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Efficacy of Topical TolaSure on Acute Induced Wounds in Healthy Participants

NCT04088357 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2021-06-24

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • Symbio, LLC

    collaborator INDUSTRY

  • BioMendics, LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-08-26
Primary Completion
2020-04-22
Completion
2020-04-22
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04088357 on ClinicalTrials.gov