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

NCT06936332 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-04-20

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • GlobalMed Technologies Co.

    collaborator UNKNOWN

  • Ablon Skin Institute Research Center

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
14 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-11-18
Primary Completion
2025-03-10
Completion
2025-04-10
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06936332 on ClinicalTrials.gov