Dose Regimen Study of SLI-F06 in Healthy Volunteers

Part of paid clinical trials in Encinitas, California.

Sponsor
Scarless Laboratories, Inc.
Study ID
NCT05501327
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

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

Study Details

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

Key Dates

Start date
Jul 25, 2022
Status verified
Jul 2023
Primary completion
Jul 25, 2024
Completion
Oct 25, 2024

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

Primary Outcome Measure

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

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
California Dermatology & Clinical Research InstituteEncinitasCalifornia92024
Tiffany Robb
[email protected]
760-203-3839
Stacy Smith, MD (PRINCIPAL_INVESTIGATOR)
DermResearchAustinTexas78759
Jewel Medley
[email protected]
512-349-9889
Janet Dubois, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Encinitas, CA

By research site
California Dermatology & Clinical Research Institute· Encinitas, CADermResearch· Austin, TX

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