Study Comparing Test to Aczone 7.5% and Both to a Placebo Control in the Treatment of Acne Vulgaris
Study Comparing Test to Aczone 7.5% and Both to a Placebo Control in the Treatment of Acne Vulgaris
To evaluate the therapeutic effect of Dapsone and Placebo gel in the treatment of acne
 vulgaris.
A Multicenter, Double Blind, Randomized, Placebo Controlled, Parallel Group study comparing
 Dapsone to ACZONE Gel and active treatment to a Placebo control in the treatment of Acne
 Vulgaris
Inclusion Criteria:

 1. Healthy male or non-pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis
 of acne vulgaris.

 2. Subjects who are 18 years of age or older (up to the age of 40 inclusive) must have
 provided IRB approved written informed consent. Subjects ages 12 to 17 years of age
 inclusive must have provided IRB approved written assent; this written assent must be
 accompanied by an IRB approved written informed consent from the Subject's legally
 acceptable representative (i.e., parent or guardian). In addition, all Subjects or
 their legally acceptable representatives (i.e., parent or guardian) must sign a HIPAA
 authorization.

 3. Subjects must have a minimum ≥ 25 non-inflammatory lesions (i.e., open and closed
 comedones) AND ≥ 20 inflammatory lesions (i.e., papules and pustules) AND ≤ 2
 nodulocystic lesions (i.e., nodules and cysts), at baseline on the face. For the
 purposes of study treatment and evaluation, these lesions should be limited to the
 facial treatment area. All lesions will be counted, including those present on the
 nose. Subjects may have acne lesions on other areas of the body which will also be
 excluded from the count, treatment, and the Investigator's Global Assessment (IGA)
 evaluation (e.g., on the back, chest and arms).

 4. Subjects must have a definite clinical diagnosis of acne vulgaris of severity grade 2,
 3, or 4 as per the Investigator's Global Assessment (IGA).

 5. Subjects must be willing to refrain from using all other topical acne medications or
 antibiotics during the 12-week treatment period for acne vulgaris, other than the
 Investigational Product.

 6. Female Subjects of childbearing potential (excluding women who are premenarchal,
 surgically sterilized or postmenopausal for at least 1 year), in addition to having a
 negative urine pregnancy test, must be willing to use an acceptable form of birth
 control during the study from the day of the first dose administration to 30 days
 after the last administration of study drug . For the purpose of this study the
 following are considered acceptable methods of birth control: oral or injectable
 contraceptives, contraceptive patches, Depo-Provera® (stabilized for at least 3
 months) NuvaRing® (vaginal contraceptive);Implanon™ (contraceptive implant), double
 barrier methods (e.g. condom and spermicide),Intrauterine Device (IUD), Essure, or
 abstinence. If a subject who was abstinent becomes sexually active during the study, a
 2nd acceptable method of birth control should be documented. A sterile sexual partner
 is NOT considered an adequate form of birth control. Hormonal contraceptives should
 not be initiated or changed during the study.

 7. All male Subjects must agree to use accepted methods of birth control with their
 partners, from the day of the first dose administration to 30 days after the last
 administration of study drug. Abstinence is an acceptable method of birth control.
 Female partners should use an acceptable method of birth control as described in the
 above Item Number 6.

 8. Subjects must be willing and able to understand and comply with the requirements of
 the protocol, including attendance at the required study visits.

 9. Subjects must be in good health and free from any clinically significant disease,
 including but not limited to, conditions that may interfere with the evaluation of
 acne vulgaris. Such conditions include, but are not limited to the following:
 autoimmune disease, rosacea; seborrheic dermatitis; perioral dermatitis;
 corticosteroid-induced acne; carcinoid syndrome; mastocytosis; acneiform eruptions
 caused by make-up, medication, facial psoriasis and facial eczema.

 10. Subjects who use make-up must have used the same brands/types of make-up for a minimum
 period of 14 days prior to study entry and must agree to not change make-up brand/type
 or frequency of use throughout the study.

 Exclusion Criteria:

 1. Female Subjects who are pregnant, nursing or planning to become pregnant during study
 participation.

 2. Subjects with a history of hypersensitivity or allergy to dapsone and/or any of the
 study medication ingredients and its excipients.

 3. Subjects with the presence of any skin condition that would interfere with the
 diagnosis or assessment of acne vulgaris (e.g., on the face: rosacea, dermatitis,
 psoriasis, squamous cell carcinoma, eczema, acneiform eruptions caused by medications,
 steroid acne, steroid folliculitis, or bacterial folliculitis).

 4. Subjects with excessive facial hair (e.g. beards, sideburns, moustaches, etc.) that
 would interfere with diagnosis or assessment of acne vulgaris.

 5. Subjects who have performed wax depilation of the face within 14 days prior to
 baseline.

 6. Subjects who have used within 6 months prior to baseline or use during the study of
 oral retinoids (e.g. Accutane®), or therapeutic vitamin A supplements of greater than
 10,000 units/day (multivitamins are allowed).

 7. Subjects who have used estrogens or oral contraceptives for less than 3 months prior
 to baseline; use of such therapy must remain constant throughout the study.

 8. Subjects who have used any of the following procedures on the face within 1 month
 prior to baseline or use during the study:

 1. cryodestruction or chemodestruction,

 2. dermabrasion,

 3. photodynamic therapy,

 4. acne surgery,

 5. intralesional steroids, or

 6. X-ray therapy.

 9. Subjects who have used any of the following treatments within 1 month prior to
 baseline or during the study:

 1. systemic steroids,

 2. spironolactone,

 3. systemic antibiotics,

 4. systemic treatment for acne vulgaris (other than oral retinoids, which require a
 6-month washout), or

 5. systemic anti-inflammatory agents

 10. Subjects who have used any of the following treatments within 2 weeks prior to
 baseline or during the study:

 1. topical steroids,

 2. topical retinoids,

 3. topical acne treatments including over-the-counter preparations,

 4. topical anti-inflammatory agents, or

 5. topical antibiotics.

 11. Subjects who have received radiation therapy and/or anti-neoplastic agents within 90
 days prior to baseline.

 12. Subjects who have unstable medical disorders that are clinically significant or have
 lifethreateningdiseases.

 13. Subjects who have on-going malignancies requiring systemic treatment will be excluded
 from study participation. In addition, Subjects who have any malignancy of the skin of
 the facial area will also be excluded.

 14. Subjects who engage in activities that involve excessive or prolonged exposure to
 sunlight or weather extremes, such as wind or cold.

 15. Subjects who consume excessive amounts of alcohol (greater than two drinks per day) or
 of drugs of abuse (including, but not limited to, cannabinoids, cocaine and
 barbiturates).

 16. Subjects who have participated in an investigational drug study (i.e., Subjects have
 been treated with an investigational drug) within 30 days prior to baseline will be
 excluded from study participation. Subjects who are participating in non-treatment
 studies such as observational studies or registry studies can be considered for
 inclusion.

 17. Subjects who have been previously enrolled in this study.

 18. Subjects who have had laser therapy, electrodesiccation and phototherapy (e.g.,
 ClearLight®) to the facial area within 180 days prior to study entry.

 19. Subjects who have had cosmetic procedures (e.g., facials) which may affect the
 efficacy and safety profile of the investigational product within 14 days prior to
 study entry. Cosmetic procedures and facials are prohibited throughout the study.

 20. Subjects who currently have or have recently had bacterial folliculitis on the face.

 21. Subjects with a baseline irritation score of 3 = severe (marked, intense).

 22. Subjects with known G6PD deficiency, or congenital or idiopathic methemoglobinemia.