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

January 29, 2019 updated by: BioMendics, LLC

A Phase One, Single Center, Open-Label, University of Miami Medical Center, 14 Day Study Evaluating the Safety, Cutaneous Tolerability, and Efficacy of TolaSure Topical Gel in Healthy Volunteers

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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
  • Pregnancy test
  • Drug screen

Exclusion Criteria:

  • Acute or chronic skin disorders (e.g. acne, psoriasis, dermatitis)
  • Prone to keloids or hypertrophic scarring
  • Topical or systemic antibiotics within 4 weeks of study enrollment
  • Subjects with mental illnesses
  • Diagnosed with Diabetes Type I/II
  • 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
  • Cancer diagnosis in the last year
  • 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 5 Percent TolaSure Topical Gel
TolaSure topical gel is applied to skin punch biopsies daily over the course of 2 weeks.
Active Comparator: 1.5 Percent TolaSure Topical Gel
TolaSure topical gel is applied to skin punch biopsies daily over the course of 2 weeks.
Active Comparator: 0.5 Percent TolaSure Topical Gel
TolaSure topical gel is applied to skin punch biopsies daily over the course of 2 weeks.
Placebo Comparator: Topical Vehicle Gel
TolaSure topical gel is applied to skin punch biopsies daily over the course of 2 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood and Urine Chemistries
Time Frame: Day 1, 2, 7 and 14.
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.
Day 1, 2, 7 and 14.
Cutaneous Tolerability
Time Frame: Day 1, 2, 7 and 14.

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, 7 and 14.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wound Closure
Time Frame: Day 1, 2, 7 and 14.
Imaging of punch biopsies to monitor for healing and wound closure including measurement of changes in wound area (mm^2) over time will be assessed using digital imaging and analyzed using wound tracing techniques followed by the use of appropriate statistics.
Day 1, 2, 7 and 14.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Collaborators

Investigators

  • Study Director: Karen McGuire, PhD, BioMendics, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 16, 2018

Primary Completion (Actual)

December 12, 2018

Study Completion (Actual)

December 12, 2018

Study Registration Dates

First Submitted

July 10, 2018

First Submitted That Met QC Criteria

August 6, 2018

First Posted (Actual)

August 8, 2018

Study Record Updates

Last Update Posted (Actual)

January 30, 2019

Last Update Submitted That Met QC Criteria

January 29, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 20180394

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Wound Healing

Clinical Trials on TolaSure Topical Gel

Subscribe