Efficacy of Topical TolaSure on Acute Induced Wounds in Healthy Participants

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

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.

Study Overview

• Status: Completed
• Conditions: Wound Healing
• Intervention / Treatment: Drug: TolaSure Topical Gel; Drug: Topical Vehicle Gel

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami
  • Texas
    • College Station, Texas, United States, 77845
      • J&S Studies

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 5 Percent TolaSure Topical Gel; 5%(w/w) TolaSure Gel	Drug: 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.; Other Names: Active Ingredient BM-3103
Placebo Comparator: Topical Vehicle Gel; Vehicle Gel	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.; Other Names: TolaSure Vehicle Gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Area Reduction after Four Weeks	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.	Week 4
Wound Pain Control	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	Day 2 and 7, then weekly until wound closure (estimated 8 weeks)
Quality of Healing	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.	End of study (estimated 8 weeks)
Cutaneous Tolerability	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)	Day 1, 2, and 7, then weekly until wound closure (estimated 8 weeks)
Blood and Urine Chemistries	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.	Screening, Day 2 and 7, then weekly until wound closure (estimated 8 weeks)

Collaborators and Investigators

• Sponsor: BioMendics, LLC
• Collaborators: Symbio, LLC

Study record dates

Study Major Dates

• Study Start (Actual): August 26, 2019
• Primary Completion (Actual): April 22, 2020
• Study Completion (Actual): April 22, 2020

Study Registration Dates

• First Submitted: September 11, 2019
• First Submitted That Met QC Criteria: September 11, 2019
• First Posted (Actual): September 12, 2019

Study Record Updates

• Last Update Posted (Actual): June 24, 2021
• Last Update Submitted That Met QC Criteria: June 18, 2021
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Biopsy; Skin; Healthy Participants; Dermal
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: SYM 2019-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No