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

NCT ID: NCT03620175

Last Updated: 2019-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-16
• Study Completion Date: 2018-12-12

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

5 Percent TolaSure Topical Gel

Group Type: ACTIVE_COMPARATOR

TolaSure Topical Gel

Intervention Type: DRUG

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

1.5 Percent TolaSure Topical Gel

Group Type: ACTIVE_COMPARATOR

TolaSure Topical Gel

Intervention Type: DRUG

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

0.5 Percent TolaSure Topical Gel

Group Type: ACTIVE_COMPARATOR

TolaSure Topical Gel

Intervention Type: DRUG

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

Topical Vehicle Gel

Group Type: PLACEBO_COMPARATOR

TolaSure Topical Gel

Intervention Type: DRUG

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

Interventions

TolaSure Topical Gel

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Miami

OTHER

Sponsor Role: collaborator

BioMendics, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karen McGuire, PhD

Role: STUDY_DIRECTOR

BioMendics, LLC

Locations

University of Miami

Miami, Florida, United States

Countries

United States

Other Identifiers

20180394

Identifier Type: -

Identifier Source: org_study_id