A Safety and Efficacy Evaluation of Topical Treatments for Moderate-Severe Facial Acne Vulgaris

Inclusion Criteria:

1. Males or females 12 to 45 years of age, inclusive, in good general health.

2. Clinical diagnosis of facial acne vulgaris

3. Patients with an Investigator's Global Assessment severity score of at least 3 that
meet the following lesion count criteria:

- A minimum of 20 but not more than 50 inflammatory lesions (including the nose)

- A minimum of 30 but not more than 100 non-inflammatory lesions on the face
(including the nose)

- No nodules are allowed on the entire face.

4. Each patient or parent/guardian will read and sign the consent form as required by IRB
regulations. Patients under the age of 18, but of sufficient age to provide assent (as
determined by IRB regulations), will complete an assent form.

5. Female patients of childbearing potential must have a negative urine pregnancy test
prior to receiving study medication.

6. Treatment with estrogens, androgens, or anti-androgenic agents for a non-contraceptive
indication must be stable for 6 months prior to the first dose of study product and
remain unchanged during the study.

7. Patients who are willing and able to follow all study procedures, attend all scheduled
visits, and successfully complete the study.

8. Patients who are mentally competent in the Investigator's judgment, to provide
informed consent/assent to participate in the study

Exclusion Criteria:

1. Patients who had been treated with:

- systemic retinoids during a 6-month period before Visit 1 or by systemic
antibiotics during a 4-week period before Visit 1

- or by a topical treatment (eg, antibiotics, benzoyl peroxide, retinoids, azelaic
acid, resorcinol, salicylates, sulfacetamide sodium and derivatives, glycolic
acid, dapsone) or systemic corticosteroids during a 2-week period before the
first dose of study medication.

2. History of hereditary angio-edema

3. Pregnancy, lactation or patient, who is not practicing effective contraception.

4. Any clinically relevant finding at their baseline physical examination or
dermatological medical history such as severe systemic diseases or diseases of the
facial skin.

5. A known endocrine malfunction (hyperthyroidism, hypothyroidism, diabetes, adrenal
insufficiency).

6. Erythroderma, immunodeficiency disorders and Mycosis Fungoides

7. History of Epilepsy or Parkinson's disease

8. History of alcohol and/or drug abuse within 5 years of screening

9. Facial hair (beard), excessive scarring, sunburn or other disfigurement that may
obscure the accurate assessment of acne grade

10. Any single facial skin condition assessment graded as "Severe" at Visit 1

11. Using drugs known to be photosensitizers because of the possibility of increased
phototoxicity.

12. Refusal to cease using the following types of facial products: astringents, toners,
abradants, facials, loofahs, peels containing glycolic or other acids, masks, washes
or soaps containing benzoyl peroxide (BPO), hydroquinone, sulfacetamide sodium or
salicylic acid, non-mild facial cleansers, or moisturizers that contain retinol,
salicylic acid, or α- or β-hydroxy acids .

13. Using medications that are reported to exacerbate acne .

14. Have had a facial procedure (chemical or laser peel, microdermabrasion, artificial
ultraviolet therapy) performed by an esthetician, beautician, physician, nurse, or
other practitioner, during the 4 weeks prior to Visit 1.

15. Unwilling to avoid excessive swimming and sun exposure to include artificial UV light
exposure (tanning beds).

16. Patients using comedogenic makeup.

17. Have a known hypersensitivity or previous allergic reaction to any of the components .

18. Employees of the clinical research site or organization involved in the study, or an
immediate family member (partner, offspring, parents, siblings, or sibling's
offspring) of an employee.

19. Have a member of the same household in this trial.

20. Patients who have participated in an investigational clinical, surgical, drug, or
device study within the past 30 days

21. Patients who, in the opinion of the investigator, should not be included in the study
for any reason, including inability to follow study procedures

22. Patients who withdraw consent before completion of Visit 1 procedures