Efficacy of Topical TolaSure on Acute Induced Wounds in Healthy Participants

NCT ID: NCT04088357

Last Updated: 2021-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-26
• Study Completion Date: 2020-04-22

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.

Conditions

Wound Healing

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

5 Percent TolaSure Topical Gel

5%(w/w) TolaSure Gel

Group Type: ACTIVE_COMPARATOR

TolaSure Topical Gel

Intervention Type: DRUG

TolaSure topical gel is applied to skin punch biopsies daily for the first seven consecutive days, then three times a week, defined as every two to three days, until closure.

Topical Vehicle Gel

Vehicle Gel

Group Type: PLACEBO_COMPARATOR

Topical Vehicle Gel

Intervention Type: DRUG

TolaSure Vehicle Gel is applied topically to skin punch biopsies daily for the first seven consecutive days, then three times a week, defined as every two to three days, until closure.

Interventions

TolaSure Topical Gel

TolaSure topical gel is applied to skin punch biopsies daily for the first seven consecutive days, then three times a week, defined as every two to three days, until closure.

Intervention Type: DRUG

Topical Vehicle Gel

TolaSure Vehicle Gel is applied topically to skin punch biopsies daily for the first seven consecutive days, then three times a week, defined as every two to three days, until closure.

Intervention Type: DRUG

Other Intervention Names

Active Ingredient BM-3103; TolaSure Vehicle Gel

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Symbio, LLC

INDUSTRY

Sponsor Role: collaborator

BioMendics, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Miami

Miami, Florida, United States

J&S Studies

College Station, Texas, United States

Countries

United States

Other Identifiers

SYM 2019-01

Identifier Type: -

Identifier Source: org_study_id