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

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.

Inclusion criteria

• 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.

Exclusion criteria

• 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.