Aczone Gel 7.5% in the Treatment of Acne Vulgaris in Patients With Skin of Color

Acne vulgaris is a common skin disease characterized by inflammatory papules, pustules, and
comedones that is prevalent in men and women of color. In fact, acne is the most common
dermatologic diagnosis made in SOC populations. Although individuals of all skin types can
develop acne vulgaris, there are important differences in darker skin types that are
important to consider when choosing an optimal treatment.

Complications from acne are of great concern in this population, as keloids, hypertrophic
scars, and post-inflammatory hyperpigmentation (PIH) are more common in skin of color. PIH
may last for weeks to months and, in many cases, is more troublesome to patients than the
acne itself. Overall, facial acne and its sequelae have a greater impact on perception of
appearance, negative emotions, and social functioning in women of color than white women.

Dapsone is a sulfone compound with anti-inflammatory properties that has been shown to be
effective in the treatment of acne vulgaris in SOC. Aczone ® (dapsone) gel, 5% administered
twice daily has been associated with significant improvement in overall acne severity, acne
signs, and impact on quality of life in women of color. Two phase III trials of a newer
formulation of Aczone ® (dapsone) gel, 7.5% used once daily demonstrated that this product is
effective, safe, and well-tolerated for the treatment of acne in both men and women; however,
limited data is available regarding its efficacy and safety in SOC.

Further, some investigators of the phase IV study on the safety and efficacy of dapsone gel
5% in SOC anecdotally reported improvement in hyperpigmentation over 12 weeks, although this
was not a planned efficacy outcome. Further research is needed on the potential effects of
dapsone gel on hyperpigmentation and PIH in SOC.

The current study will investigate the therapeutic impact of Aczone gel 7.5% in SOC males and
females ages 18 and older with acne vulgaris. The study will also evaluate the impact of
Aczone gel on post-inflammatory hyperpigmentation using the Postacne Hyperpigmentation Index
(PAHPI) and mexameter-measured melanin index (MI).

Inclusion Criteria:

- Provide written, signed and dated informed consent prior to initiating any
study-related activities.

- Male or female subjects who are ≥ 18 years of age

- Subjects with Fitzpatrick Skin Type IV, V, or VI

- Subjects with moderate to severe acne as defined by investigator- assessed Global Acne
Assessment Score (GAAS) of 3 or 4 at screening

- Facial acne vulgaris with 20 to 50 (inclusive) inflammatory lesions and 30 to 100
(inclusive)non inflammatory lesion

- Stable non-progressive or regressive acne vulgaris in the investigator's opinion

- Females of childbearing potential (FCBP) must have a negative pregnancy test at
Screening and Baseline. A female is considered not to be of childbearing potential if
she is post-menopausal with at least 12 consecutive months of amenorrhea or has
undergone surgical sterilization. While on investigational product and for at least 28
days after taking the last dose of investigational product, FCBP who engage in
activity in which conception is possible must use one of the approved contraceptive
options described below:

Option 1: Any one of the following highly effective methods: hormonal contraception (oral,
injection, implant, transdermal patch, vaginal ring); intrauterine device (IUD); tubal
ligation; or partner's vasectomy; OR Option 2: Male or female condom (latex condom or
nonlatex condom NOT made out of natural [animal] membrane [for example, polyurethane]; PLUS
one additional barrier method: (a) diaphragm with spermicide; (b) cervical cap with
spermicide; or (c) contraceptive sponge with spermicide.

- Must be in general good as judged by the Investigator

- Subject is willing to avoid excessive or prolonged exposure of the treated skin to
ultraviolet light (i.e. sunlight, tanning beds) throughout the study

- Subject is willing to follow study instructions and complete study assessments without
assistance and is likely to complete all required visits

Exclusion Criteria:

- Diagnosis of other dermatologic diagnosis that, in the opinion of the investigator,
would interfere with diagnosis, examination, or treatment of the studied condition
(i.e. psoriasis, atopic dermatitis, lupus, dermatomyositis, seborrheic dermatitis,
perioral dermatitis, etc.)

- Subjects with severe cystic acne, acne conglobate, acne fulminans, or secondary acne
(chloracne or drug-induced acne)

- Uncontrolled systemic disease(s) that, in the opinion of the investigator, would put
the patient at significant risk if enrolled in the study or would interfere with
subject's participation in the study

- Subjects with a history of clinically significant hemolysis, anemia, or enteritis
(regional enteritis, ulcerative colitis, pseudomembranous colitis,
antibiotic-associated colitis)

- Subjects with allergy or sensitivity to the study drug or its components

- Subjects who have not complied with the proper wash-out periods:

- Topical anti-inflammatory medications, salicylic acid, corticosteroids,
antibiotics, antibacterials, peroxide-containing products, or retinoids within 2
weeks of baseline

- Systemic antibiotics, corticosteroids, antimalarials or oral dapsone within 4
weeks of baseline Other anti-acne medication, including isotretinoin or
spironolactone, within 6 months of baseline

- Chemical peels or other facial acne procedures (laser therapy, light therapy)
within 3 months of baseline

- Treatment with botulinum toxin of any serotype in the face within 6 months of
baseline

- Estrogens/Birth control pills must have been started ≥ 90 days prior to baseline
and use must be continued during the study without alteration or discontinuation.

- Pregnant or breast feeding.

- Subjects with evidence of alcohol or substance abuse.

- Use of any investigational drug within 4 weeks prior to randomization, or 5
pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer).