AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

Dose Regimen Study of SLI-F06 in Healthy Volunteers

RecruitingPhase 2Ages 18 Years - 65 YearsAllScarless Laboratories, Inc.
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
๐Ÿ’Š

What it tests

  • SLI-F06
๐Ÿ“

Where

2 sites
California Dermatology & Clinical Research Institute
Encinitas, United States
DermResearch
Austin, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy