Recruiting
Phase 2

SLI-F06

Sponsor:

Scarless Laboratories, Inc.

Code:

NCT05501327

Conditions

Scar

Wound Healing

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

SLI-F06

Study Details

Brief 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

Conditions

Scar

Wound Healing

Study ID

NCT05501327

Start date

Jul 25, 2022

Status verified date

Jul, 2023

Completion date

Oct 25, 2024

Anticipated

Primary completion date

Jul 25, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cohort A

Injection of SLI-F06 on Treatment Day 0, immediately after wound closure:

  • Formulation buffer (control)
  • 3.75 mg SLI-F06 total dose per wound (1X)
  • 7.5 mg SLI-F06 total dose per wound (2X)
  • 15 mg SLI-F06 total dose per wound (4X)

experimental: Cohort B

Injection of SLI-F06 on Treatment Day 0, immediately after wound closure and on Days 1, 2, 3, 4:

  • Formulation buffer (control)
  • 3.75 mg SLI-F06 total dose per wound (1X)
  • 7.5 mg SLI-F06 total dose per wound (2X)
  • 15 mg SLI-F06 total dose per wound (4X)

experimental: Cohort C

Injection of SLI-F06 on Treatment Day 0, immediately after wound closure and then 3 hours after for wounds dosed twice:

  • Formulation buffer (control) once
  • 7.5 mg SLI-F06 total dose per wound (2X) once
  • 3.75 mg SLI-F06 dose per wound (1X) twice, total dose 7.5 mg
  • 7.5 mg SLI-F06 total dose per wound (2X), total dose 15 mg

Interventions

SLI-F06

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

Primary outcome measure

  • Change in Scarless Labs Observer Scale [ Time Frame: Months 1,3,6 and possibly 9 ]

Central Contacts and Locations

Central contacts

Locations

California Dermatology & Clinical Research Institute

Recruiting

Encinitas, California, United States, 92024

Contacts

Principal Investigator:

Stacy Smith, MD

DermResearch

Recruiting

Austin, Texas, United States, 78759

Contacts

Principal Investigator:

Janet Dubois, MD

More Information

Sponsor

Scarless Laboratories, Inc.

Last update posted

Jul 27, 2023

Last verified

Jul, 2023

Keywords

  • Scar
  • Scar Appearance
  • Wound Healing

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Scarless Laboratories, Inc. on 2023-07-27.