Dose Regimen Study of SLI-F06 in Healthy Volunteers

NCT05501327 | Recruiting Phase 2 FDA Drug

• 1 other identifier: SLI-F06-002
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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

Keywords

Scar; Scar Appearance; Wound Healing

Outcome Measures

Primary Outcomes (1)

• Change in Scarless Labs Observer Scale

  Exploratory scale for observer to assess different scar parameters, including Surface Area, Elevation / Depression, Relief, Thickness, Pliability, Vascularity and Pigmentation. The observer then makes an Overall global assessment (scale 0 to -3) of the scar based on the clinical assessment of the scar parameters. All parameters are assessed on a scale of 0-3 (except pigmentation, -3 \[hypo\] to +3 \[hyper\]), where 0 correlates to a scar that is indistinguishable from normal skin with greater deviation from 0 correlating with more severe scar. The observer creates a forced rank between scars on the upper and lower back based on best (1) to worst (4) cosmetically.

  Months 1,3,6 and possibly 9

Secondary Outcomes (2)

• Patient and Observer Scar Assessment Scale (POSAS) Observer Scale

  Months 1,3,6 and possibly 9

• Scarless Labs Patient Scale

  Months 1,3,6 and possibly 9

Study Arms (3)

Cohort A

EXPERIMENTAL

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)

Drug: SLI-F06

Cohort B

EXPERIMENTAL

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)

Drug: SLI-F06

Cohort C

EXPERIMENTAL

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

Drug: SLI-F06

Interventions

SLI-F06 DRUG

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

Cohort A; Cohort B; Cohort C

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy subjects, male or female, ages 18 to 65
• Subjects with a Body Mass Index (BMI) 18.5-30 and at least 40 kg
• 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.
• Be able to follow study instructions and likely to complete all required visits.
• 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.

You may not qualify if:

• Female subjects who are pregnant, breast-feeding, or of childbearing potential and not practicing reliable birth control methods
• Subjects who were previously treated with SLI-F06
• Subjects with evidence of hypertrophic or keloid scarring
• Subjects with obvious back abnormalities (e.g., severe scoliosis)
• Subjects with tattoos or previous scars in the study areas
• Subjects who are poor surgical candidates
• Active disease that could interfere with or limit wound healing (e.g., diabetes, anemia, renal disease, hepatic disease, cardiac disease, or immune system disorders)
• History of clinically significant bleeding disorder or coagulation disorders
• Use of any tobacco/inhaled nicotine products including vaping within 12 months.
• Subjects with evidence of skin infection or rash on the back
• 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
• Subjects with a history of clinically significant allergies, especially drug hypersensitivity to lignocaine or allergy to adhesive surgical dressings
• Subjects with any clinically significant abnormality following review of pre-study laboratory data and full physical examination
• Subjects who are taking or have taken known anticoagulants:
• Blood thinners (e.g., coumadin, rivaroxaban, apixaban) within 2 months prior to day 0

Sponsors & Collaborators

• Scarless Laboratories, Inc.: lead

Study Sites (2)

California Dermatology & Clinical Research Institute

Encinitas, California, 92024, United States

RECRUITING

DermResearch

Austin, Texas, 78759, United States

RECRUITING

MeSH Terms

Conditions

Cicatrix

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Elisabeth J Leeflang, MD

  Scarless Laboratories, Inc.

  STUDY DIRECTOR

Central Study Contacts

Elisabeth J Leeflang, MD

CONTACT

213-788-2128; ELeeflang@scarlesslabs.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2022
• First Posted: August 15, 2022
• Study Start: July 25, 2022
• Primary Completion: July 25, 2024
• Study Completion: October 25, 2024
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)