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This clinical study will be a prospective, placebo-controlled, double-blind, randomized and centrally evaluated intra-individual comparative study to assess the safety and efficacy of AR/101 concomitantly administered with Standard of Care (SoC) in accelerating re epithelialization of split thickness wounds compared with placebo and concomitantly with SoC, in the pannus of volunteers undergoing elective abdominoplasty.
Full description
This clinical study will be a prospective, placebo-controlled, double-blind, randomized and centrally evaluated intra-individual comparative study to assess the safety and efficacy of AR/101 concomitantly administered with SoC in accelerating re epithelialization of split thickness wounds compared with placebo and concomitantly with SoC, in the pannus of volunteers undergoing elective abdominoplasty.
Total duration of the treatment in the study is 21 days. The patients will be treated with AR/101 or placebo until complete re epithelialization or up to 21 days, whichever comes first. Evaluation and treatment will be done daily in the outpatient clinic. Throughout the study, safety data on adverse events will be collected.
All patients will receive standard supportive care and dressing supplies concomitantly with AR/101 or placebo.
Volunteers who are scheduled for an elective abdominoplasty at the practice of the principal investigator will have superficial split thickness wounds created on their abdomen according to protocol about 4 weeks prior to their scheduled abdominoplasty. A total of 8 split thickness (5X5 cm, 0.0254 mm in thickness) wounds will be distributed on the abdomen between the umbilicus and the suprapubic hairline. All patients will have to agree to daily treatment in the hospital clinic by professional staff through the study duration. Degree of re-epithelialization will be assessed photographically and confirmed by the absence of drainage on wound dressings.
All treated wounds that achieve complete re-epithelialization within the study period will be evaluated for the retention of an intact epithelium at the end of the study (22 days). At the time of the subject's abdominoplasty surgery, the pannus of each subject will be surgically removed as part of the abdominoplasty procedure, and skin samples will be harvested from the excised pannus for further histologic and molecular analysis.
Enrollment
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Volunteers
Inclusion and exclusion criteria
Inclusion Criteria:
The subject is 25-55 years old
Patient has chosen to undergo and scheduled an elective cosmetic abdominoplasty
Subject has sufficient excess abdominal tissue to qualify for a standard elective abdominoplasty. [Standard abdominoplasty including minor liposuction of the abdominal flap, mons pubis (female patients), and flanks.]
Subject is able to tolerate up to a 4 hour abdominoplasty operation under conscious sedation and local tumescent anesthesia, or general anesthesia.
Subject donor site can accommodate up to 8, 5X5 cm split thickness wounds which will be distributed on the abdomen between the umbilicus and the suprapubic hairline as per the Principal Investigator.
Subject is medically healthy with normal laboratory and ECG screening results (or with values that are outside of the normal range but not considered clinically significant, as per the Principal Investigator).
Subject is ready to comply with all study requirements, including: visiting the trial site for daily dressing changes and photo documentation for 22 days
The patient is willing and able to adhere to the protocol regimen.
For female subjects only, the subject is either:
Surgically sterile. 2. At least 1 year post-menopausal. 3. Subject has consented to using one of the following acceptable methods of birth control for the times specified below:
Intra-uterine device (IUD) in place for at least 3 months prior to screening visit and through study completion.
Barrier method (condom or diaphragm) for at least 14 days prior to screening through study completion.
Spermicide for at least 14 days prior to screening through study completion.
Stable hormonal contraceptive for at least 3 months prior to screening visit through study completion.
Surgical Sterilization (vasectomy) of partner at least 6 months prior to screening visit through study completion.
Subject is non-smoker or stopped smoking at least 6 weeks before study start; subject has negative cotinine test.
The patient is able to read, understand, and has signed the informed consent form. In case of compromised mental capacity, approval and signature of a legal guardian is required.
Exclusion Criteria:
Primary purpose
Allocation
Interventional model
Masking
18 participants in 2 patient groups, including a placebo group
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Central trial contact
Yulia Binyamin, LL.B; Tamar Tennenbaum, MD, Ph.D
Data sourced from clinicaltrials.gov
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