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Completed

NCT Number: NCT04088357

Efficacy of Topical TolaSure on Acute Induced Wounds in Healthy Participants

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.

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Key information

Conditions

Wound Healing

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Miami, Miami, Florida, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Active Ingredient BM-3103

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.

Other names: TolaSure Vehicle Gel

Primary outcomes

  1. Accelerated Wound Closure

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

    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.

Secondary outcomes

  1. Percent Area Reduction after Four Weeks

    Time frame: Week 4

    Wound area measurements (mm^2) will be calculated at week 4 by using a digital imaging. A percent reduction in area at week 4 will be calculated by comparing the initial area of the biopsy at Day 1 to the week 4 biopsy area.

  2. Wound Pain Control

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

    Wound-related pain or discomfort will be assessed, using the Visual Analog Scale (VAS) for Pain, for each individual wound site as pain at rest followed by pain to touch.

    The VAS Pain is a continuous scale comprised of a horizontal line, 10 centimeters (100 mm) in length.

    Pain will be defined per the following scale:

    None - 0-4 mm; Mild - 5-44 mm: Moderate - 45-74; Severe - 75-100 mm

  3. Quality of Healing

    Time frame: End of study (estimated 8 weeks)

    Patient and Observer Scar Assessment Scale (POSAS) version 2.0 will be used to assess the quality of healing of each biopsy site at the end of the study once both wounds are closed.

  4. Cutaneous Tolerability

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

    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)

  5. Blood and Urine Chemistries

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

    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.

Sponsors and collaborators

Lead sponsor

BioMendics, LLC

Industry

Collaborators

  • Symbio, LLC

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 12, 2019
Registry last updated
Jun 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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