U0289-405: An Open-Label, 12-Week Study to Evaluate the Efficacy and Safety of the Acne System (Benzoyl Peroxide 2.5%, Salicylic Acid 0.5%) in Subjects With Acne

This open-label, multicenter, study is being conducted to obtain safety, efficacy, and
satisfaction data on an Acne System (Benzoyl Peroxide 2.5%, Salicylic Acid 0.5%), which
includes Foam Deep Cleanser (2.5% Benzoyl Peroxide) and Foam Advanced Acne Treatment (2.5%
Benzoyl Peroxide) and Foam Rejuvenating Toner (0.5% Salicylic Acid), in the treatment of
moderate to severe acne. Approximately 120 male or female subjects ages 12-35 years,
inclusive, with moderate or severe acne as assessed by Investigator's Global Assessment
(ISGA) and lesion counts are expected to be enrolled. Subjects will be instructed to use all
3 study products as part of a complete acne treatment system; no reference therapy or
control group will be included. Subjects will be instructed to apply Foam Deep Cleanser
(2.5% Benzoyl Peroxide) and Foam Advnced Acne Treatment (2.5% Benzoyl Peroxide) to the face
each morning and Foam Deep Cleanser (2.5% Benzoyl Peroxide) and Foam Rejuvenating Toner
(0.5% Salicylic Acid) each evening over an application period of 12 weeks.

Inclusion Criteria:

- Capable of understanding and willing to provide signed and dated written voluntary
informed consent (and any local or national authorization requirements) before any
protocol-specific procedures are performed.

- Male or female ages 12 to 35 years, inclusive at time of consent.

- ISGA score of 3 or 4 at Baseline.

- Lesion counts meeting all of the following criteria: A: A minimum of 25 but not more
than 50 facial inflammatory lesions (papules and pustules), excluding nasal lesions.
B: A minimum of 20 but not more than 100 facial non-inflammatory lesions (open and
closed comedones), excluding nasal lesions. C: No more than 3 facial nodular lesions
(<5mm), with no cystic lesions.

- Ability and willingness to follow all study procedures, attend all scheduled visits,
and successfully complete the study.

- Negative urine pregnancy test for females of childbearing potential.

- Sexually active females of childbearing potential participating in the study must
agree to use a medically acceptable method of contraception while receiving
protocol-assigned product.

Exclusion Criteria:

- Female who is pregnant, trying to become pregnant, or breast feeding.

- History of lupus, dermatomyositis, rosacea, seborrheic dermatitis, beard
folliculitis, polycystic ovary syndrome, hirsutism, or perioral dermatitis. (Subjects
with Seborrheic dermatitis may be enrolled if the condition has been inactive for at
least 1 year and/or it does not affect the face.)

- Use of topical antibiotics on the face within the past 2 weeks or of systemic
antibiotics for acne treatment within the past 4 weeks.

- Concurrent use of medications known to be photosensitizers (eg, thiazides,
tetracyclines, fluoroquinolones, phenothiazines, and sulfonamides) because of the
possibility of augmented photosensitivity.

- Use of topical corticosteroids on the face within the past 2 weeks or systemic
corticosteroids within the past 4 weeks. Use of inhaled, intra-articular, or
intra-lesional steroids other than for facial acne is acceptable.

- Use of systemic retinoids (eg, isotretinoin) within the past 6 months.

- Treatment with estrogens, including oral, implanted, injected, and topical
contraceptives, androgens, or anti-androgenic agents for 12 weeks or fewer
immediately prior to study enrollment. Subjects that have been treated with
estrogens, as described above, androgens, or anti-androgenic agents for more than 12
consecutive weeks prior to study enrollment are allowed to enroll as long as they do
not expect to change the dose or drug, or to discontinue use during the study and it
has not been indicated for the treatment of acne vulgaris.

- Male with facial hair that could interfere with study assessments.

- Use of topical anti-acne medications (eg, BPO, retinoids, azelaic acid, resorcinol,
sulfur and derivatives, SA, alpha or beta hydroxy acids, antioxidants, anti-wrinkle,
antimicrobials, glycolic acid, abradants) within the past 2 weeks. Use of superficial
facial procedures, and natural/herbal products within the past 4 weeks.

- Concomitant use of medications that are reported to exacerbate acne as these may
impact efficacy assessments.

- Facial procedure (eg, blue light, chemical or laser peel, microdermabrasion)
performed by aesthetician, beautician, physician, nurse, or other practitioner within
the past 8 weeks.

- facial skin cancer diagnosis in preceding 12 months.

- Require or desire excessive or prolonged exposure to ultraviolet light (eg, sunlight
or tanning beds) during the study.

- Dermatological disorder that in the opinion of the investigator may interfere with
the accurate evaluation of the subject's facial appearance.

- Any major illness within 4 weeks before study enrollment.

- Previous use of the study products.

- Use of any investigational drug or procedure within the past 4 weeks or currently
participating in another clinical study.

- Known hypersensitivity or previous allergic reaction to any of the active components
of the study product.

- Any other condition which, in the judgement of the investigator, would put the
subject at unacceptable risk for participation in the study.

- Current drug or alcohol abuse. (Drug screening is not required.)

- Considered unable or unlikely to attend the necessary visits.

- Employee of the investigator, clinical research organization, Stiefel, a GSK company,
or GlaxoSmithKline (GSK) who is involved in the study, or an immediate family member
(eg, partner, offspring, parents, siblings or sibling's offspring) of an employee who
is involved in the study.