TolaSure is a topical gel for the promotion of accelerated wound healing. This phase II study will primarily assess the efficacy of TolaSure when applied to skin wounds created by punch biopsy in healthy participants. Safety, cutaneous tolerability, wound pain control, and quality of healing will also be assessed. A total of 80 healthy volunteers, males and females ages 18 years or older, will be enrolled. Subjects will be monitored for safety and efficacy until wound closure (estimation about 8 weeks) following topical administration of TolaSure.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
72
TolaSure topical gel is applied to skin punch biopsies daily for the first seven consecutive days, then three times a week, defined as every two to three days, until closure.
TolaSure Vehicle Gel is applied topically to skin punch biopsies daily for the first seven consecutive days, then three times a week, defined as every two to three days, until closure.
University of Miami
Miami, Florida, United States
J&S Studies
College Station, Texas, United States
Accelerated Wound Closure
Time-to-closure will be calculated by the number of days from biopsy to wound closure. Wound closure (changes in wound area (mm\^2) over time) will be determined by the digital imaging platform software with Principal Investigator confirmation.
Time frame: Day 1, 2, and 7, then weekly until closure (estimated 8 weeks)
Percent Area Reduction after Four Weeks
Wound area measurements (mm\^2) will be calculated at week 4 by using a digital imaging. A percent reduction in area at week 4 will be calculated by comparing the initial area of the biopsy at Day 1 to the week 4 biopsy area.
Time frame: Week 4
Wound Pain Control
Wound-related pain or discomfort will be assessed, using the Visual Analog Scale (VAS) for Pain, for each individual wound site as pain at rest followed by pain to touch. The VAS Pain is a continuous scale comprised of a horizontal line, 10 centimeters (100 mm) in length. Pain will be defined per the following scale: None - 0-4 mm; Mild - 5-44 mm: Moderate - 45-74; Severe - 75-100 mm
Time frame: Day 2 and 7, then weekly until wound closure (estimated 8 weeks)
Quality of Healing
Patient and Observer Scar Assessment Scale (POSAS) version 2.0 will be used to assess the quality of healing of each biopsy site at the end of the study once both wounds are closed.
Time frame: End of study (estimated 8 weeks)
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)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Day 1, 2, and 7, then weekly until wound closure (estimated 8 weeks)
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.
Time frame: Screening, Day 2 and 7, then weekly until wound closure (estimated 8 weeks)