Safety and Efficacy Study of Different Dose Levels of EXC 001 to Improve the Appearance of Scars in Subjects Undergoing Elective Abdominoplasty

Study Overview
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Brief Summary
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This study will compare how well EXC 001 works versus placebo in reducing the appearance of scars in subjects undergoing elective abdominoplasty. 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, DOSE-RANGING STUDY TO EVALUATE EFFICACY AND SAFETY OF EXC 001 FOR THE TREATMENT OF INCISION SCARS IN THE PANNUS OF SUBJECTS UNDERGOING AN ELECTIVE ABDOMINOPLASTY

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 sufficient excess abdominal tissue to qualify for a standard elective abdominoplasty Subject has chosen to have an elective abdominoplasty Medically healthy with normal screening results Subjects must not be pregnant or lactating Exclusion Criteria: Subjects with existing scars or significant striae on the abdominal pannus Females who are currently pregnant or pregnant during the 12 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: 45 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
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EXC 001<br> | Drug: EXC 001<br>* Intradermal injections of EXC 001 and placebo given on various schedules.<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Intradermal injections of EXC 001 and placebo given on various schedules.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Part B: 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 mm = best possible scar and a score of 100 mm = worst possible scar, where higher scores indicate worse condition. The difference was calculated for scars at Week 13 as EXC 001 score minus placebo score, thus a negative difference would indicate that the EXC 001-treated scars had lower scar severity. The score was defined as the within participant average difference between EXC 001- and Placebo-treated scars at Week 13. | Week 13 of Part B | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Part B: Physician Observer Global Assessment Scar Score | Physician observer global assessment of scar score was done using a valid published 10-point rating scale. Physicians rated severity of each scar on a scale of 1 = normal skin to 10 = worst scar imaginable. Each scar was given a single score and the differences in scores between the matched pairs of scars were calculated. There were 4 differences within each dose level that were averaged to create a single score for each participant at each dose level. The score was defined as the within participant average difference between EXC 001 and Placebo. | Week 13 of Part B | 
| Part B: Number of Participants With Clinically Significant Change From Baseline in Vital Signs | Following vital sign parameters were assessed: diastolic blood pressure, systolic blood pressure, respiration rate, pulse rate, temperature and weight. Number of participants with clinically significant change in any vital sign parameter compared to Baseline were reported. Criteria for clinically significant change in any vital sign parameter compared to baseline was based on investigator's discretion. | Part B: Day 1 up to Week 14 | 
| Part B: Number of Participants With Clinically Significant Changes in 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. Criteria for clinically significant findings in physical examination was based on investigator's discretion. | Part B: Day 1 up to Week 14 | 
| Part B: Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Findings | Following parameters were analyzed for ECG abnormality: PR interval, QRS interval, QT interval, QT interval corrected using the Fridericia's correction (QTc), heart rate (HR). A standard, single 12-lead ECG was taken and results was classified as normal, having a clinically insignificant abnormality, or having a clinically significant abnormality. Number of participants with clinically significant abnormality in ECG compared to baseline were reported. Criteria for clinically significant abnormality in ECG compared to baseline was based on investigator's discretion. | Week 13 of Part B | 
| Part B: Number of Participants With Clinically Significant Abnormal Laboratory Findings | 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 abnormal change in any laboratory parameter compared to baseline were reported. | Part B: Day 1 up to Week 13 | 
| Part A and B: Number of Participants With Positive Skin Sensitivity Reaction | The skin sensitivity reaction was assessed only at the skin sensitivity reaction testing sites. Erythematous, raised (indurated) and edematous reactions were considered as positive skin sensitivity reactions. The number of participants that experienced any positive skin sensitivity reactions were reported. | From Day 21 of Part A up to Week 2 of Part B | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Scarring