Actively Recruiting
A Randomized, Within Subject Controlled, Dose Regimen Study of SLI-F06 in Healthy Volunteers for Improvement in Scar Appearance
Led by Scarless Laboratories, Inc. · Updated on 2023-07-27
30
Participants Needed
2
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effects of different doses of SLI-F06 on the appearance of scars formed after small punch biopsies on the upper and lower back of healthy adults. This Phase IIa study involves healthy volunteers aged 18 to 65 and aims to compare four doses of the drug with a placebo vehicle to see which improves scar appearance. The study is randomized and double-blind to ensure objective results and is sponsored by Scarless Laboratories, Inc. Participants are divided into three groups receiving different dosing regimens: Cohort A gets a single injection of SLI-F06 or vehicle right after wound closure on Day 0; Cohort B receives daily injections for five days starting on Day 0; and Cohort C receives higher doses either once or twice on Day 0. The drug is injected at the edges of the biopsy wounds to evaluate how dosing frequency and concentration affect scar healing. During the approximately 7 to 10 months study period, scars will be regularly assessed by both the study team and participants at months 1, 3, 6, and possibly 9 using standardized scar rating scales. Participants will attend follow-up visits for evaluations and safety monitoring. The main outcome is the change in scar appearance measured by the Scarless Labs Observer Scale, with additional patient and observer scar assessments to track improvements over time.
CONDITIONS
Brief Title
Dose Regimen Study of SLI-F06 in Healthy Volunteers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy male or female adults aged 18 to 65
- Body Mass Index (BMI) between 18.5 and 30 and weighing at least 40 kg
- Symmetrical right and left scapular lines with at least 12 cm between them
- Ability to follow study instructions and complete all visits
- Signed informed consent form including photographic and video release
You will not qualify if you...
- Females who are pregnant, breastfeeding, or of childbearing potential not using reliable birth control
- Previous treatment with SLI-F06
- Presence of hypertrophic or keloid scars
- Obvious back abnormalities such as severe scoliosis
- Tattoos or previous scars in the study areas
- Poor candidates for surgery
- Active diseases affecting wound healing (e.g., diabetes, anemia, kidney or liver disease, heart disease, immune disorders)
- History of significant bleeding or coagulation disorders
- Use of tobacco or inhaled nicotine products in past 12 months
- Skin infection or rash on the back
- Active or uncontrolled skin diseases (e.g., psoriasis, eczema, rosacea, vitiligo, skin cancer)
- Significant allergies, especially to lignocaine or surgical dressings
- Abnormal lab results or physical exam findings
- Use of blood thinners within 2 months or aspirin/NSAIDs/vitamin E/fish oil within 14 days prior to Day 0
- Use of systemic or topical steroids within 4 weeks of Day 0
- Excessive alcohol use (>28 units per week)
- Evidence of drug abuse
- History or carrier status of hepatitis B
- History of poor or delayed wound healing
- Treatment with investigational drugs or devices within 30 days prior to Day 0
- Any condition that may pose significant risk or interfere with study participation
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 to 5 days depending on cohort
Participants receive injections of SLI-F06 or control at the wound edges after punch biopsy excision on the upper and lower back. Treatment schedules vary by cohort, including single or multiple doses on Day 0 and up to Day 4.
1 to 5 visits depending on cohort
Duration - 6 to 9 months
Participants return for scar assessments by both investigators and themselves over several months to monitor scar improvement.
Visits at approximately Months 1, 3, 6, and possibly 9
Trial Site Locations
Total: 2 locations
1
California Dermatology & Clinical Research Institute
Encinitas, California, United States, 92024
Actively Recruiting
2
DermResearch
Austin, Texas, United States, 78759
Actively Recruiting
Research Team
E
Elisabeth J Leeflang, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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