NCT06936332

Study Evaluating the Efficacy and Safety of Omnilux Clear on Mitigating Mild to Moderate Acne

A 7-week, Open Label, Single Arm Study Evaluating the Efficacy and Safety of Omnilux Clear® on Mitigating Mild to Moderate Acne in Healthy Male and Female Teenagers and Adults

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Ablon Skin Institute Research Center · Academic / Other
• Sex: All
• Age: 14 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to further substantiate the effectiveness and safety of Omnilux Clear as a stand-alone treatment of mild to moderate acne in healthy teenagers and adults 14 years of age or older over the course of 7 weeks. Participants will be screened to determine eligibility, assessed, instructed on how to use the Omnilux Clear and then treated with Omnilux Clear under the direction of the study staff during the first office visit. The first treatment will also act as a photosensitivity "patch" test to evaluate the participant for any unknown hereditary photosensitivity conditions or allergies to surface contacting materials. The particpants will then treat their face with the Omnilux Clear device at home 4 times per week for the first 6 weeks of the trial. The treatments are 10 minutes in duration. Participants will return to the study site at week 3 and week 7 for assessments, photographs and questionnaires.

Detailed description

Acne is the top skin concern for individuals in the United States. It affects subjects both physically and psychologically. While the etiology of acne is multifactorial, it does develop when the sebaceous glands in a person's skin produce excess oil. This oil combines with cells that line the gland walls and clogs the skin's pores. Normal skin bacteria (Cutibacterium acnes) colonize these pores leading to the inflammation or reddening of the skin that we associate with acne. Increasing numbers of individuals are seeking non-invasive procedures for improving medical and aesthetic dermatologic conditions. Phototherapy refers to the use of nonthermal, noninvasive light to achieve a therapeutic outcome and can apply to a variety of light-emitting devices. Interest in recent advances in the use of light emitting diodes (LED's) have led to their clinical application for a variety of medical and cosmetic uses. Depending on the target chromophore, different wavelengths of light are used. Two wavelengths of light that have demonstrated therapeutic benefit for the treatment of acne are blue (415 nm), red (633 nm) Recent publications have reignited an interest in the numerous studies performed or sponsored by a leader in the field of LED phototherapy (Omnilux™; GlobalMed Technologies, Napa, CA) which clearly demonstrate the significant value of phototherapy for a range of clinical applications. The option to offer non-invasive devices to all age individuals for the improvement of acne, is desirable. As oral medications have become less popular, home units that actually improve acne, with no pain and no downtime are indispensible. The benefits of light emitting diode (LED) therapy has become widely recognized in modern medicine. Benefits come from the specific wavelengths to target inflammation, bacteria, and healing tissue. Omnilux Clear® is a medical-grade, home LED treatment for acne-prone skin, using the most clinically effective LED's available, optimized for superior results. The blue light (415nm) targets and kills P. acnes bacteria living on the skin's surface. Red light (633nm) penetrates the dermis, triggering the body's own natural healing response, including the production of new collagen, the downregulation of excess oils, and the reduction of inflammation and redness. This FDA approved device not only reduces active acne and blemishes, redness and inflammation, but can help clear breakouts faster, reduce and soften the appearance of acne scarring all in a natural, painless way with no downtime. The purpose of this open label, single-arm clinical research study is to further substantiate the efficacy and safety of Omnilux Clear® medical grade, home LED face mask treatment as a stand-alone treatment in the mitigation of mild to moderate acne in thirty (30) healthy male and female subjects, 14 years of age or older over the course of seven (7) weeks.

Conditions

• Acne

Interventions

Type	Name	Description
DEVICE	Omnilux Clear Light Emitting Diode Treatment	Omnilux Clear is a medical-grade, home light emitting diode (LED) treatment for acne-prone skin, using the most clinically effective LED's available, optimized for superior results. The blue light (415nm) targets and kills P. acnes bacteria living on the skin's surface. Red light (633nm) penetrates the dermis, triggering the body's own natural healing response, including the production of new collagen, the downregulation of excess oils, and the reduction of inflammation and redness.

Timeline

• Start date: 2024-11-18
• Primary completion: 2025-03-10
• Completion: 2025-04-10
• First posted: 2025-04-20
• Last updated: 2025-04-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study