A 7-Week, Open-Label Study Evaluating the Efficacy and Safety of 415-nm/633-nm Phototherapy for Treating Mild-to-Moderate Acne in Adolescents and Adults.
Year: 2025
Type: article
Study design: Clinical Trial
Abstract: OBJECTIVE: Acne vulgaris is a major health and social concern for many adolescents and adults. The goal of this study was to further assess the efficacy and safety of a United States Food and Drug Administration cleared light-emitting diode (LED) therapy (Omnilux Clear, GlobalMed Technologies) for treating adolescents and adults with mild-to-moderate facial acne. The device is a wearable facial mask designed for home use that simultaneously emits light in red (633 nm) and blue (415 nm) wavelengths. METHODS: The study enrolled male (n=15) and female (n=15) patients aged 14 to 45 years old. Patients were required to have an Investigators Global Assessment (IGA) score of 2 (mild) or 3 (moderate). Patients applied the treatment at home 4 times weekly, never more than once daily, and allowed 24 hours between treatments. The primary efficacy endpoints were the change from baseline in inflammatory and noninflammatory lesion counts, and the proportion of patients achieving a ≥1-grade reduction in IGA scores from baseline. Other assessments included quality of life and tolerability questionnaires. RESULTS: <0.0001) and most patients (86%) achieved ≥1-grade reduction in IGA scores, meeting study success criteria. The few reported adverse events were mild and transient. LIMITATIONS: The primary limitation of this study was the open-label study design. CONCLUSION: These results provide strong support for this wearable LED device for the safe and effective home treatment of adolescents and adults with mild-to-moderate acne.
Source: PubMed
Author: Glynis Ablon
Institution: Ablon Skin Institute and Research Center
Language: English
Subfield: Dermatology
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W4417524488
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