Efficacy of an LED Mask

At-home LED (light-emitting diode) devices are one of the category's fastest-growing segments. Their appeal rests partly on clinical evidence that red and near-infrared light can contribute to factors associated with skin health. The central aim of this study is to investigate the effects of daily use of an at-home device that delivers a 9 minute treatment of red and near-infrared light therapy on skin health after 12 weeks. Participants will complete one baseline visit in order to assess the acute effects of this therapy. Outcomes measures, including expert assessment and participant subjective health of skin of the face, will be taken at 6 and 12 weeks of daily treatment.

• Light emitting diode treatment (Device): Participants will use the device for a 9-minute treatment (4.5 min red light and 4.5 minutes red + infrared light therapy) 7 days a week for 12 weeks

Primary outcomes

• Expert Clinical Grading [From enrollment to the end of treatment at 12 weeks]: Assessments will be performed by a trained clinical grader and skin attributes will be assessed using an Ordinal Scale of 0 to 9 (modified Griffiths scale) on all subjects' faces. Outcome measures include: Firmness, fine lines, wrinkles, skin sagginess, radiance/luminosity, skin texture/smoothness, dark spot, skin tone evenness, contour of the jawline, overal skin appearance
• Subjective and objective tolerance to device use [From enrollment to the end of treatment at 12 weeks]: Tolerance will be graded objectively through ratings performed by a clinical grader relating to erythema, dryness, and edema, rated on a 4-point scale (0 = none, 3 = severe intensity). Subjective tolerance will be graded by the participant relating to stinging, tingling, itching, and burning on a 4 point scale (0 = none; 3 = severe).
• Cutometer [From enrollment to the end of treatment at 12 weeks]: The cutometer measures the viscoelastic properties of the skin by measuring the skin's response to the application of a probe. The Cutometer MPA 580 (Courage and Khazaka, Germany) device will be set to 450 mbar of pressure with a 6 second run time (3 seconds on and 3 seconds off). The curves will result in curves of R0 (mm), R5 (arbitrary units) and R7 (arbitrary units).
• VISIA-CR [From enrollment to the end of treatment at 12 weeks]: The VISIA-CR is a clinical facial imaging system used to analyze skin conditions. Images are taken in a variety of positions (frontal, left and right profiles) in consistent lighting. Image analysis for fine lines/wrinkles, skin texture/roughness, dark spots/hyperpigmentation, pores and redness will be performed with the VISIA-CR software.
• Digital Photography [From enrollment to the end of treatment at 12 weeks]: Clinical photography involves analysis of high-resolution images taken at different angles (right profile, 45 degrees right, straight on, 45 degrees left and 90 degrees left) to compare in a side-by-side format at each time point.
• Self-assessment questionnaire [From enrollment to the end of treatment at 12 weeks]: Participants will complete their perceived experience and comfort of use. Skin benefits including: firmness, appearance of fine lines, wrinkles (depth and appearance), radiance, plumpness, evenness, texture, redness, pigmentation, oiliness, pore appearance, dark spots, tightness, sagginess, texture, blemishes, appearance, health, scars/imperfections. All questions are on a 6 point scale (strongly agree to strongly disagree)

Sex: All, ages: 25 Years to 65 Years

Inclusion Criteria:

* Age: 35-65 years (inclusively)
* In good general health
* Sex: Female and Male (approximately 10% male)
* Ethnicity: Open to all with representation of at least one completer across the following key ethnic groups: Hispanic, African American, and Asian.
* Fitzpatrick Skin Type: Open to all with representation of at least one completer within each Fitzpatrick skin type category (I-VI).
* Individuals presenting with self-perceived sensitive skin (approximately 50% of the population).
* Individuals presenting with self-perceived redness (Fitz I-IV), visible and clogged pores, uneven skin tone and at least one (1) dark spot present on the face.
* Individuals with mild to moderate severity \[scores 3-6 on the 10-point modified Griffiths scale\] for the following attributes on their face as determined by a clinical expert grader:

  * Firmness (Tactile)
  * Firmness (Visual)
  * Fine Lines (Visual)
  * Wrinkles (Visual)
  * Skin Radiance/Luminosity (Visual)
  * Skin Sagginess (Visual)
  * Skin Texture/Smoothness
  * Dark Spot
  * Skin Tone Evenness
  * Contour of the Jawline
  * Overall Skin Appearance
* Male subjects must have a clean-shaven face prior to each study visit. No facial hair will be permitted, and individuals must maintain same shave habits for the duration of the study. Also, males must avoid shaving on the day of each visit.
* Agree to wear the provided tanktop for each visit to allow replicate photographs to be taken during all time points of the study (Cell 1 only - if selected by the Sponsor).
* Capable and willing to read and understand English and agree to sign an informed consent and photographic release form.
* Free of any skin condition(s) and have no history of skin condition(s) at the test site(s) that could interfere with the purpose, conduct, or integrity of the study.
* Agree to avoid any professional face procedures (chemical peels, facial laser treatments, facials, Botox/fillers, etc.) during the course of the study.
* Agree to arrive at the testing facility for each visit with clean skin and without any products (i.e., lotions, creams, makeup, etc.) applied to the test area (face).
* Agree not to introduce new personal care products during the course of the study.
* Agree not to use any chemical exfoliants (AHA/BHA) products during the course of the study.
* Agree to not introduce any new face masks (LED or topical), except the test product provided, during course of the study.
* Agree to avoid excessive sun exposure and the use of artificial tanning methods for the duration of the study.

Exclusion Criteria:

* Individuals with any visible dermatological skin condition(s) that could interfere with the conduct of the study or increase the risks to the test subject (i.e., excessive redness or dryness, abnormal pigmentation, unusual mole).
* Individuals with any self-reported skin disorders, including a known history of allergies or other medical conditions (i.e., atopic eczema, psoriasis, or onychomycosis) which, in the opinion of the Clinical Investigator, could interfere with the conduct of the study, interpretation of results, or increase the risk of adverse reactions.
* Individuals with facial tattoos, eyelash extensions, rashes, scratches, scars, or burn marks on the test site (face) that may interfere with the study assessments. Natural-looking eyebrow tattoos and eyelash extensions are permitted as long as they keep it consistent throughout the study.
* Individuals who make chronic use of alcohol, tobacco, or recreational drugs.
* Individuals with chapped skin or open wounds (i.e., lacerations or abrasions) (self-reported or detected by testing facility staff).
* Individuals who have been diagnosed by a physician as having any neurological condition that reduces your touch or pain sensitivity, such as peripheral neuropathy.
* Individuals who have photosensitivity (i.e., sun allergy) or are using photosensitive drugs such as Doxycycline, Tetracycline, Ciprofloxacin, Isotretinoin, Benzoyl Peroxide, etc.
* Individuals who have had chemical peels, facial laser treatments, facials, Botox/fillers, light therapy in the last month and not allowed during study.
* Individuals who have a known (self-reported) allergy to any cosmetic and/or personal care products, and LED devices.
* Women who are pregnant (self-reported), planning a pregnancy, or nursing a child during the study.
* Individuals taking medications or who have used topical or systemic medication within 14 days of study entry that could interfere with the test results, including any regimen of anti-inflammatory drugs, antihistamines, immunosuppressants, or retinoids
* Individuals currently under the treatment for asthma or diabetes (insulin-dependent only).
* Concurrent participation in any other study involving the face or neck, or in any studies testing oral supplements.
* Individuals who have participated in other studies for LED face devices in the past 3 months.
* Individuals who have Hashimoto's Disease, Rheumatoid Arthritis, or any other autoimmune disorder.
* Employees of ALS or their dependents and/or relatives.