CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 enrolled
Drug / intervention
LED-RL phototherapy +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03795116
NCT03795116Phase 2Completed
CompareCT.gov

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

State University of New York - Downstate Medical Center·interventional·Posted Jan 7, 2019·Updated Jun 1, 2022

In Brief

A Phase 2 clinical trial evaluating LED-RL phototherapy and Mock irradiation for Fibrosis and 5 related conditions. Completed, enrolled 30 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFibrosis, Skin Scarring, Skin Wound, Hypertrophic Scar, Scar, Keloid
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedJan 7, 2019
Enrollment StartMar 18, 2019
Primary CompletionOct 26, 2020
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 7.5 years ago

Interventions

LED-RL phototherapydevice

The LED-RL treatment device has a 4.7 cm x 6.1 cm rectangular array of LEDs and emits visible red light (633 nm) at a power density of 360.2 W/m2 at room temperature and a distance of 10 mm from the target surface.

Mock irradiationdevice

The mock therapy device is designed to sound, look, and feel identical to the LED-RL treatment device (i.e., has the same physical components and thermal output), except it does not emit visible red light.