SLI-F06 for Scarring

Recruiting at 1 trial location

Overseen By Elisabeth J Leeflang, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Scarless Laboratories, Inc.

Must not be taking: Anticoagulants, NSAIDs, Steroids

Disqualifiers: Pregnancy, Diabetes, Skin disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 5 days

30 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a medication called SLI-F06 to see if it can improve the appearance of scars. Healthy individuals with small biopsy scars on their backs will receive different doses of the medication. The goal is to find out if SLI-F06 helps scars heal better and look less noticeable over time.

Will I have to stop taking my current medications?

The trial requires that you stop taking blood thinners like coumadin, rivaroxaban, and apixaban at least 2 months before starting, and aspirin, NSAIDs, vitamin E, and fish oil at least 14 days before. You also need to stop taking systemic or topical steroids 4 weeks before the trial.

What data supports the effectiveness of the treatment SLI-F06 for scarring?

Research shows that various laser treatments, like fractional CO2 lasers, have been effective in improving the appearance of scars by reducing their size and irregularity. These treatments have been shown to improve the quality of life for patients with different types of scars, suggesting that similar approaches could be beneficial for scarring. ^{1 2 3 4 5}

Research Team

Elisabeth J Leeflang, MD

Principal Investigator

Scarless Laboratories, Inc.

Eligibility Criteria

Healthy men and women, aged 18-65 with a BMI of 18.5-30, can join this trial if they have symmetrical scapular lines and are able to follow the study's instructions. They must not have used SLI-F06 before or any blood thinners recently, be free from significant health issues that affect healing, not pregnant or breastfeeding without reliable birth control, no excessive alcohol use or tobacco products in the past year.

Inclusion Criteria

Be able to follow study instructions and likely to complete all required visits

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

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

I have thick or keloid scars.

I have a severe spine condition like scoliosis.

Use of any tobacco/inhaled nicotine products including vaping within 12 months

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive injections of SLI-F06 or control immediately after wound closure, with varying regimens across cohorts

5 days

Daily visits for Cohort B, single visit for Cohorts A and C

Follow-up

Participants are monitored for scar improvement using various assessment scales

6-9 months

Visits at Months 1, 3, 6, and possibly 9

Treatment Details

Interventions

• SLI-F06

Trial Overview The study is testing four different doses of SLI-F06 against a placebo to see which one is better at improving scar appearance after surgery. It's conducted across multiple centers where participants are randomly assigned to receive either the drug or placebo without knowing which one they're getting (double-blind).

Participant Groups

Group I: Cohort C Experimental Treatment 1 Intervention

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 II: Cohort B Experimental Treatment 1 Intervention

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 III: Cohort A Experimental Treatment 1 Intervention

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)

Who Is Running the Clinical Trial?

Scarless Laboratories, Inc.

Lead Sponsor

Trials

2

Recruited

50+

References

1. United States pubmed.ncbi.nlm.nih.gov

Evaluation of clinical results, histological architecture, and collagen expression following treatment of mature burn scars with a fractional carbon dioxide laser. [2016]

2. England pubmed.ncbi.nlm.nih.gov

Objective evaluation of the efficacy of a non-ablative fractional 1565 nm laser for the treatment of deliberate self-harm scars. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

The efficacy and safety of 10,600-nm carbon dioxide fractional laser for acne scars in Asian patients. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Efficacy of Combined Intense Pulsed Light (IPL) With Fractional CO2 -Laser Ablation in the Treatment of Large Hypertrophic Scars: A Prospective, Randomized Control Trial. [2020]

5. Germany pubmed.ncbi.nlm.nih.gov

Identification of steroid sensitive responders versus non-responders in the treatment of keloid disease. [2013]