RecruitingPhase 2

Dose Regimen Study of SLI-F06 in Healthy Volunteers

United States30 participantsStarted 2022-07-25

Plain-language 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

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. Healthy subjects, male or female, ages 18 to 65
✓. Subjects with a Body Mass Index (BMI) 18.5-30 and at least 40 kg
✓. Subjects with symmetrically located right and left scapular lines relative to the midline, and at least 12 cm distance between the right and left scapular lines.
✓. Be able to follow study instructions and likely to complete all required visits.
✓. Sign the Institutional Review Board (IRB)-approved informed consent form (ICF, which includes the Photographic and Video Release Form) prior to any study-related procedures being performed.

Exclusion criteria

✕. Female subjects who are pregnant, breast-feeding, or of childbearing potential and not practicing reliable birth control methods
✕. Subjects who were previously treated with SLI-F06
✕. Subjects with evidence of hypertrophic or keloid scarring
✕. Subjects with obvious back abnormalities (e.g., severe scoliosis)
✕. Subjects with tattoos or previous scars in the study areas
✕. Subjects who are poor surgical candidates
✕. Active disease that could interfere with or limit wound healing (e.g., diabetes, anemia, renal disease, hepatic disease, cardiac disease, or immune system disorders)
✕. History of clinically significant bleeding disorder or coagulation disorders

What they're measuring

Change in Scarless Labs Observer Scale

Timeframe: Months 1,3,6 and possibly 9

Trial details

NCT IDNCT05501327

SponsorScarless Laboratories, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-07-25

Contact for this trial

Elisabeth J Leeflang, MD

213-788-2128 ELeeflang@scarlesslabs.com

View on ClinicalTrials.gov More Scar trials