Clinical trial NCT03795116: Light Emitting Diode-Red Light (LED-RL) Phototherapy for Skin Scarring Prevention
Official title: Light Emitting Diode-Red Light (LED-RL) Phototherapy for Skin Scarring Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Fibrosis
Skin Scarring
Skin Wound
Hypertrophic Scar
Scar
Keloid
Keywords: Light emitting diode
Light emitting diode-red light
Visible red light
Skin fibrosis
Wound healing
Scarring
Lead sponsor: State University of New York - Downstate Medical Center
Sponsor class: OTHER
First posted: 2019-01-07
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Skin fibrosis is a significant global health problem that has a profoundly negative impact on quality of life. Characterized by excessive fibroblast proliferation and collagen deposition, skin fibrosis underlies a wide spectrum of dermatologic conditions ranging from pathologic scars secondary to injury (e.g., burns, surgery, trauma) to immune-mediated diseases. Effective anti-scarring therapeutics remain an unmet need, underscoring the importance of developing novel approaches to treat and prevent skin fibrosis.

In vitro data show that LED-RL can modulate key cellular and molecular processes involved in skin fibrosis. Two phase I clinical trials (STARS 1 and STARS 2) demonstrated the safety and tolerability of LED-RL at fluences of 160 J/cm2 up to 480 J/cm2 on normal human skin. The administration of LED-RL phototherapy in the early postoperative period may optimize wound healing and prevent excessive scarring. The results from this study may change the current treatment paradigm for fibrotic skin diseases and help to pioneer LED-RL as a safe, non-invasive, cost-effective, portable, at-home therapy for scars.

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

Primary outcomes:
measure: Change in Scar Pliability Between the Treated and Control Incision Sites as Measured by Skin Elasticity at 6 Months Compared to Baseline
timeFrame: 1 month, 3 months, 6 months
measure: 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
timeFrame: Baseline assessment was completed on post-operative day 5, before LED-RL or mock phototherapy treatment. Follow-up visits were scheduled on approximately post-operative day 30 (1 month), post-operative 90 (3 months), and post-operative day 180 (6 months).
Secondary outcomes:
measure: Observer Scar Assessment Scale
timeFrame: Baseline assessment was completed on post-operative day 5, before LED-RL or mock phototherapy treatment. Follow-up visits were scheduled on approximately post-operative day 30 (1 month), post-operative 90 (3 months), and post-operative day 180 (6 months).
measure: Visual Analog Scale (VAS) Scoring of Digital Photographs of Scars
timeFrame: Baseline assessment was completed on post-operative day 5, before LED-RL or mock phototherapy treatment. Follow-up visits were scheduled on approximately post-operative day 30 (1 month), post-operative 90 (3 months), and post-operative day 180 (6 months).
measure: Dermal Collagen Concentration
timeFrame: Baseline assessment was completed on post-operative day 5, before LED-RL or mock phototherapy treatment. Follow-up visits were scheduled on approximately post-operative day 30 (1 month), post-operative 90 (3 months), and post-operative day 180 (6 months).
measure: Dermal Water Concentration
timeFrame: Baseline assessment was completed on post-operative day 5, before LED-RL or mock phototherapy treatment. Follow-up visits were scheduled on approximately post-operative day 30 (1 month), post-operative 90 (3 months), and post-operative day 180 (6 months).
measure: 3D Imaging Analysis: Pigmentation of Scar Tissue
timeFrame: Baseline assessment was completed on post-operative day 5, before LED-RL or mock phototherapy treatment. Follow-up visits were scheduled on approximately post-operative day 30 (1 month), post-operative 90 (3 months), and post-operative day 180 (6 months).
measure: 3D Imaging Analysis: Vascularity of Scar Tissue
timeFrame: Baseline assessment was completed on post-operative day 5, before LED-RL or mock phototherapy treatment. Follow-up visits were scheduled on approximately post-operative day 30 (1 month), post-operative 90 (3 months), and post-operative day 180 (6 months).
measure: 3D Imaging Analysis: Volume of Elevation of Scar Tissue
timeFrame: Baseline assessment was completed on post-operative day 5, before LED-RL or mock phototherapy treatment. Follow-up visits were scheduled on approximately post-operative day 30 (1 month), post-operative 90 (3 months), and post-operative day 180 (6 months).
measure: Histological Analysis: Collagen Content of Scar Tissue (Optional)
timeFrame: Skin specimens will be obtained via optional 2 mm punch biopsy on post-operative day 0 (prior to surgery) and post-operative day 30 (first follow-up visit after completion of LED-RL treatment).
measure: Number of Participants Experiencing Adverse Events in Each Treatment Group
timeFrame: From first LED-RL and mock phototherapy treatment session on post-operative day 5 until final follow-up visit on post-operative day 180 (6 month follow-up).
measure: Patient Scar Assessment Scale
timeFrame: Baseline assessment was completed on post-operative day 5, before LED-RL or mock phototherapy treatment. Follow-up visits were scheduled on approximately post-operative day 30 (1 month), post-operative 90 (3 months), and post-operative day 180 (6 months).
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: SUNY Downstate Medical Center
state: New York
Study officials:
References:
citation: Nguyen JK, Weedon J, Jakus J, Heilman E, Isseroff RR, Siegel DM, Jagdeo JR. A dose-ranging, parallel group, split-face, single-blind phase II study of light emitting diode-red light (LED-RL) for skin scarring prevention: study protocol for a randomized controlled trial. Trials. 2019 Jul 15;20(1):432. doi: 10.1186/s13063-019-3546-6.