Clinical trial NCT03620175: Safety and Efficacy of Topical TolaSure on Skin Punch Biopsies in Healthy Participants
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Wound Healing
Keywords: Healthy Participants
Skin
Dermal
Biopsy
Lead sponsor: BioMendics, LLC
Sponsor class: INDUSTRY
Collaborators: name: University of Miami
First posted: 2018-08-08
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Blood and Urine Chemistries
timeFrame: Day 1, 2, 7 and 14.
measure: Cutaneous Tolerability
timeFrame: Day 1, 2, 7 and 14.
Secondary outcomes:
measure: Wound Closure
timeFrame: Day 1, 2, 7 and 14.
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: BioMendics, LLC
name: Karen McGuire, PhD
role: STUDY_DIRECTOR
References: