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

NCT03620175 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: 20180394
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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

Keywords

Healthy Participants; Skin; Dermal; Biopsy

Outcome Measures

Primary Outcomes (2)

• Blood and Urine Chemistries

  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

  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 Outcomes (1)

• Wound Closure

  Day 1, 2, 7 and 14.

Study Arms (4)

5 Percent TolaSure Topical Gel

ACTIVE COMPARATOR

Drug: TolaSure Topical Gel

1.5 Percent TolaSure Topical Gel

ACTIVE COMPARATOR

Drug: TolaSure Topical Gel

0.5 Percent TolaSure Topical Gel

ACTIVE COMPARATOR

Drug: TolaSure Topical Gel

Topical Vehicle Gel

PLACEBO COMPARATOR

Drug: TolaSure Topical Gel

Interventions

TolaSure Topical Gel DRUG

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

0.5 Percent TolaSure Topical Gel; 1.5 Percent TolaSure Topical Gel; 5 Percent TolaSure Topical Gel; Topical Vehicle Gel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy Males and Females \> 18 years of age
• Health history review
• Physical exam
• Blood and urine clinical chemistries
• Pregnancy test
• Drug screen

You may not qualify if:

• 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

Sponsors & Collaborators

• BioMendics, LLC: lead
• University of Miami: collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

Study Officials

• Karen McGuire, PhD

  BioMendics, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes Assessor is blinded to treatment groups and vehicle control.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Each patient receives each of the 4 treatment arms. It is closest to a single-subject design where each participant serves as their own control. The placement of treatments on each of the 4 wounds is randomized and assessed by a blinded outcomes assessor.

Study Record Dates

• First Submitted: July 10, 2018
• First Posted: August 8, 2018
• Study Start: July 16, 2018
• Primary Completion: December 12, 2018
• Study Completion: December 12, 2018
• Last Updated: January 30, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)