Efficacy of Topical TolaSure on Acute Induced Wounds in Healthy Participants

NCT04088357 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: SYM 2019-01
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 2

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

Keywords

Healthy Participants; Skin; Dermal; Biopsy

Outcome Measures

Primary Outcomes (1)

• Accelerated Wound Closure

  Time-to-closure will be calculated by the number of days from biopsy to wound closure. Wound closure (changes in wound area (mm\^2) over time) will be determined by the digital imaging platform software with Principal Investigator confirmation.

  Day 1, 2, and 7, then weekly until closure (estimated 8 weeks)

Secondary Outcomes (5)

• Percent Area Reduction after Four Weeks

  Week 4

• Wound Pain Control

  Day 2 and 7, then weekly until wound closure (estimated 8 weeks)

• Quality of Healing

  End of study (estimated 8 weeks)

• Cutaneous Tolerability

  Day 1, 2, and 7, then weekly until wound closure (estimated 8 weeks)

• Blood and Urine Chemistries

  Screening, Day 2 and 7, then weekly until wound closure (estimated 8 weeks)

Study Arms (2)

5 Percent TolaSure Topical Gel

ACTIVE COMPARATOR

5%(w/w) TolaSure Gel

Drug: TolaSure Topical Gel

Topical Vehicle Gel

PLACEBO COMPARATOR

Vehicle Gel

Drug: Topical Vehicle Gel

Interventions

TolaSure Topical Gel 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.

Also known as: Active Ingredient BM-3103

5 Percent TolaSure Topical Gel

Topical Vehicle Gel 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.

Also known as: TolaSure Vehicle Gel

Topical Vehicle Gel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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;

Sponsors & Collaborators

• BioMendics, LLC: lead
• Symbio, LLC: collaborator

Study Sites (2)

University of Miami

Miami, Florida, 33136, United States

Location

J&S Studies

College Station, Texas, 77845, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2019
• First Posted: September 12, 2019
• Study Start: August 26, 2019
• Primary Completion: April 22, 2020
• Study Completion: April 22, 2020
• Last Updated: June 24, 2021

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)