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

Completed · Not applicable

Conditions studied: Acne

In brief

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.

Key facts

Study ID

NCT06936332

Run by

Ablon Skin Institute Research Center

People needed

30

Starts

2024-11-18

Expected to finish

2025-04-10

Last updated by the study team

2025-04-20

Who can join

Age: 14 and older. Sex: any. Healthy volunteers: accepted.

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.
• If the subject wears makeup, they must agree to use non-comedogenic makeup.
• Male subjects facial area must be clean-shaven for all study visits as to not interfere with study treatments and assessments.

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.
• Subjects who have not undergone the specified washout period(s) for the following topical preparations/physical treatments used on the face or subjects who require the concurrent use of any of the following in the treatment area:
• Topical astringents and abrasives on the face 1 week Non-allowed moisturizers or sunscreens on the face 1 week Acne surgery 1 week Soaps containing antimicrobials on the face 1 week Antibiotics on the face 2 weeks Other topical anti-acne drugs on the face 2 weeks Chemical peel/Microdermabrasion on the face 2 weeks Light (PDT) therapy on the face 2 weeks Anti-inflammatory agents and corticosteroids on the face 4 weeks Retinoids, including retinol on the face 4 weeks Laser therapy on the face 4 weeks
• Subjects who have not undergone the specified washout period(s) for the following systemic medications or subjects who require the concurrent use of any of the following systemic medications:
• Corticosteroids (including intramuscular injections) (inhaled corticosteroids are allowed) 4 weeks Antibiotics 4 weeks Other systemic acne treatments 4 weeks Systemic retinoids 6 months
• Subject intends to use a tanning booth or sunbathe during the study. 21. Subjects who are unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function.
• Subjects with any underlying disease that the investigator deems uncontrolled, and poses a concern for the subject's safety while participating in the study.

Where it is running

• Ablon Skin Institute and Research Center — Manhattan Beach, California, United States

Full record on ClinicalTrials.gov

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