- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03620175
Safety and Efficacy of Topical TolaSure on Skin Punch Biopsies in Healthy Participants
A Phase One, Single Center, Open-Label, University of Miami Medical Center, 14 Day Study Evaluating the Safety, Cutaneous Tolerability, and Efficacy of TolaSure Topical Gel in Healthy Volunteers
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Florida
-
Miami, Florida, United States, 33136
- University of Miami
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy Males and Females > 18 years of age
- Health history review
- Physical exam
- Blood and urine clinical chemistries
- Pregnancy test
- Drug screen
Exclusion Criteria:
- Acute or chronic skin disorders (e.g. acne, psoriasis, dermatitis)
- Prone to keloids or hypertrophic scarring
- Topical or systemic antibiotics within 4 weeks of study enrollment
- Subjects with mental illnesses
- Diagnosed with Diabetes Type I/II
- Surgery within the previous 3 months (except for minor cosmetic or dental procedures)
- History of severe vitamin or mineral deficiency
- History of drug or alcohol abuse (as defined by the Investigator)
- Smoking/Vaping
- HIV/AIDS
- Consistently taking steroids and/or non-steroidal anti-inflammatory drugs
- Cancer diagnosis in the last year
- Currently receiving chemotherapy or radiation
- Women who are pregnant, nursing or planning a pregnancy
- Hyper- or hypo-pigmentation, or tattoos in the area where they will place the test fields
- Symptoms of a clinically significant illness in the four weeks before treatment application that may influence the outcome of the study
- Treatment with any investigational agent within one month before treatment application for this trial
- Unwilling or unable to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject's return for follow-up visits on schedule
- Other unspecified reasons that, in the opinion of the Investigator, make the subject unsuitable for enrollment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 5 Percent TolaSure Topical Gel
|
TolaSure topical gel is applied to skin punch biopsies daily over the course of 2 weeks.
|
Active Comparator: 1.5 Percent TolaSure Topical Gel
|
TolaSure topical gel is applied to skin punch biopsies daily over the course of 2 weeks.
|
Active Comparator: 0.5 Percent TolaSure Topical Gel
|
TolaSure topical gel is applied to skin punch biopsies daily over the course of 2 weeks.
|
Placebo Comparator: Topical Vehicle Gel
|
TolaSure topical gel is applied to skin punch biopsies daily over the course of 2 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood and Urine Chemistries
Time Frame: Day 1, 2, 7 and 14.
|
Absolute values and changes over time of clinical chemistries including; Absolute values and changes over time of clinical blood and urine chemistries including; Hematology and Coagulation, Coagulation, Serum Chemistry, and Urinalysis.
Blood and urine analytes are measured on a per mL basis.
|
Day 1, 2, 7 and 14.
|
Cutaneous Tolerability
Time Frame: Day 1, 2, 7 and 14.
|
Cutaneous tolerability will include an evaluation of erythema and edema following the modified Draize scoring system. Draize scores will be recorded and changes from baseline Draize scores will be monitored over the course of the time frame. Draize Scoring System. Erythema: 0-No Erythema, 1-Slight Erythema, 2-Well Defined Erythema, 3- Moderate or Severe Erythema, 4- Severe Erythema or slight eschar formation. Edema: 0- No Edema, 1- Very Slight Edema(barely perceptible), 2-Slight Edema (well defined edges), 3-Moderate Edema (raised >1mm), 4- Severe Edema (raised >1mm and extending beyond the area of exposure) |
Day 1, 2, 7 and 14.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Wound Closure
Time Frame: Day 1, 2, 7 and 14.
|
Imaging of punch biopsies to monitor for healing and wound closure including measurement of changes in wound area (mm^2) over time will be assessed using digital imaging and analyzed using wound tracing techniques followed by the use of appropriate statistics.
|
Day 1, 2, 7 and 14.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Karen McGuire, PhD, BioMendics, LLC
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 20180394
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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