Dose Regimen Study of SLI-F06 in Healthy Volunteers

Launched by SCARLESS LABORATORIES, INC. · Aug 11, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called SLI-F06, which is being tested to see if it can improve the appearance of scars and help with wound healing. The study is currently looking for healthy volunteers between the ages of 18 to 65 who meet certain criteria, such as having a specific body weight range and being able to complete all study visits. Participants will be randomly assigned to receive one of four doses of SLI-F06 or a placebo (a treatment with no active ingredients), and neither the participants nor the researchers will know who receives which treatment.

If you decide to participate, you can expect to attend several visits where you will receive the treatment and undergo assessments to evaluate its effects on your scars. It’s important to note that there are some eligibility restrictions. For instance, women who are pregnant or breastfeeding cannot participate, and individuals with certain medical conditions or those who have used specific medications recently may also be excluded. This trial aims to gather important information about the safety and effectiveness of SLI-F06, which could help improve scar treatments in the future.

Gender

ALL

Eligibility 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