Wounds and InjuriesPhase 2NCT02602184
Safety and Efficacy of AR/101 in Accelerating Re-epithelialization of Split Thickness Wounds
A Phase 2 study testing AR/101 in people with Wounds and Injuries, run by Arava Bio Tech Ltd. at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Wounds and Injuries
- What is being tested?
- AR/101
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Jun 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
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- 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:
- 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.
Who cannot join
- 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 > 35.
- 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.
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- 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.
- Subject has a previous medical documentation of positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (HCV).
- Patients with current known history of diabetes
- 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.
- Subject has a history or presence of alcoholism or drug abuse within the 2 years prior to Visit 0.
- 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.
- 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.
- Participation in another clinical trial within 30 days prior to the Screening Visit or during this study.
- History of mental illness that would preclude completion of the study
- Subject has history of anaphylactic reactions.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
Robert Galiano, MD FACS, 312-695-6022, rgaliano@nmh.org
Jing Liu, MD, 312-695-3908, jiliu@nmh.org
About this study
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
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.
Read the 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.
- Conditions
- Wounds and Injuries
- Being tested
- AR/101, Placebo
- Keywords
- skin regeneration, re-epithelialization, split thickness wounds, Abdominoplasty
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AR/101Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: AR/101 |
| 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of days, per wound within a subject, from treatment initiation to complete re epithelialization.
Measured: Up to 21 days
Secondary outcomes (3)
The number of days, per wound within a subject, from treatment initiation to reach 50% re-epithelialization
Measured: Up to 21 days
The number of days, per wound within a subject, from treatment initiation to reach 75% re-epithelialization
Measured: Up to 21 days
Percentage of split thickness wounds with full re-epithelialization
Measured: Up to 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionJun 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wounds and InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arava Bio Tech Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cato Research
- Responsible party
- Sponsor
- Investigators
- Robert Galiano, MD FACS, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02602184
- Sponsor's protocol ID
- NU-AR-2015-01
- Status last verified
- Nov 2015
- First submitted
- 8 Nov 2015
- Last updated
- 19 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02602184
- Acronym / sponsor ID
- NU-AR-2015-01
- Conditions
- Wounds and Injuries
- Keywords
- skin regeneration, re-epithelialization, split thickness wounds, Abdominoplasty
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Arava Bio Tech Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Cato Research
- Study start
- Nov 2015
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 11 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AR/101 | Experimental | Drug: AR/101Topically 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. |
| Placebo | Placebo comparator | Drug: PlaceboTopically 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. |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- 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.
Key exclusion criteria (19 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AR/101 | Drug | AR/101 |
| Placebo | Drug | Placebo |
Primary outcome
The number of days, per wound within a subject, from treatment initiation to complete re epithelialization.
Time frame: Up to 21 days
3 secondary outcomes
The number of days, per wound within a subject, from treatment initiation to reach 50% re-epithelialization
Time frame: Up to 21 days
The number of days, per wound within a subject, from treatment initiation to reach 75% re-epithelialization
Time frame: Up to 21 days
Percentage of split thickness wounds with full re-epithelialization
Time frame: Up to 21 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Galiano, MD FACS principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AR/101 in people with Wounds and Injuries, run by Arava Bio Tech Ltd. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tamar Tennenbaum, MD, Ph.D (972-9-8343015, tamar@arava-bio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of days, per wound within a subject, from treatment initiation to complete re epithelialization. (time frame: Up to 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2016.