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ScarPhase 2NCT05501327

Dose Regimen Study of SLI-F06 in Healthy Volunteers

A Phase 2 study testing SLI-F06 in people with Scar and Wound Healing, run by Scarless Laboratories, Inc. at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Scar, Wound Healing
What is being tested?
SLI-F06
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
2 sitesUnited States
Study dates
25 Jul 2022to 25 Oct 2024
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 23Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Elisabeth J Leeflang, MD contact

213-788-2128

ELeeflang@scarlesslabs.com

United States2 sites, 2 recruiting

  • DermResearch

    Austin, Texas, 78759

    Jewel Medley, 512-349-9889, jewel@vial.com

    Janet Dubois, MD

    Recruiting

  • California Dermatology & Clinical Research Institute

    Encinitas, California, 92024

    Tiffany Robb, 760-203-3839, trobb@cdcrinstitute.com

    Stacy Smith, MD

    Recruiting

Other trials in United States

About this study

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

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

Read the 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
Being tested
SLI-F06
Keywords
Scar, Scar Appearance, Wound Healing
Medical subject headings
Cicatrix

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SLI-F06Drug

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

Study groups in NCT05501327
Study groupRoleWhat they receive
Cohort AExperimentalInjection 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)
Receives: Drug: SLI-F06
Cohort BExperimentalInjection 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)
Receives: Drug: SLI-F06
Cohort CExperimentalInjection 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
Receives: Drug: SLI-F06

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Months 1,3,6 and possibly 9

Secondary outcomes (2)

  1. Patient and Observer Scar Assessment Scale (POSAS) Observer Scale

    Established scar scale with observer rating of 1 (normal skin) to 10 (worst scar imaginable) for 6 different parameters (vascularity, pigmentation, thickness, relief, pliability, surface area) and overall opinion rated on the same 1-10 scale. The sum of these scores is added for a total value with a higher number being worse.

    Measured: Months 1,3,6 and possibly 9

  2. Scarless Labs Patient Scale

    Exploratory scale for subjects to assess different scar parameters, with 0 being no difference in pain or itching of the scar compared with normal skin and -3 being severe or worse. Patients then select a face on a modified Wong-Baker scale for their overall opinion of the scar.

    Measured: Months 1,3,6 and possibly 9

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2022
  2. Study start25 Jul 2022
  3. Primary completion25 Jul 2024 (estimated)
  4. Study completion25 Oct 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05501327
Sponsor's protocol ID
SLI-F06-002
Status last verified
Jul 2023
First submitted
11 Aug 2022
Last updated
27 Jul 2023
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SLI-F06 in people with Scar and Wound Healing, run by Scarless Laboratories, Inc. at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Elisabeth J Leeflang, MD (213-788-2128, ELeeflang@scarlesslabs.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Scarless Labs Observer Scale (time frame: Months 1,3,6 and possibly 9). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05501327.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.

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