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

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.

Inclusion Criteria:

1. The subject is 25-55 years old

2. Patient has chosen to undergo and scheduled an elective cosmetic abdominoplasty

3. 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.]

4. Subject is able to tolerate up to a 4 hour abdominoplasty operation under conscious
sedation and local tumescent anesthesia, or general anesthesia.

5. 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.

6. 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).

7. Subject is ready to comply with all study requirements, including: visiting the trial
site for daily dressing changes and photo documentation for 22 days

8. The patient is willing and able to adhere to the protocol regimen.

9. For female subjects only, the subject is either:

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:

1. Intra-uterine device (IUD) in place for at least 3 months prior to screening visit
and through study completion.

2. Barrier method (condom or diaphragm) for at least 14 days prior to screening through
study completion.

3. Spermicide for at least 14 days prior to screening through study completion.

4. Stable hormonal contraceptive for at least 3 months prior to screening visit through
study completion.

5. 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:

1. Subject has prior history of panniculectomy, circumferential lipectomy, lower
body lift, belt lipectomy.

2. Subject has combined procedures (such as concurrent breast augmentation, etc.).

3. Subject has body mass index (BMI) < 20 or > 35.

4. 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.

5. 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.

6. 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.

7. Subject has a history of skin sensitivity (dermatitis) to the dressings to be
utilized during the course of this study.

8. Subject has had aggressive liposuction or lipodissolve therapy that resulted in
inadequate subcutaneous fat so that the skin in the study area is compromised.

9. Subject has an abdominal hernia that in the opinion of the investigator would
interfere with the conduct of this study.

10. 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.

11. Subject has a previous medical documentation of positive testing for human
immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis
C antibodies (HCV).

12. Patients with current known history of diabetes

13. Patient is receiving, or plans to while on study, or has received within 14 days
prior to Visit 0 any medication (with exception of hormonal contraceptives and
HRT) known to impair re-epithelialization or healing, including but not limited
to: steroids (topical, injected, consumed, or inhaled) or other immune
modulators, corticosteroids, immuno-suppressive drugs, cytotoxic agents,
radiation therapy and chemotherapy, NSAIDs, aspirin or other blood thinners; OR
any other treatment that in the investigator's judgment will affect wound
healing or bleeding.

14. Subject has a history or presence of alcoholism or drug abuse within the 2 years
prior to Visit 0.

15. Female patient who is pregnant, or was pregnant during the 12 months prior to
inclusion in the study, or nursing, or of childbearing potential which is not
using adequate contraception.

16. Patients who in the opinion of the investigator, for any reason other than those
listed above will not be able to complete the study per protocol.

17. Participation in another clinical trial within 30 days prior to the Screening
Visit or during this study.

18. History of mental illness that would preclude completion of the study

19. Subject has history of anaphylactic reactions.