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| Name | Class |
|---|---|
| Cato Research | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AR/101 | Experimental | 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. |
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| Placebo | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AR/101 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| The number of days, per wound within a subject, from treatment initiation to complete re epithelialization. | Up to 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| The number of days, per wound within a subject, from treatment initiation to reach 50% 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 |
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Inclusion Criteria:
1. 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.
10. Subject is non-smoker or stopped smoking at least 6 weeks before study start; subject has negative cotinine test.
11. 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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tamar Tennenbaum, MD, Ph.D | Contact | 972-9-8343015 | tamar@arava-bio.com | |
| Yulia Binyamin, LL.B | Contact | 972-9-8343015 | yulia@arava-bio.com |
| Name | Affiliation | Role |
|---|---|---|
| Robert Galiano, MD FACS | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University Feinberg School of Medicine | Recruiting | Chicago | Illinois | 60611 | United States |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| Percentage of split thickness wounds with full re-epithelialization | Up to 21 days |