Status:
COMPLETED
Efficacy of Topical TolaSure on Acute Induced Wounds in Healthy Participants
Lead Sponsor:
BioMendics, LLC
Collaborating Sponsors:
Symbio, LLC
Conditions:
Wound Healing
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
TolaSure is a topical gel for the promotion of accelerated wound healing. This phase II study will primarily assess the efficacy of TolaSure when applied to skin wounds created by punch biopsy in heal...
Eligibility Criteria
Inclusion
- Healthy Males and Females \> 18 years of age
- Health history review
- Physical exam
- Blood and urine clinical chemistries
- Negative pregnancy test
Exclusion
- Acute or chronic skin disorders (e.g. psoriasis);
- Acne or dermatitis at the test site;
- Prone to keloids or hypertrophic scarring;
- Topical or systemic antibiotics within 4 weeks of study enrollment;
- Subjects with known severe mental illness which, in the investigator's opinion, may prevent informed consent or interfere with the subject's ability to comply with study protocol procedures;
- Diagnosed with Diabetes Type I/II or glucose results indicative of prediabetic condition;
- Morbidly obese with a Body Mass Index (BMI) ≥ 40;
- 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. Subjects may use NSAIDs on an as needed basis with no more than 7 days of consecutive use;
- Cancer diagnosis in the last 5 years;
- 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.
Key Trial Info
Start Date :
August 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 22 2020
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT04088357
Start Date
August 26 2019
End Date
April 22 2020
Last Update
June 24 2021
Active Locations (2)
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1
University of Miami
Miami, Florida, United States, 33136
2
J&S Studies
College Station, Texas, United States, 77845