Randomized Dose Regimen Study of SLI-F06 to Improve Scar Appearance in Healthy Adults

What this Trial Is About

Researchers are evaluating the safety and effects of different doses of SLI-F06 on the appearance of scars formed after small punch biopsies on the upper and lower back of healthy adults. This Phase IIa study involves healthy volunteers aged 18 to 65 and aims to compare four doses of the drug with a placebo vehicle to see which improves scar appearance. The study is randomized and double-blind to ensure objective results and is sponsored by Scarless Laboratories, Inc. Participants are divided into three groups receiving different dosing regimens Cohort A gets a single injection of SLI-F06 or vehicle right after wound closure on Day 0 Cohort B receives daily injections for five days starting on Day 0 and Cohort C receives higher doses either once or twice on Day 0. The drug is injected at the edges of the biopsy wounds to evaluate how dosing frequency and concentration affect scar healing. During the approximately 7 to 10 months study period, scars will be regularly assessed by both the study team and participants at months 1, 3, 6, and possibly 9 using standardized scar rating scales. Participants will attend follow-up visits for evaluations and safety monitoring. The main outcome is the change in scar appearance measured by the Scarless Labs Observer Scale, with additional patient and observer scar assessments to track improvements over time.

Dose Regimen Study of SLI-F06 in Healthy Volunteers