Efficacy of Topical TolaSure on Acute Induced Wounds in Healthy Participants

Wound Healing Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04088357
• Other study ID #: SYM 2019-01
• Status: Completed
• Phase: Phase 2
• Start date: August 26, 2019
• Est. completion date: April 22, 2020

Study information

• Verified date: June 2020
• Source: BioMendics, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: April 22, 2020
• Est. primary completion date: April 22, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Wound Healing
• Wounds and Injuries

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	J&S Studies	College Station	Texas
United States	University of Miami	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
BioMendics, LLC	Symbio, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)