Prospective, Placebo-controlled, Double Blind, Randomized Intra-individual Comparative Clinical Study to Assess the Safety and Efficacy of AR/101 Compared to Placebo in Accelerating Re-epithelialization of Split Thickness Wounds
Overview
- Phase
- Phase 2
- Intervention
- AR/101
- Conditions
- Wounds and Injuries
- Sponsor
- Arava Bio Tech Ltd.
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- The number of days, per wound within a subject, from treatment initiation to complete re epithelialization.
- Last Updated
- 9 years ago
Overview
Brief Summary
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.
Detailed 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.
Investigators
Eligibility 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.
Exclusion Criteria
- •Subject has prior history of panniculectomy, circumferential lipectomy, lower body lift, belt lipectomy.
- •Subject has combined procedures (such as concurrent breast augmentation, etc.).
- •Subject has body mass index (BMI) \< 20 or \>
- •Subject has existing scars or significant striae on the abdominal pannus to be removed during the abdominoplasty procedure, with the exception of vertical midline scars or scars at the periphery (such as transverse Caesarian scars at the level of the pubis) that would not interfere with this study.
- •Subject has a systemic infection or significant local infection such as cellulitis, purulent drainage, gangrene, or necrosis at the target wound site, as well as nonviable tissue, sinus tracts or tunnels that cannot be removed by debridement.
- •Subject has a skin disorder which is chronic or currently active (e.g. cutis laxa, radiation damage, sun damage, etc.) or other skin condition which in the opinion of the investigator will adversely affect the healing ability of the patient according to the protocol.
- •Subject has a history of skin sensitivity (dermatitis) to the dressings to be utilized during the course of this study.
- •Subject has had aggressive liposuction or lipodissolve therapy that resulted in inadequate subcutaneous fat so that the skin in the study area is compromised.
- •Subject has an abdominal hernia that in the opinion of the investigator would interfere with the conduct of this study.
- •Subject has previous history or presence of malignancies, or of any illness or condition that may impair re-epithelialization or healing, immune deficiency or connective tissue disease (e.g., SLE, AIDS), neurological disease (e.g., multiple sclerosis), circulatory disease, peripheral vascular disease, dialysis due to renal disease, active hepatic disease, significant cardiovascular, pulmonary, hematological, gastrointestinal, endocrine, immunologic, dermatologic or psychiatric abnormalities.
Arms & Interventions
AR/101
Topically treatment with AR/101+Standard of Care once daily for up to 21 days. Daily treatment will include application of AR/101 drug to the wound and coverage with dressing (SoC). Subjects 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. 4 of the wounds will be treated with AR/101.
Intervention: AR/101
Placebo
Topically treatment with Placebo + Standard of Care once daily for up to 21 days. Daily treatment will include application of placebo control to the wound and coverage with dressing (SoC). Subjects 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. 4 of the wounds will be treated with Placebo.
Intervention: Placebo
Outcomes
Primary Outcomes
The number of days, per wound within a subject, from treatment initiation to complete re epithelialization.
Time Frame: Up to 21 days
Secondary Outcomes
- The number of days, per wound within a subject, from treatment initiation to reach 50% re-epithelialization(Up to 21 days)
- Percentage of split thickness wounds with full re-epithelialization(Up to 21 days)
- The number of days, per wound within a subject, from treatment initiation to reach 75% re-epithelialization(Up to 21 days)