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Safety and Efficacy of Topical TolaSure on Skin Punch Biopsies in Healthy Participants

NCT03620175 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2019-01-30

No results posted yet for this study

Summary

TolaSure is a topical gel for the promotion of wound healing. This phase I study will assess the safety, tolerability and clinical effect of TolaSure when applied to skin wounds created by punch biopsy in healthy participants. A total of 26 healthy volunteers, males and females ages 18 years or older, will be enrolled. Subjects will monitored for safety and efficacy over the course of 2 weeks following daily topical administration of TolaSure.

Conditions

  • Wound Healing

Interventions

DRUG

TolaSure Topical Gel

TolaSure topical gel is applied to skin punch biopsies daily over the course of 2 weeks.

Sponsors & Collaborators

  • University of Miami

    collaborator OTHER

  • BioMendics, LLC

    lead INDUSTRY

Principal Investigators

  • Karen McGuire, PhD · BioMendics, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-07-16
Primary Completion
2018-12-12
Completion
2018-12-12
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 NCT03620175 on ClinicalTrials.gov