Dose Regimen Study of SLI-F06 in Healthy Volunteers

Status Recruiting

Clinical Trial Summary

Multi-center, dose-regimen, double-blind study evaluating the safety and efficacy of 4 doses of SLI-F06 compared with vehicle for improvement in scar appearance

Clinical Trial Description

The is a Phase IIa dose-regimen study of small punch biopsy scars created on the upper and lower back of healthy patients. All excisions will be randomized to treatment with vehicle or 4 doses of SLI-F06 drug product. Patients will be divided into 3 cohorts, with Cohort B receiving the same doses as Cohort A but daily for a total of 5 days. Cohort C will receive up to twice the concentration of Cohort A potentially divided into 2 doses, with both cohorts treated only on treatment Day 0. Scars will be assessed for improvement by both the investigator and the patient at follow-up visits over 6-9 months. Duration of study-approximately 7-10 months. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05501327
Study type	Interventional
Source	Scarless Laboratories, Inc.
Contact	Elisabeth J Leeflang, MD
Phone	213-788-2128
Email	ELeeflang@scarlesslabs.com
Status	Recruiting
Phase	Phase 2
Start date	July 25, 2022
Completion date	October 25, 2024

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