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NCT03880058

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

Completed Phase 1, PHASE2 Results posted Last updated 18 April 2023
What this trial tests

Phase 1, PHASE2 trial testing SLI-F06 in Scars in 22 participants. Completed in 18 May 2021.

Timeline
3 March 2019
Primary endpoint
18 May 2021
18 May 2021

Quick facts

Lead sponsorScarless Laboratories, Inc.
PhasePhase 1, PHASE2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment22
Start date3 March 2019
Primary completion18 May 2021
Estimated completion18 May 2021
Sites3 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Scarless Laboratories, Inc. — full company profile →

Who can join

18 and older, any sex, with Scars. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Patient and Observer Scar Assessment Scale (POSAS) - PI Assessment Primary · Post-excision at Month 3

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.

GroupValue95% CI
SLI-F064.4± 1.7
Formulation Buffer4.5± 1.7
Patient and Observer Scar Assessment Scale (POSAS) - PI Assessment Primary · Post-abdominoplasty at Month 12

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.

GroupValue95% CI
SLI-F061.6± 1.7
Formulation Buffer1.7± 1.7

Adverse events — posted to ClinicalTrials.gov

Time frame: 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).. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

SLI-F06
Serious: 3/22 (14%)
Deaths: 0/22
Formulation Buffer
Serious: 3/22 (14%)
Deaths: 0/22

Serious adverse events (3 terms)

ReactionSystemSLI-F06Formulation Buffer
Pulmonary embolismVascular disorders
Abortion spontaneousPregnancy, puerperium and perinatal conditions
NephrolithiasisRenal and urinary disorders
Other adverse events (37 terms — click to expand)

ReactionSystemSLI-F06Formulation Buffer
CellulitisInfections and infestations
NasopharyngitisInfections and infestations
Seroma drainageSurgical and medical procedures
Umbilical herniaGastrointestinal disorders
AlopeciaSkin and subcutaneous tissue disorders
Skin necrosisSkin and subcutaneous tissue disorders
SeromaInjury, poisoning and procedural complications
PyrexiaGeneral disorders
HeadacheNervous system disorders
Aortic arteriosclerosisVascular disorders
Abdominal herniaGastrointestinal disorders
PneumoniaRespiratory, thoracic and mediastinal disorders
Dermoid cystNeoplasms benign, malignant and unspecified (incl cysts and polyps)
AscitesGastrointestinal disorders
AtelectasisRespiratory, thoracic and mediastinal disorders
Synovial cystNeoplasms benign, malignant and unspecified (incl cysts and polyps)
Sinus tachycardiaCardiac disorders
Chest painGeneral disorders
Allergy to surgical suturesGeneral disorders
Tension headacheNervous system disorders
Urinary tract infectionInfections and infestations
HypersensitivityImmune system disorders
ContusionInjury, poisoning and procedural complications
Drain site complicationInjury, poisoning and procedural complications
TendonitisMusculoskeletal and connective tissue disorders
Influenza like illnessGeneral disorders
Incision site hemorrhageInjury, poisoning and procedural complications
Dermatitis allergicImmune system disorders
InfluenzaInfections and infestations
FlatulenceGastrointestinal disorders
ConstipationGastrointestinal disorders
Impaired healingGeneral disorders
NauseaGastrointestinal disorders
VomitingGastrointestinal disorders
Skin irritationSkin and subcutaneous tissue disorders
Dermatitis contactSkin and subcutaneous tissue disorders
Wound dehiscenceInjury, poisoning and procedural complications

Most-reported serious reactions: Pulmonary embolism, Abortion spontaneous, Nephrolithiasis.

Data from ClinicalTrials.gov NCT03880058 adverse events section.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Breakthrough treatments for accelerated wound healing.
    Freedman BR, Hwang C, Talbot S, Hibler B, et al · · 2023 · cited 227× · PMID 37196080 · DOI 10.1126/sciadv.ade7007
  2. Small Leucine-Rich Proteoglycans in Skin Wound Healing.
    Pang X, Dong N, Zheng Z. · · 2019 · cited 44× · PMID 32063855 · DOI 10.3389/fphar.2019.01649
  3. Fibromodulin, a Multifunctional Matricellular Modulator.
    Zheng Z, Granado HS, Li C. · · 2023 · cited 37× · PMID 36515321 · DOI 10.1177/00220345221138525
  4. Fibroblasts in Diabetic Foot Ulcers.
    Voza FA, Huerta CT, Le N, Shao H, et al · · 2024 · cited 36× · PMID 38396848 · DOI 10.3390/ijms25042172
  5. The role of fibromodulin in inflammatory responses and diseases associated with inflammation.
    Zhao F, Bai Y, Xiang X, Pang X. · · 2023 · cited 15× · PMID 37483637 · DOI 10.3389/fimmu.2023.1191787
  6. Preclinical Efficacy and Safety Study of a Novel Dermal Fibroblast Modulating Drug, SLI-F06, in Cutaneous Wound Healing.
    Zheng Z, Ha P, Li C, Chang GX, et al · · 2026 · PMID 42253930 · DOI 10.1002/mco2.70761

Verify or expand the search:

Other trials of SLI-F06

Trials testing the same drug.

Other recruiting trials for Scars

Currently open trials in the same condition.

Other Scarless Laboratories, Inc. trials

Trials by the same sponsor.

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