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

NCT06936332 | Completed FDA Device

• 1 other identifier: GMT-OCL-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Acne

Keywords

acne; Light Emitting Diode Device

Outcome Measures

Primary Outcomes (3)

• Change in Inflammatory lesion counts

  Papule - A small, solid elevation less than 5 mm in diameter. Most of the lesion is above the surface of the skin. Pustule - A small circumscribed elevation less than 5 mm in diameter that contains yellow-white exudate. Nodule - An inflammatory lesion greater than or equal to 5 mm in diameter. Cyst - An inflammatory lesion that contains yellow-white exudate that is greater than or equal to 5mm in diameter.

  Baseline to Day 49 or End of Study (EOS) visit

• Change in non-inflammatory lesion counts

  Open Comedone - (Black head) A lesion in which the follicle opening is widely dilated with the contents protruding out onto the surface of the skin, with compacted melanin cells giving the plug a black appearance. Closed Comedone - (White head) A lesion in which the follicle opening is closed, but the sebaceous gland is enlarged by the pressure of the sebum buildup, which in turn cause the skin around the follicle to thin and become elevated with a white appearance.

  Baseline to Day 49 or End of Study (EOS) visit

• Percentage/Proportion of subjects who achieve at least a one-grade reduction in the IGA Score

  The Investigator will use the Investigator Global Assessment (IGA) Scale to assess the severity of a subjects' acne. The IGA Scale is a static evaluation should be performed prior to the lesion count. The IGA will be performed at Day 0, Day 21 and Day 49 or EOS. Subjects are eligible for enrollment if they have a global severity grade of a 2 (mild) or a 3 (moderate) on the IGA scale at Day 0. The following scores will be used to describe the severity grade: 0 Clear Normal, clear skin with no evidence of acne vulgaris 1. Almost Clear Rare non-inflammatory lesions present, with rare non-inflamed papules (papules must be resolving and may be hyperpigmented, though not pink red) 2. Mild Some non-inflammatory lesions are present, with few inflammatory lesions (papules/pustules only; no nodulo-cystic lesions) 3. Moderate Multiple Non-inflammatory lesions and inflammatory lesions are evident, there may or may not be one small cyst 4. Severe Inflammatory lesions are more apparent and a few cysts

  Baseline to Day 49 or End of Study (EOS) visit

Secondary Outcomes (5)

• Improvement in Investigator Acne Scarring Assessment Scores using the Quantitative Global Acne Scarring Grading System (QGAS)

  Baseline to Day 49 or End of Study (EOS) visit

• Improvement in Investigator Tolerability Assessment (erythema, edema, dryness, scaling, hypopigmentation and hyperpigmentation)

  Baseline to Day 49 or End of Study (EOS) visit

• Improvement in Acne QoL questionnaire scores

  Baseline to Day 49 or End of Study (EOS) visit

• Improvement in Acne Self Assessment questionnaire scores

  Baseline to Day 49 or End of Study (EOS) visit

• Favorable Analysis of the Omnilux Clear® Device Subject Satisfaction questionnaire

  Day 49 or EOS Visit

Other Outcomes (3)

• Improvement in the VISIA-CR photography imaging of the left, right and front views of the face.

  Baseline to Day 49 or End of Study (EOS) visit

• The frequency of both local and systemic AE's

  Baseline, Day 21 and Day 49 or End of Study visit

• Subject Tolerability Self-Assessment (itching, burning and stinging)

  Baseline, Day 21 and Day 49 or End of Study visit

Study Arms (1)

Omnilux Clear Treatment

OTHER

Omnilux Clear treatment of the facial area 4 times per week for 6 weeks. Total of 24 treatments.

Device: Omnilux Clear Light Emitting Diode Treatment

Interventions

Omnilux Clear Light Emitting Diode Treatment DEVICE

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.

Omnilux Clear Treatment

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male or females of all Fitzpatrick Skin Types who are 14 years of age or older.
• Subjects must be willing to provide verbal understanding and sign an Informed Consent Form, HIPAA Form and Photography Release Form approved by the Institutional Review Board. Subjects less than age of consent must sign an assent for the study and a parent must sign the informed consent (if subject reaches the age of consent during the study they should be re-consented at the next study visit).
• Subjects must be in general good health, as determined by the Investigator.
• Subjects willing to undergo a brief physical exam to include height, weight, blood pressure, pulse, and basic systems evaluation (Skin, Respiratory, Cardiovascular, Gastrointestinal, Endocrine, Neurological and Musculoskeletal systems) by the Investigator.
• Subjects must be willing and able to attend all study visits and comply with "At-home" Instructions.
• Subjects must be willing to have VISIA-CR facial photography imaging of their entire face for overall evaluation of their skin at all Visits.
• Subjects must be willing and able to complete and understand the various rating questionnaires.
• Subjects must have an IGA score of 2 (mild) or 3 (moderate) at the Baseline Visit.
• Subjects must have a facial acne inflammatory lesion (papules, pustules, and nodules) count with no less than 10 but no more than 50 at the Baseline Visit.
• Subjects must have a facial acne non-inflammatory lesion (open and closed comedones) count with no less than 10 but no more than 100 at the Baseline Visit.
• Subjects with 1 or fewer facial nodules at the Baseline Visit.
• Females of child bearing potential (FOCBP) and females who are premenses must be willing to practice effective contraception for the duration of the study. (Effective contraception is defined as stabilized on oral contraceptive for at least 3 months, intrauterine device, condom with spermicide, diaphragm with spermicide, implant, NuvaRing®, injection, transdermal patch or abstinence.) Females on birth control pills must have taken the same type pill for at least 3 months prior to entering the study and must not change type during the study. Those who have used birth control pills in the past must have discontinued usage at least 3 months prior to the start of the study. Women who use birth control for acne control only should be excluded.
• Premenses females and FOCBP must have a negative urine pregnancy test at the Baseline Visit.
• Subjects must be willing to comply with study instructions and return to the clinic for required visits.
• Subjects must be willing to use the cleanser, moisturizer and sunscreen provided by the Sponsor.

You may not qualify if:

• Use of an investigational drug or device within 30 days of enrollment or participation in a research study concurrent with this study.
• Any dermatological conditions on the face that could interfere with clinical evaluations such as acne conglobata, acne fulminans, secondary acne, perioral dermatitis, clinically significant rosacea, Gram-negative folliculitis, dermatitis, eczema or an allergy to silicone.
• Any underlying disease(s) or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion count inconclusive.
• Subjects with more than 50 facial acne inflammatory lesions (papules, pustules, and nodules)
• Subjects with more than 100 facial acne non-inflammatory lesions (open and closed comedones)
• Subjects with more than one (1) facial nodule.
• Subjects with a facial beard or mustache that could interfere with the study treatments and assessments.
• Subjects who have a history of experiencing significant burning or stinging when applying any facial treatment (e.g., makeup, soap, masks, washes, sunscreens, etc.) to their face.
• Female subjects who are pregnant, nursing mothers, planning a pregnancy during the course of the study, or become pregnant during the study.
• If female, subject has a history of hirsutism, polycystic ovarian disease or clinically significant menstrual irregularities.
• Subjects who have a history of lupus erythematous, photosensitive eczema, albinism, photosensitive disorders (sensitization to light of the skin or eyes), light-induced seizures or diseases that may be stimulated by visible light.
• Subjects currently using photosensitive medications or herbal supplements (see full list in Appendix IX) per the discretion of the Investigator assessment of risk.
• Subjects who have a history of Herpes Simplex in the treatment area, connective tissue damage and immunosuppressive diseases.
• Subjects who currently have active infections, broken skin, extremely dry skin or open lesions in the treatment area.
• Treatment of any type of cancer within the last 6 months in the facial area, with the exception of complete surgical excision of skin cancer outside the treatment area.

Sponsors & Collaborators

• Ablon Skin Institute Research Center: lead
• GlobalMed Technologies Co.: collaborator

Study Sites (1)

Ablon Skin Institute and Research Center

Manhattan Beach, California, 90266, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Open label study evaluating the efficacy and safety
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open label study evaluating the efficacy and safety

Study Record Dates

• First Submitted: April 13, 2025
• First Posted: April 20, 2025
• Study Start: November 18, 2024
• Primary Completion: March 10, 2025
• Study Completion: April 10, 2025
• Last Updated: April 20, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)