CompletedNCT03880058Updated Apr 18, 2023Results posted

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

A Phase 1/2 interventional study of SLI-F06 and Formulation buffer in Scars, sponsored by Scarless Laboratories, Inc.. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-18.

Sponsored by Scarless Laboratories, Inc. · Phase 1/2, Interventional, and Treatment

Phase: Phase 1/2
Study type: Interventional
Enrollment: 22
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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.

Read the 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.

Conditions studied

Scars

Browse trials for

Cicatrix 307

In context

Cicatrix

307 studies on the registry are indexed under Cicatrix; 50 are open to participants now.

This study's enrollment of 22 is below the median of 39 across 251 interventional studies indexed under Cicatrix.

Browse Cicatrix studies →

Lead sponsor

Scarless Laboratories, Inc. is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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.

Study design

Phase: Phase 1 / Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Care provider, Investigator)
Enrollment: 22 participants (actual)

Study arms

Active comparator
SLI-F06
Drug Product under investigation
Drug: SLI-F06
Placebo comparator
Formulation Buffer
Placebo
Drug: Formulation buffer

Interventions

DrugSLI-F06
Active treatment
Also known as: F06-C40
DrugFormulation buffer
Placebo treatment
Also known as: Placebo, vehicle

What researchers measure

Primary outcomes

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.
Time frame: 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.
Time frame: Post-abdominoplasty at Month 12

Results

Posted Apr 18, 2023

Participant flow

Part A: Pre-abdominoplasty Injections

Participant flow — Part A: Pre-abdominoplasty Injections
Milestone	All Study Participants
Started	22
Received sli-f06	22
Received control	22
Completed	22
Not completed	0

Part B: Abdominoplasty Injections

Participant flow — Part B: Abdominoplasty Injections
Milestone	All Study Participants
Started	21
Received sli-f06	21
Received control	21
Completed	21
Not completed	0

Outcome measures

PrimaryPatient 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.

Time frame:: Post-excision at Month 3
Reported as:: Mean · score on a scale

Patient and Observer Scar Assessment Scale (POSAS) - PI Assessment
score on a scale	SLI-F06	Formulation Buffer
Patient and Observer Scar Assessment Scale (POSAS) - PI Assessment	4.4 ± 1.7	4.5 ± 1.7

PrimaryPatient and Observer Scar Assessment Scale (POSAS) - PI Assessment

Time frame:: Post-abdominoplasty at Month 12
Reported as:: Mean · score on a scale

Patient and Observer Scar Assessment Scale (POSAS) - PI Assessment
score on a scale	SLI-F06	Formulation Buffer
Patient and Observer Scar Assessment Scale (POSAS) - PI Assessment	1.6 ± 1.7	1.7 ± 1.7

Adverse events

Collected over Subjects were assessed at Visit 4a (Day 29), Visit 5a (Day 57 - Group 2 only), Visit 6a (Day 85 - Group 1 only), Visits 3b-12b (M1-3, 6, 9, 12, 15, 18, 21 and 24 at study exit).. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
SLI-F06	0/22 (0%)	3/22 (13.6%)	14/22 (63.6%)
Formulation Buffer	0/22 (0%)	3/22 (13.6%)	14/22 (63.6%)

Most frequent serious events

Most frequent serious events
Event	SLI-F06	Formulation Buffer
Pulmonary embolismVascular disorders	1/22	1/22
Abortion spontaneousPregnancy, puerperium and perinatal conditions	1/22	1/22
NephrolithiasisRenal and urinary disorders	1/22	1/22

Most frequent other events

Showing 10 of 37

Most frequent other events
Event	SLI-F06	Formulation Buffer
CellulitisInfections and infestations	2/22	2/22
NasopharyngitisInfections and infestations	2/22	2/22
Seroma drainageSurgical and medical procedures	1/22	1/22
Umbilical herniaGastrointestinal disorders	1/22	1/22
AlopeciaSkin and subcutaneous tissue disorders	1/22	1/22
Skin necrosisSkin and subcutaneous tissue disorders	1/22	1/22
SeromaInjury, poisoning and procedural complications	1/22	1/22
PyrexiaGeneral disorders	1/22	1/22
HeadacheNervous system disorders	1/22	1/22
Aortic arteriosclerosisVascular disorders	1/22	1/22

Baseline characteristics

In Part A, there were 140 treated scars and 140 control scars per subject for a total of 280. In Part B, there was one abdominoplasty incision per patient, with the left or right side receiving treatment or control. Each subject served as their own control.

Age, Continuous
Age, Continuous(years)	All Study Participants
Mean	43.4 ± 10.2

Sex: Female, Male
Sex: Female, Male(Participants)	All Study Participants
Female	21
Male	1

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	All Study Participants
Hispanic or Latino	4
Not Hispanic or Latino	18
Unknown or Not Reported	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	All Study Participants
American Indian or Alaska Native	0
Asian	0
Native Hawaiian or Other Pacific Islander	0
Black or African American	6
White	16
More than one race	0
Unknown or Not Reported	0

BMI
BMI(kg/m^2)	All Study Participants
Mean	32 ± 5.4

Study locations

3 sites

Site 1
Chicago, Illinois 60611-2950, United States
Site 2
Saint Louis, Missouri 63110, United States
Site 3
Bala-Cynwyd, Pennsylvania 19004, United States

References and documents

Study documents

Study protocol · Nov 20, 2020
Statistical analysis plan · Oct 9, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03880058
Lead sponsor: Scarless Laboratories, Inc.
Collaborators: ethica Clinical Research Inc.
Responsible party: Sponsor
First posted: Mar 19, 2019
Start date: Mar 3, 2019
Primary completion: May 18, 2021
Completion: May 18, 2021
Results posted: Apr 18, 2023
Last update: Apr 18, 2023

Study contacts

Robert D. Galiano, MD

principal investigator · Northwestern University

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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