Dose Regimen Study of SLI-F06 in Healthy Volunteers

Official title

A Randomized, Within Subject Controlled, Dose Regimen Study of SLI-F06 in Healthy Volunteers for Improvement in Scar Appearance

Overview

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.

Interventions

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

Primary outcome measures

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

Secondary outcome measures (2)

• Patient and Observer Scar Assessment Scale (POSAS) Observer Scale [Time frame: Months 1,3,6 and possibly 9]
• Scarless Labs Patient Scale [Time frame: Months 1,3,6 and possibly 9]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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
• 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.
• Subjects taking systemic or topical steroids within 4 weeks of Day 0
• 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)
• Subjects who have evidence of drug abuse
• Subjects who are known to have or had serum hepatitis or who are carriers of the hepatitis B surface antigen per medical history
• Subjects with a history of poor or delayed wound healing (e.g., prior wound dehiscence, chronic wound, leg ulcer)
• Subjects treated with an investigational drug or device within 30 days prior to day 0
• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

United States · 2 centers

• California Dermatology & Clinical Research Institute — Encinitas
• DermResearch — Austin

Identifiers

NCT: NCT05501327 · SLI-F06-002

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗