A Study to Evaluate the Efficacy and Tolerance of 2 Acne Treatment Regimens on Subjects With Mild to Moderate Acne

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.

Inclusion Criteria:

- Has mild to moderate facial acne

- Has 10-100 blackheads/whiteheads, 10-50 pimples, no cysts, and up to 2 large, hard,
painful bumps (nodules)

- Able to read, write, speak, and understand English

- In general good health

- Must agree to practice a medically acceptable form of birth control.

- Intends to complete the study and willing to follow all study instructions.

Exclusion Criteria:

- Very sensitive skin or allergies/sensitivity to skincare products or the test product
ingredients.

- Has a light or photosensitivity disorder or another medical condition that could
increase risk to the subject or confuse the study results

- Is using medication that makes skin more sensitive to light

- Has severe acne or a pre-existing facial skin condition other than mild to moderate
acne

- has an immune deficiency disorder

- has been using a product or medication that the stuff investigator determines will
increase health risk to the subject or confuse the study results

- Females that are pregnant, nursing, or planning to become pregnant

- Males with a female partner who is pregnant or planning to become pregnant

- Has excessive facial hair

- Is participating in another study within past 4 weeks

- Is related to the Sponsor, Investigator, or Study Site