A Study to Evaluate the Efficacy and Tolerance of 2 Acne Treatment Regimens on Subjects With Mild to Moderate Acne
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional

Summary: 
      This study will compare two different acne treatment regimens for the treatment of acne. Half
      of participants will receive a cleanser and a light therapy mask, while half of the
      participants will receive a cleanser, a light therapy topical gel-cream, and a light therapy
      mask.
    

Detailed description: 
      Acne vulgaris is a common chronic skin disease involving blockage and/or inflammation of the
      hair follicles and their accompany sebaceous glands.

      Research has shown the benefits of red and blue light therapy in the treatment of mild to
      moderate acne, with red and blue light shown to target acne-causing bacteria and have an
      effect on inflammation reduction.

      Light-based therapies have been used successfully to treat dermatological conditions since
      the early 1900s, with various parts of the electromagnetic spectrum (i.e. ultraviolet [UV],
      visible, near-infrared, etc.) demonstrating different benefits. Light-emitting diodes (LEDs)
      offer delivery of light to the skin in a gentler manner as compared to light delivered by
      lasers, primarily due to the lower energy output. It has been reported that LEDs do not
      deliver enough power to damage tissues and do not have the same risk of accidental eye damage
      that lasers do. Visible-LED light therapy has been deemed a non-significant risk by the U.S.
      Food and Drug Administration (FDA) and has been approved for use in humans.

      It is well established in the literature that visible light penetration into the epidermal
      and dermal layers of human skin is primarily governed by absorption and scattering events,
      with the latter being the more impactful of the two. Visible light penetration into human
      skin can be increased by reducing scattering. This can be accomplished by temporary hydrogen
      bonding disruption, which leads to the reversible rearrangement of epidermal and dermal
      structures that cause scattering. Glycerol (i.e. glycerin) is hypothesized to generate the
      level of hydrogen bonding disruption described above, and therefore will be investigated in
      the present study.

      This study will look to evaluate and then compare the acne clearing efficacy and tolerance of
      two different acne treatment regimens - a cleanser used with a currently marketed red and
      blue light acne light therapy mask alone vs. the cleanser used with the same mask in
      conjunction with a light therapy topical gel-cream - to determine the efficacy of these
      treatments and then to assess if the efficacy of the light therapy mask used with the topical
      gel-cream treatment is non-inferior to the mask alone in the reduction of lesions in mild to
      moderate acne. If non-inferiority is demonstrated, the mask with topical gel-cream treatment
      will be further assessed for its superiority to the mask alone.
    

Intervention name(s): Cleanser, Acne Mask; Cleanser, Gel-Cream, Acne Mask
Intervention type(s): Device; Device
Intervention description(s): A facial cleanser will be used twice daily (morning and evening). The light therapy mask will be used for 10 minutes in the evening after washing/drying the face.; A facial cleanser will be used twice daily (morning and evening). In the evening after cleansing, the gel-cream will be applied full face and allowed to dry before the light therapy mask is used for 10 minutes.
Other intervention name(s): Light Therapy Mask; Light Therapy Mask; Light Therapy Topical Gel-Cream
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acne