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

Primary Purpose

Scars

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
SLI-F06
Formulation buffer
Sponsored by
Scarless Laboratories, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scars

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 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.
  2. Seeking or scheduled for standard elective abdominoplasty.
  3. Willing to undergo directed excisions and follow-up prior to abdominoplasty and to undergo all follow-up visits after abdominoplasty.
  4. Willing to undergo directed excisions under local anesthetic
  5. Be able to follow study instructions and likely to complete all required visits.
  6. 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.

Exclusion Criteria:

  1. Female subjects that are pregnant, breast-feeding, or of childbearing potential and not practicing reliable birth control.
  2. Known hypersensitivity or previous allergic reaction to any constituent of the investigational product (IP).
  3. History of diabetes mellitus or a Hemoglobin (HgB) A1C greater than 5.7 percent.
  4. Morbid obesity (i.e., BMI >40).
  5. History of prior abdominal surgery.
  6. History of abdominal liposuction, cryolipolysis, focused ultrasound or other fat reduction procedures in or near the anterior abdomen within 12 months of baseline.
  7. History of poor or delayed wound healing such as a prior wound dehiscence, chronic wound or leg ulcer.
  8. History of or evidence of a genetic collagen disorder such as Ehlers-Danlos syndrome.
  9. 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.
  10. 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.
  11. Use of any restricted concomitant medications/procedures or tobacco/inhaled nicotine products within a restricted time period.
  12. Allergy to or intolerance of local anesthetics.
  13. 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.
  14. 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.
  15. Clinically significant alcohol or drug abuse, or history of poor cooperation or unreliability.
  16. Exposure to any other investigational drug/device within 30 days prior to study entry.

Sites / Locations

  • Site 1
  • Site 2
  • Site 3

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

SLI-F06

Formulation Buffer

Arm Description

Drug Product under investigation

Placebo

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
March 5, 2019
Last Updated
March 24, 2023
Sponsor
Scarless Laboratories, Inc.
Collaborators
ethica Clinical Research Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03880058
Brief Title
Safety and Efficacy of SLI-F06 in Wound Healing and Scar Appearance
Official Title
Safety and Efficacy of SLI-F06 in Wound Healing and Scar Appearance in Pre-Abdominoplasty Surgical Excisions and Post-Operative Scar Appearance In Subjects Undergoing Abdominoplasty
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
March 3, 2019 (Actual)
Primary Completion Date
May 18, 2021 (Actual)
Study Completion Date
May 18, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Scarless Laboratories, Inc.
Collaborators
ethica Clinical Research Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The study is divided into 2 parts where Part A is a Phase I safety/proof of concept study of small scars pre-abdominoplasty, and Part B is a Phase IIa study of post-abdominoplasty scars. In Part A of the study, subjects will have their abdominoplasty site mapped to accommodate a series of excisions depending on pannus size. All excisions to be treated with SLI-F06 will be on one side of the mapped area (i.e., left side or right side) and vehicle treated excisions will be on the other side of the mapped area. At time of abdominoplasty the excision site will be harvested and processed. In Part B of the study, subjects who complete Part A will be randomly assigned to receive injections of SLI-F06 along one half (left or right) of the abdominoplasty incision and control injections along the other half. The subject will undergo routine wound care and will attend study follow-up visits following abdominoplasty. The entire incision will be treated post-operatively in precisely the same manner. Duration of study-approximately 26 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scars

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SLI-F06
Arm Type
Active Comparator
Arm Description
Drug Product under investigation
Arm Title
Formulation Buffer
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
SLI-F06
Other Intervention Name(s)
F06-C40
Intervention Description
Active treatment
Intervention Type
Drug
Intervention Name(s)
Formulation buffer
Other Intervention Name(s)
Placebo, vehicle
Intervention Description
Placebo treatment
Primary Outcome Measure Information:
Title
Patient and Observer Scar Assessment Scale (POSAS) - PI Assessment
Description
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.
Time Frame
Post-excision at Month 3
Title
Patient and Observer Scar Assessment Scale (POSAS) - PI Assessment
Description
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.
Time Frame
Post-abdominoplasty at Month 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. Exposure to any other investigational drug/device within 30 days prior to study entry.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert D. Galiano, MD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Site 1
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-2950
Country
United States
Facility Name
Site 2
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Site 3
City
Bala-Cynwyd
State/Province
Pennsylvania
ZIP/Postal Code
19004
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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