Clinical trial NCT04088357: Efficacy of Topical TolaSure on Acute Induced Wounds in Healthy Participants
Official title: A Phase II, Closed Label, Randomized, Double Blind Study for the Treatment of Acute Induced Wounds With TolaSure Gel, 5% w/w in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Wound Healing
Keywords: Healthy Participants
Skin
Dermal
Biopsy
Lead sponsor: BioMendics, LLC
Sponsor class: INDUSTRY
Collaborators: name: Symbio, LLC
First posted: 2019-09-12
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 healthy participants. Safety, cutaneous tolerability, wound pain control, and quality of healing will also be assessed. A total of 80 healthy volunteers, males and females ages 18 years or older, will be enrolled. Subjects will be monitored for safety and efficacy until wound closure (estimation about 8 weeks) following topical administration of TolaSure.


Eligibility criteria: Inclusion Criteria:

* Healthy Males and Females \> 18 years of age
* Health history review
* Physical exam
* Blood and urine clinical chemistries
* Negative pregnancy test

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Accelerated Wound Closure
timeFrame: Day 1, 2, and 7, then weekly until closure (estimated 8 weeks)
Secondary outcomes:
measure: Percent Area Reduction after Four Weeks
timeFrame: Week 4
measure: Wound Pain Control
timeFrame: Day 2 and 7, then weekly until wound closure (estimated 8 weeks)
measure: Quality of Healing
timeFrame: End of study (estimated 8 weeks)
measure: Cutaneous Tolerability
timeFrame: Day 1, 2, and 7, then weekly until wound closure (estimated 8 weeks)
measure: Blood and Urine Chemistries
timeFrame: Screening, Day 2 and 7, then weekly until wound closure (estimated 8 weeks)
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
city: College Station
country: United States
facility: J&S Studies
state: Texas
Study officials:
References: