SLI-F06 for Scarring

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called SLI-F06, an experimental therapy, to determine if it can improve the appearance of scars after wound healing. Researchers aim to assess the safety and effectiveness of different doses of SLI-F06 compared to a placebo, an inactive substance. Participants will receive injections of SLI-F06 or a placebo immediately after wound closure, with some receiving additional doses on subsequent days. This trial targets healthy individuals without back tattoos or scars and who do not smoke or use nicotine products. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that SLI-F06 is likely to be safe for humans?

Research has shown that SLI-F06 has been tested in earlier studies with people. In these trials, participants generally tolerated it well, with most experiencing no problems. So far, researchers have not reported any major safety issues. Some studies involved injecting SLI-F06 into small wounds to observe its effect on scar healing. Participants in these studies did not experience serious side effects from the treatment. While the treatment remains under study, current evidence suggests it is safe for people. Those considering joining a trial may find this information reassuring regarding safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for scarring?

Researchers are excited about SLI-F06 for scarring because it offers a potentially faster and more effective approach to minimizing scars compared to existing treatments like silicone sheets or corticosteroid injections. Unlike most current options that can take weeks or months to show results, SLI-F06 is injected immediately after wound closure, potentially acting more quickly to influence the healing process. Additionally, SLI-F06 provides various dosing options, allowing for tailored treatment: some doses are applied once, while others are applied multiple times to enhance effectiveness. This flexibility and immediacy offer a novel way to tackle scarring, potentially improving outcomes for patients.

What evidence suggests that this trial's treatments could be effective for scarring?

Research has shown that SLI-F06 can significantly enhance wound healing. In animal studies, wounds treated with SLI-F06 became stronger and more resilient than untreated ones. This treatment promotes fibroblasts, crucial cells for skin repair, to move and function more effectively. It also aids in forming better collagen, a key component of healing, by speeding up recovery and strengthening scar tissue. These promising animal results suggest that SLI-F06 might also improve scar appearance in humans. Participants in this trial will receive varying dosages of SLI-F06 to assess its effectiveness in humans. ^{1 2 4 6 7}

Who Is on the Research Team?

Elisabeth J Leeflang, MD

Principal Investigator

Scarless Laboratories, Inc.

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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).

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05501327

Dose Regimen Study of SLI-F06 in Healthy Volunteers 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 ...

2. reporter.nih.gov reporter.nih.gov/search/Q16CRa99xUK-bwp7-IaBhg/project-details/10689794

Novel peptide-impregnated hydrogel as a wound healing ... Pig efficacy data showed a significant wound tensile strength increase in wounds treated with HA-SLI-F06 compared to controls. To expedite and derisk technical, ...

3. sbir.gov sbir.gov/portfolio/297908

Company SLI-F06 promotes fibroblast migration, contraction, and collagen cross-linking to accelerate wound tensile strength reestablishment while HA provides a “bridge” ...

4. science.org science.org/doi/10.1126/sciadv.ade7007

Breakthrough treatments for accelerated wound healing A fibromodulin (FMOD)–based amino acid peptide sequence, SLI-F06 (Scarless Laboratories), was found to stimulate fibroblast and endothelial cell ...

5. withpower.com withpower.com/trial/phase-2-scarring-6-2022-e2fad

SLI-F06 for Scarring · Info for Participants 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 ...

6. scholars.northwestern.edu scholars.northwestern.edu/en/projects/protsli-c40-001-safety-and-efficacy-of-sli-f06-in-wound-healing-a-4

Safety and Efficacy of SLI-F06 in Wound Healing and Scar ... Prot#SLI-C40-001: Safety and Efficacy of SLI-F06 in Wound Healing and Scar Appearance in Pre-Abdominoplasty Surgical Excisions and ...

7. synapse.patsnap.com synapse.patsnap.com/drug/c3e620afc4d44ed2bd3a4507292bd052

SLI-F06 - Drug Targets, Indications, Patents Safety and Efficacy of SLI-F06 in Wound Healing and Scar Appearance in Pre-Abdominoplasty Surgical Excisions and Post-Operative Scar Appearance In Subjects ...