RecruitingPhase 2NCT05501327

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

Sponsor

Scarless Laboratories, Inc.

Enrollment

30 participants

Start Date

Jul 25, 2022

Study Type

INTERVENTIONAL

Conditions

Scar Wound Healing

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

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria5

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 Criteria23

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
Use of any tobacco/inhaled nicotine products including vaping within 12 months.
Subjects with evidence of skin infection or rash on the back
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
Subjects with a history of clinically significant allergies, especially drug hypersensitivity to lignocaine or allergy to adhesive surgical dressings
Subjects with any clinically significant abnormality following review of pre-study laboratory data and full physical examination
Subjects who are taking or have taken known anticoagulants:
Blood thinners (e.g., coumadin, rivaroxaban, apixaban) within 2 months prior to day 0
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.
Subjects taking systemic or topical steroids within 4 weeks of Day 0
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)
Subjects who have evidence of drug abuse
Subjects who are known to have or had serum hepatitis or who are carriers of the hepatitis B surface antigen per medical history
Subjects with a history of poor or delayed wound healing (e.g., prior wound dehiscence, chronic wound, leg ulcer)
Subjects treated with an investigational drug or device within 30 days prior to day 0
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