NCT05501327

Dose Regimen Study of SLI-F06 in Healthy Volunteers

A Randomized, Within Subject Controlled, Dose Regimen Study of SLI-F06 in Healthy Volunteers for Improvement in Scar Appearance

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Scarless Laboratories, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Detailed 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.

Conditions

• Scar
• Wound Healing

Interventions

Type	Name	Description
DRUG	SLI-F06	Skin injection of SLI-F06 at each wound edge after closure of punch biopsy excision.

Timeline

• Start date: 2022-07-25
• Primary completion: 2024-07-25
• Completion: 2024-10-25
• First posted: 2022-08-15
• Last updated: 2023-07-27

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study