Evaluating SLI-F06 for improving scar appearance in healthy volunteers
A Randomized, Within Subject Controlled, Dose Regimen Study of SLI-F06 in Healthy Volunteers for Improvement in Scar Appearance
This study is testing a new treatment called SLI-F06 to see if it can improve the appearance of scars in healthy volunteers aged 18 to 65.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Scarless Laboratories, Inc. Industry-sponsored |
| Locations | 2 sites (Encinitas, California and 1 other locations) |
| Trial ID | NCT05501327 on ClinicalTrials.gov |
What this trial studies
This Phase IIa interventional study assesses the safety and efficacy of SLI-F06 in improving scar appearance through a multi-center, double-blind approach. Healthy volunteers aged 18 to 65 will undergo small punch biopsies on their upper and lower backs, with excisions randomized to receive either SLI-F06 or a vehicle control. Participants will be divided into three cohorts, each receiving different dosing regimens, and scars will be evaluated for improvement over a follow-up period of 6-9 months. The study aims to determine the optimal dose regimen for enhancing wound healing and scar appearance.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18 to 65 with a BMI between 18.5 and 30.
Not a fit: Patients with a history of hypertrophic or keloid scarring or those with significant back abnormalities will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a new treatment option for improving the appearance of scars.
How similar studies have performed: While similar approaches have been explored, this specific dosing regimen for SLI-F06 is novel and has not been previously tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
1. Healthy subjects, male or female, ages 18 to 65
2. Subjects with a Body Mass Index (BMI) 18.5-30 and at least 40 kg
3. 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.
4. Be able to follow study instructions and likely to complete all required visits.
5. 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:
1. Female subjects who are pregnant, breast-feeding, or of childbearing potential and not practicing reliable birth control methods
2. Subjects who were previously treated with SLI-F06
3. Subjects with evidence of hypertrophic or keloid scarring
4. Subjects with obvious back abnormalities (e.g., severe scoliosis)
5. Subjects with tattoos or previous scars in the study areas
6. Subjects who are poor surgical candidates
1. Active disease that could interfere with or limit wound healing (e.g., diabetes, anemia, renal disease, hepatic disease, cardiac disease, or immune system disorders)
2. History of clinically significant bleeding disorder or coagulation disorders
3. Use of any tobacco/inhaled nicotine products including vaping within 12 months.
7. Subjects with evidence of skin infection or rash on the back
8. Subjects with history of active or uncontrolled skin disease (e.g., psoriasis, eczema, rosacea, vitiligo, skin cancer) that could interfere with the study or interpretation of the study outcomes
9. Subjects with a history of clinically significant allergies, especially drug hypersensitivity to lignocaine or allergy to adhesive surgical dressings
10. Subjects with any clinically significant abnormality following review of pre-study laboratory data and full physical examination
11. Subjects who are taking or have taken known anticoagulants:
1. Blood thinners (e.g., coumadin, rivaroxaban, apixaban) within 2 months prior to day 0
2. Others such as aspirin or aspirin containing products, Non-steroidal anti-inflammatory drugs (NSAIDs), vitamin E, fish oil within 14 days prior to day 0.
12. Subjects taking systemic or topical steroids within 4 weeks of Day 0
13. Subjects with excessive alcohol use, defined as \>28 units of alcohol per week (1unit = 8 g alcohol, 1shot spirits, half- pint beer, or 5 oz wine)
14. Subjects who have evidence of drug abuse
15. Subjects who are known to have or had serum hepatitis or who are carriers of the hepatitis B surface antigen per medical history
16. Subjects with a history of poor or delayed wound healing (e.g., prior wound dehiscence, chronic wound, leg ulcer)
17. Subjects treated with an investigational drug or device within 30 days prior to day 0
18. Any condition or situation that, in the investigator's opinion, may put the subject at significant risk, or may significantly interfere with the subject's participation in the study
Where this trial is running
Encinitas, California and 1 other locations
- California Dermatology & Clinical Research Institute — Encinitas, California, United States (Recruiting)
- DermResearch — Austin, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Elisabeth J Leeflang, MD
- Email: ELeeflang@scarlesslabs.com
- Phone: 213-788-2128
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.