Evaluation of the Efficacy and Tolerance of a Light Therapy Mask on Mild to Moderate Brown Spots and Moderate to Severe Facial Wrinkles
Condition: Skin Aging
Study type: Interventional

Summary: 
      This research study will test how well a light therapy mask works for women with mild to
      moderate hyperpigmentation (brown spots) and moderate to severe facial wrinkles, as compared
      to a "sham" or inactive investigational light therapy mask. The study will also test if the
      light therapy mask causes any irritation. For the first 12 weeks of the study, participants
      will use the assigned mask, along with a provided cleanser and sunscreen. For the second 12
      weeks of the study, participants will use just the cleanser and sunscreen.
    

Detailed description: 
      Exposure to sunlight and artificial light sources containing ultraviolet (UV) radiation is
      known to accelerate the skin's aging process, resulting in unwanted wrinkles, irregular skin
      tone, and loss of elasticity. Ablative techniques, such as dermabrasion, deep chemical peels,
      and ablative laser resurfacing of various wavelengths, are well documented to alleviate the
      signs of photodamage. However, such techniques often require significant post-treatment care
      and have higher risk profiles than other treatments, with potential side effects including
      erythema, pigmentation issues, infection, and possible scarring. They may be poorly tolerated
      by patients who dislike the discomfort, wound care, and prolonged downtime involved.

      Non-ablative skin rejuvenation procedures are also effective for improving the appearance of
      photodamaged skin and are becoming increasingly popular because of their minimal downtime and
      increased safety. These procedures include intense pulsed light systems, non-ablative lasers,
      and monochromatic light boxes, which can target facial rhytids, irregular pigmentation,
      telangiectasia, and skin laxity. Unfortunately, such techniques can be expensive and their
      use is primarily limited to clinical settings.

      However, the light-emitting diode (LED) is a novel light source that is well-suited for
      non-ablative phototherapy that can be utilized at home for a relatively low price. This study
      will evaluate the efficacy and tolerance of an LED-based light therapy mask as compared to a
      sham mask in subjects seeking anti-aging benefits.
    

Intervention name(s): Active Mask; Sham Mask
Intervention type(s): Device; Device
Intervention description(s): A facial cleanser will be used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF will be applied full-face. For the first 12 weeks of the study, the active light therapy mask will be used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage will be discontinued.; A facial cleanser will be used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF will be applied full-face. For the first 12 weeks of the study, the sham light therapy mask will be used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage will be discontinued.
Other intervention name(s): Active Light Therapy Mask; Sham Light Therapy Mask
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Photoaging of Skin, Skin Wrinkling, Solar Aging of Skin, light therapy