investigator's discretion. | Screening (up to Day 21 prior to Day 1 of Part A), Part B: Day 1 up to Week 12 | 
| Number of Participants With Positive Skin Sensitivity Reaction | Participants were instructed to inform the investigator in case of any itching, redness, pain or any other symptom that appears to be a rash at the injection sites. Erythematous, raised (indurated) and edematous reactions were considered as positive skin sensitivity reactions. | Part A: Day 1, Part B: Week 2 up to Week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Scarring, Cicatrix, Fibrosis, Pathologic Process