Actively Recruiting

Phase 2
Age: 18Years - 65Years
All Genders
Healthy Volunteers
NCT05501327

Dose Regimen Study of SLI-F06 in Healthy Volunteers

Led by Scarless Laboratories, Inc. · Updated on 2023-07-27

30

Participants Needed

2

Research Sites

117 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Dose Regimen Study of SLI-F06 in Healthy Volunteers

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Healthy males or females aged 18 to 65
  • Body Mass Index (BMI) between 18.5 and 30 and minimum weight of 40 kg
  • Symmetrical scapular lines on right and left sides with at least 12 cm distance between them
  • Ability to follow study instructions and complete all visits
  • Signed informed consent form including photographic and video release
Not Eligible

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 scarring
  • Obvious back abnormalities such as severe scoliosis
  • Tattoos or previous scars in the study areas
  • Poor surgical candidates
  • Active diseases that affect wound healing (e.g., diabetes, anemia, kidney, liver, heart, or immune disorders)
  • History of significant bleeding or coagulation disorders
  • Use of tobacco or nicotine products within 12 months
  • Skin infection or rash on the back
  • Active or uncontrolled skin diseases (e.g., psoriasis, eczema, rosacea, vitiligo, skin cancer) that may interfere with the study
  • Clinically significant allergies, especially to lignocaine or surgical dressings
  • Significant abnormalities found in pre-study lab tests or physical exam
  • Use of blood thinners within 2 months prior to Day 0
  • Use of aspirin, NSAIDs, vitamin E, or fish oil within 14 days prior to Day 0
  • Use of systemic or topical steroids within 4 weeks prior to Day 0
  • Excessive alcohol use (>28 units per week)
  • Evidence of drug abuse
  • History or carrier of hepatitis B
  • History of poor or delayed wound healing
  • Use of investigational drugs or devices within 30 days prior to Day 0
  • Any condition that may pose significant risk or interfere with study participation as judged by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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Research Team

E

Elisabeth J Leeflang, MD

CONTACT

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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