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Completed

NCT Number: NCT03620175

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

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.

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Key information

Conditions

Wound Healing

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Miami

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TolaSure Topical Gel

Drug

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

Primary outcomes

  1. 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.

  2. 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)

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

BioMendics, LLC

Industry

Collaborators

  • University of Miami

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 8, 2018
Registry last updated
Jan 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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