Dose Regimen Study of SLI-F06 in Healthy Volunteers

NCT ID: NCT05501327

Last Updated: 2023-07-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-25
• Study Completion Date: 2024-10-25

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

Detailed Description

The is a Phase IIa dose-regimen study of small punch biopsy scars created on the upper and lower back of healthy patients. All excisions will be randomized to treatment with vehicle or 4 doses of SLI-F06 drug product. Patients will be divided into 3 cohorts, with Cohort B receiving the same doses as Cohort A but daily for a total of 5 days. Cohort C will receive up to twice the concentration of Cohort A potentially divided into 2 doses, with both cohorts treated only on treatment Day 0. Scars will be assessed for improvement by both the investigator and the patient at follow-up visits over 6-9 months.

Duration of study-approximately 7-10 months.

Conditions

Scar; Wound Healing

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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)

Group Type: EXPERIMENTAL

SLI-F06

Intervention Type: DRUG

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

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)

Group Type: EXPERIMENTAL

SLI-F06

Intervention Type: DRUG

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

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

Group Type: EXPERIMENTAL

SLI-F06

Intervention Type: DRUG

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

Interventions

SLI-F06

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Scarless Laboratories, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elisabeth J Leeflang, MD

Role: STUDY_DIRECTOR

Scarless Laboratories, Inc.

Locations

California Dermatology & Clinical Research Institute

Encinitas, California, United States

Site Status: RECRUITING

DermResearch

Austin, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Elisabeth J Leeflang, MD

Role: CONTACT

ELeeflang@scarlesslabs.com

213-788-2128

Facility Contacts

Tiffany Robb

Role: primary

trobb@cdcrinstitute.com

760-203-3839

Jewel Medley

Role: primary

jewel@vial.com

512-349-9889

Other Identifiers

SLI-F06-002

Identifier Type: -

Identifier Source: org_study_id