U0289-402: An Open Label, 8 Week Study to Evaluate the Efficacy and Tolerability of MAXCLARITY II in Subjects With Acne

Inclusion Criteria:

1. Capable of understanding and willing to provide signed and dated written voluntaryinformed consent (and any local or national authorization requirements) before anyprotocol specific procedures are performed.

2. Male or female aged from 16 to 29 years, inclusive, at time of consent. No more than 50% of the subjects at each site can be enrolled under the age of 20.

3. Mild facial acne vulgaris, characterized by at least 24 facial inflammatory lesions (papules and pustules) and/or noninflammatory lesions (open and closed comedones) onthe face.

4. Able to complete the study and to comply with study instructions.

5. Sexually active females of childbearing potential participating in the study mustagree to use a medically acceptable method of contraception while receivingprotocol-assigned product. A woman of childbearing potential is defined as one who isbiologically capable of becoming pregnant; including perimenopausal women who are lessthan 2 years from their last menses. Acceptable contraceptive methods include thefollowing:

• Hormonal contraception, including oral, injectable, or implantable methodsstarted at least 2 months prior to screening. If hormonal contraception wasstarted less than 2 months prior to screening, then a form of nonhormonalcontraception should be added until the third continuous month of hormonalcontraception has been completed.

• Two forms of reliable nonhormonal contraception, to include the use of either anintrauterine device plus a reliable barrier method or 2 reliable barrier methods.Reliable barrier methods include condoms or diaphragms. A cervical cap is also areliable barrier method, provided that the female subject has never given birthnaturally. The combined use of a condom and spermicide constitute 2 forms ofacceptable nonhormonal contraception, provided that they are both used properly.The use of spermicide alone and the improper use of condoms are inferior methodsof contraception. Subjects with surgical sterilization, including tubalsterilization or partner's vasectomy, must use a form of nonhormonalcontraception. A barrier method or sterilization plus spermatocide is acceptable.

• Women who are not currently sexually active must agree to use a medicallyaccepted method of contraception should she become sexually active whileparticipating in the study.

Exclusion Criteria:

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

2. Has active or chronic skin allergies.

3. Has a history of acute or chronic disease that might interfere with or increase therisk of study participation.

4. Had skin cancer treatment in preceding 12 months.

5. Has damaged skin on facial areas (eg, sunburn, tattoo, or scar)

6. Had any medical procedure (eg, laser resurfacing, chemical peel, or plastic surgery)on facial areas in preceding 12 months.

7. Had any cosmetic procedure (eg, microdermabrasion) on facial areas within 8 weeks ofthe baseline visit.

8. Has any dermatological disorder that in the opinion of the investigator may interferewith the accurate evaluation of the subject's facial appearance.

9. Received any investigational drug or procedure within 28 days of the baseline visit oris scheduled to receive an investigational drug (other than the study products) orprocedure during the study.

10. Currently using any medication that in the opinion of the investigator may affect theevaluation of the study products or place the subject at undue risk (including but notlimited to asthma medications, oral steroids, rifampin, anticonvulsants, and St John'swart).

11. Has a history of known or suspected intolerance to any of the ingredients of the studyproducts (ie, benzoyl peroxide).

12. Considered unable or unlikely to attend the necessary visits.

13. Live in the same household as currently enrolled subjects.

14. Employee of the investigator, a contract research organization, or StiefelLaboratories who is involved in the study, or an immediate family member (partner,offspring, parents, siblings or sibling's offspring) of an employee involved in thestudy.