A Study to Evaluate the Effectiveness and Tolerance of Two Acne Treatments 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 treatments for the treatment of acne. Half of the
      participants will receive two marketed acne products (cleanser and leave-on topical
      treatment), while the other half of the participants will receive a marketed cleanser and a
      light-therapy device.
    

Detailed description: 
      Acne is a common chronic skin disease involving blockage and/or inflammation of the hair
      follicles and their accompanying sebaceous gland.

      Benzoyl peroxide (BPO) is one of the most effective and well-studied over-the-counter (OTC)
      acne therapies, is generally regarded as safe and effective and is considered as a first-line
      treatment for acne. Topical BPO monotherapy products for at-home acne treatment have been
      available for OTC use for more than 30 years and studies have indicated that a low dose of
      BPO may be an effective approach for treating acne using an OTC product when applied
      consistently to larger areas of the face due primarily to its effects against acne-causing
      bacteria.

      BPO has anti-inflammatory and keratolytic properties, but is thought to act primarily to
      control P. acnes by releasing reactive oxygen species that are toxic to the bacteria. The
      most common side effect of topical BPO treatment is skin irritation, which can include
      erythema, burning, and peeling.

      As an alternative to topical OTC standard of care therapies, research has also 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 the acne-causing bacteria and have an effect on inflammation
      reduction.

      Light-based therapies have been successfully used to treat dermatological conditions since
      the early 1900's, with various parts of the electromagnetic spectrum (i.e. 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 Food and
      Drug Administration and has been approved for use in humans.

      This study will look to compare the acne clearing efficacy and tolerance of two different
      acne treatments: a currently marketed 2.5% BPO full-face topical OTC treatment, and an
      Investigational red and blue light acne light therapy mask, to determine if the acne
      resolution efficacy of the Investigational mask is as effective as a current OTC standard of
      care for at-home treatment of mild to moderate acne.
    

Intervention name(s): Acne Mask; 2.5% Benzoyl Peroxide Treatment
Intervention type(s): Device; Drug
Intervention description(s): The light therapy device contains a combination of red and blue light-emitting diodes. The device is applied once daily, in the evening for a duration of 10 minutes; The BPO treatment is applied twice daily, once in the morning and once in the evening
Other intervention name(s): Light-Therapy Acne Device; BPO
Intervention MeSH terms: Benzoyl Peroxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Acne