Ireland
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Recruiting Phase 2

Dose Regimen Study of SLI-F06 in Healthy Volunteers

NCT05501327 · tracked via the Priya Life Science USA tracker
Sponsor
Scarless Laboratories, Inc
Phase
Phase 2
Started
2022-07-25
Last updated
2023-07-27

Condition(s) studied

ScarWound Healing

Investigational drug(s) / intervention(s)

SLI-F06

SLI-F06: Skin injection of SLI-F06 at each wound edge after closure of punch biopsy excision.

Study 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • Change in Scarless Labs Observer Scale — Months 1,3,6 and possibly 9
    Exploratory scale for observer to assess different scar parameters, including Surface Area, Elevation / Depression, Relief, Thickness, Pliability, Vascularity and Pigmentation. The observer then makes an Overall global assessment (scale 0 to -3) of the scar based on the clinical assessment of the scar parameters. All parameters are assessed on a scale of 0-3 (except pigmentation, -3 \[hypo\] to +3 \[hyper\]), where 0 correlates to a scar that is indistinguishable from normal skin with greater deviation from 0 correlating with more severe scar. The observer creates a forced rank between scars on the upper and lower back based on best (1) to worst (4) cosmetically.

Trial sites (2)

FacilityCityRegionStatus
California Dermatology & Clinical Research Institute Encinitas California Recruiting
DermResearch Austin Texas Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05501327 on ClinicalTrials.gov ↗ ← All trials in the USA