Phase 2 N=60 Randomized Double-blind Treatment

Light Emitting Diode-Red Light (LED-RL) Phototherapy for Skin Scarring Prevention

Fibrosis · Skin Scarring · Skin Wound · Hypertrophic Scar · Scar

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View on ClinicalTrials.gov: NCT03795116 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2022

Primary outcome: Primary: Change in Scar Pliability Between the Treated and Control Incision Sites as Measured by Skin Elasticity at 6 Months Compared to Baseline

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: LED-RL phototherapy (Device); Mock irradiation (Device)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: State University of New York - Downstate Medical Center
Primary completion: Oct 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Scar Pliability Between the Treated and Control Incision Sites as Measured by Skin Elasticity at 6 Months Compared to Baseline	—	—
PRIMARY Change in Scar Pliability Between the Treated and Control Incision Sites as Measured by Skin Induration at Three Follow-up Time Points Compared to Baseline	.08; .05; .09; .06; .06; .07	—
SECONDARY Observer Scar Assessment Scale	16.5; 16.5; 19.0; 14.0; 18.0; 16.5	—
SECONDARY Visual Analog Scale (VAS) Scoring of Digital Photographs of Scars	—	—
SECONDARY Dermal Collagen Concentration	48.7; 52.0; 51.0; 50.5; 47.7; 52.5	—
SECONDARY Dermal Water Concentration	63.0; 65.3; 60.7; 62.7; 63.2; 66.2	—
SECONDARY 3D Imaging Analysis: Pigmentation of Scar Tissue	—	—
SECONDARY 3D Imaging Analysis: Vascularity of Scar Tissue	—	—
SECONDARY 3D Imaging Analysis: Volume of Elevation of Scar Tissue	—	—
SECONDARY Histological Analysis: Collagen Content of Scar Tissue (Optional)	—	—
SECONDARY Number of Participants Experiencing Adverse Events in Each Treatment Group	0; 0; 1; 0; 1; 0	—
SECONDARY Patient Scar Assessment Scale	36.0; 37.0; 32.0; 30.5; 26.5; 28.5	—

Summary

Skin scarring (fibrosis) is a common complication in the wound healing process and remains a therapeutic challenge. Scar formation often occurs following injury to the skin such as surgery, trauma, and burns. The goal of this study is to evaluate the safety and efficacy of visible red light as a modality to reduce skin scarring after mini-facelift surgery. Based on laboratory data, light emitting diode-red light (LED-RL) phototherapy may lessen post-surgical skin fibrosis clinically.

Eligibility Criteria

Inclusion Criteria

Provision of written informed consent for all study procedures
Stated willingness to comply with all study procedures and availability for the duration of the study
Suitable candidate for elective mini-facelift surgery
Pass a screening photosensitivity test

Exclusion Criteria

Current use of any photosensitizing medications
Light-sensitive conditions
Diabetes mellitus
Systemic lupus erythematosus
Current tobacco use
History of bleeding or coagulation disorder
Lax skin associated with genetic disorders
Open wounds on the face or neck
Fibrotic skin disease, pre-existing scar(s), or other skin conditions affecting the periauricular skin
History of surgery or procedure involving or affecting the periauricular skin within the past 6 months (e.g., prior facelift, fillers, laser therapy)
Tattoos that cover the proposed treatment sites on the periauricular skin
Any other medical condition(s) that could be compromised by exposure to the proposed treatment

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03795116). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.