Study Comparing Test to Aczone 7.5% and Both 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 diagnosisof acne vulgaris.

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

3. Subjects must have a minimum ≥ 25 non-inflammatory lesions (i.e., open and closedcomedones) AND ≥ 20 inflammatory lesions (i.e., papules and pustules) AND ≤ 2nodulocystic lesions (i.e., nodules and cysts), at baseline on the face. For thepurposes of study treatment and evaluation, these lesions should be limited to thefacial treatment area. All lesions will be counted, including those present on thenose. Subjects may have acne lesions on other areas of the body which will also beexcluded 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 orantibiotics during the 12-week treatment period for acne vulgaris, other than theInvestigational 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 anegative urine pregnancy test, must be willing to use an acceptable form of birthcontrol during the study from the day of the first dose administration to 30 daysafter the last administration of study drug . For the purpose of this study thefollowing are considered acceptable methods of birth control: oral or injectablecontraceptives, contraceptive patches, Depo-Provera® (stabilized for at least 3months) NuvaRing® (vaginal contraceptive);Implanon™ (contraceptive implant), doublebarrier methods (e.g. condom and spermicide),Intrauterine Device (IUD), Essure, orabstinence. 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 partneris NOT considered an adequate form of birth control. Hormonal contraceptives shouldnot be initiated or changed during the study.

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

8. Subjects must be willing and able to understand and comply with the requirements ofthe 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 ofacne 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 eruptionscaused 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 minimumperiod of 14 days prior to study entry and must agree to not change make-up brand/typeor frequency of use throughout the study.

Exclusion Criteria:

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

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

3. Subjects with the presence of any skin condition that would interfere with thediagnosis 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.) thatwould interfere with diagnosis or assessment of acne vulgaris.

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

6. Subjects who have used within 6 months prior to baseline or use during the study oforal 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 priorto 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 monthprior to baseline or use during the study:

9. cryodestruction or chemodestruction,

10. dermabrasion,

11. photodynamic therapy,

12. acne surgery,

13. intralesional steroids, or

14. X-ray therapy.

15. Subjects who have used any of the following treatments within 1 month prior tobaseline or during the study:

16. systemic steroids,

17. spironolactone,

18. systemic antibiotics,

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

20. systemic anti-inflammatory agents

21. Subjects who have used any of the following treatments within 2 weeks prior tobaseline or during the study:

22. topical steroids,

23. topical retinoids,

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

25. topical anti-inflammatory agents, or

26. topical antibiotics.

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

28. Subjects who have unstable medical disorders that are clinically significant or havelifethreateningdiseases.

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

30. Subjects who engage in activities that involve excessive or prolonged exposure tosunlight or weather extremes, such as wind or cold.

31. Subjects who consume excessive amounts of alcohol (greater than two drinks per day) orof drugs of abuse (including, but not limited to, cannabinoids, cocaine andbarbiturates).

32. Subjects who have participated in an investigational drug study (i.e., Subjects havebeen treated with an investigational drug) within 30 days prior to baseline will beexcluded from study participation. Subjects who are participating in non-treatmentstudies such as observational studies or registry studies can be considered forinclusion.

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

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

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

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

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

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