Safety and Efficacy of SLI-F06 in Wound Healing and Scar Appearance

NCT03880058 | Completed Phase 1 Results FDA Drug

• 1 other identifier: SLI-C40-001
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 3

Brief Summary

Multicenter, double-blind study comparing SLI-F06 to vehicle formulation buffer for the improvement in scar appearance and wound strength in routine surgical excisions, as well as post-operative abdominoplasty scar appearance.

Conditions

Scars

Outcome Measures

Primary Outcomes (2)

• Patient and Observer Scar Assessment Scale (POSAS) - PI Assessment

  POSAS is an established scale for assessing scar by both the patient and the observer. The overall opinion of the scar is reported on a scale of 1-10, with 1 being normal skin and 10 being the worst scar. Comparisons between treatment groups for efficacy analyses are based on 95% confidence intervals (CI) calculated using mixed models with treatment group as a fixed effect and subject as a random effect to account for multiple observations (i.e., scars) within subject.

  Post-excision at Month 3

• Patient and Observer Scar Assessment Scale (POSAS) - PI Assessment

  POSAS is an established scale for assessing scar by both the patient and the observer. The overall opinion of the scar is reported on a scale of 1-10, with 1 being normal skin and 10 being the worst scar. Comparisons between treatment groups for efficacy analyses are based on 95% confidence intervals (CI) calculated using mixed models with treatment group as a fixed effect and subject as a random effect to account for multiple observations (i.e., scars) within subject.

  Post-abdominoplasty at Month 12

Study Arms (2)

SLI-F06

ACTIVE COMPARATOR

Drug Product under investigation

Drug: SLI-F06

Formulation Buffer

PLACEBO COMPARATOR

Placebo

Drug: Formulation buffer

Interventions

SLI-F06 DRUG

Active treatment

Also known as: F06-C40

SLI-F06

Formulation buffer DRUG

Placebo treatment

Also known as: Placebo, vehicle

Formulation Buffer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Outpatient, male or female of any race, 18 years of age or older. Female subjects of childbearing potential must have a negative urine pregnancy test (UPT) at Visit 1a and 1b and practice a reliable method of contraception throughout the study.
• Seeking or scheduled for standard elective abdominoplasty.
• Willing to undergo directed excisions and follow-up prior to abdominoplasty and to undergo all follow-up visits after abdominoplasty.
• Willing to undergo directed excisions under local anesthetic
• 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 Release Form and HIPAA, prior to any study-related procedures being performed.

You may not qualify if:

• Female subjects that are pregnant, breast-feeding, or of childbearing potential and not practicing reliable birth control.
• Known hypersensitivity or previous allergic reaction to any constituent of the investigational product (IP).
• History of diabetes mellitus or a Hemoglobin (HgB) A1C greater than 5.7 percent.
• Morbid obesity (i.e., BMI \>40).
• History of prior abdominal surgery.
• History of abdominal liposuction, cryolipolysis, focused ultrasound or other fat reduction procedures in or near the anterior abdomen within 12 months of baseline.
• History of poor or delayed wound healing such as a prior wound dehiscence, chronic wound or leg ulcer.
• History of or evidence of a genetic collagen disorder such as Ehlers-Danlos syndrome.
• Operating Physician unable to design an abdominoplasty incision area of at least 25 cm wide by 12 cm tall at the center of the fusiform.
• The presence of any abnormality of the skin within the area of the proposed abdominoplasty that, in the opinion of the Principal Investigator (PI), could interfere with the excision process or grading of the resultant surgical scar.
• Use of any restricted concomitant medications/procedures or tobacco/inhaled nicotine products within a restricted time period.
• Allergy to or intolerance of local anesthetics.
• Medical or psychiatric conditions that may increase the risk associated with study participation or may interfere with interpretation of study results or compliance of the subject and, in the opinion of the PI, would make the subject inappropriate for study entry.
• Any personal, familial, employment or financial situation that could impede the subject's ability to attend all study visits and successfully complete the entire clinical study.
• Clinically significant alcohol or drug abuse, or history of poor cooperation or unreliability.

Sponsors & Collaborators

• Scarless Laboratories, Inc.: lead
• ethica Clinical Research Inc.: collaborator

Study Sites (3)

Site 1

Chicago, Illinois, 60611-2950, United States

Location

Site 2

St Louis, Missouri, 63110, United States

Location

Site 3

Bala-Cynwyd, Pennsylvania, 19004, United States

Location

MeSH Terms

Conditions

Cicatrix

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Elisabeth Leeflang
• Organization: Scarless Labs Inc.

Clin_Info@scarlesslabs.com

213-788-2128

Study Officials

• Robert D. Galiano, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2019
• First Posted: March 19, 2019
• Study Start: March 3, 2019
• Primary Completion: May 18, 2021
• Study Completion: May 18, 2021
• Last Updated: April 18, 2023
• Results First Posted: April 18, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)