Safety and Efficacy of AR/101 in Accelerating Re-epithelialization of Split Thickness Wounds

Wounds and Injuries Clinical Trial

Official title: 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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Wounds and Injuries

• NCT number: NCT02602184
• Study type: Interventional
• Source: Arava Bio Tech Ltd.
• Contact: Tamar Tennenbaum, MD, Ph.D
• Phone: 972-9-8343015
• Email: tamar@arava-bio.com
• Status: Recruiting
• Phase: Phase 2
• Start date: November 2015
• Completion date: June 2017