U0289-401: Eight Week, Split-face, Study to Determine and Compare the Efficacy and Tolerability of MAXCLARITY™ II to PROACTIV™
U0289-401: Eight Week, Split-face, Study to Determine and Compare the Efficacy and Tolerability of MAXCLARITY™ II to PROACTIV™
One of the main success factors in acne therapy is user compliance with treatment, product
 cost, availability and ease of use. Poor compliance may translate into decreased efficacy
 (either not improving symptoms well enough or not improving symptoms fast enough),
 tolerability issues or adverse effects (eg, erythema, dryness, or peeling of the skin), a
 lack of understanding of the instructions for use, or product cost/availability. Whatever the
 reason, poor compliance translates to decreased efficacy and increased frustration on the
 part of the user.

 The current study will evaluate and compare the efficacy and tolerability of 2
 over-the-counter, topical benzoyl peroxide (BPO) product lines in subjects with acne:
 MAXCLARITY II (2.5% BPO) Foam Cleanser and Foam Treatment and (0.5% Salicylic Acid) Toner
 Foam compared with PROACTIV (2.5% BPO) Renewing Cleanser and Repairing Lotion and
 Revitalizing Toner.
Acne vulgaris is an extremely common dermatological disease that is found typically in
 adolescence and young adulthood. Acne vulgaris manifests with open and closed comedones
 (blackheads and whiteheads), papules, pustules, nodules, and cysts on the face, neck, and
 trunk. Scarring can occur, particularly if the lesions are inflamed and deep, even in the
 absence of external manipulation (eg, picking and squeezing) of the skin.

 Acne vulgaris can be treated with a variety of agents that are selected to address the
 pathogenic factors assumed to be responsible for the type and degree of manifested acne
 lesions. Monotherapy and combination therapy regimens are both useful. Topical agents are
 generally used as first-line therapy and include retinoids, antibiotic preparations (eg,
 erythromycin and clindamycin), benzoyl peroxide (BPO), alpha and beta hydroxy acids (eg,
 glycolic and salicylic acid preparations), and azelaic acid. Systemic therapies are initiated
 in patients with moderate to severe inflammatory acne that does not respond to topical
 therapy.

 Benzoyl peroxide has antimicrobial and anti inflammatory properties and is often considered
 an important component of acne treatment. Benzoyl peroxide is frequently the first product
 that adolescents will use for acne because it can be purchased without a prescription in
 several different concentrations and formulations.

 One of the main success factors in acne therapy is user compliance with treatment, product
 cost, availability and ease of use. Poor compliance may translate into decreased efficacy
 (either not improving symptoms well enough or not improving symptoms fast enough),
 tolerability issues or adverse effects (eg, erythema, dryness, or peeling of the skin), a
 lack of understanding of the instructions for use, or product cost/availability. Whatever the
 reason, poor compliance translates to decreased efficacy and increased frustration on the
 part of the user.

 The current study will evaluate and compare the efficacy and tolerability of 2 common,
 over-the-counter, topical benzoyl peroxide (BPO) product lines in subjects with acne:
 MAXCLARITY II (2.5% BPO) Foam Cleanser and Foam Treatment and (0.5% Salicylic Acid) Toner
 Foam compared with PROACTIV(2.5% BPO) Renewing Cleanser and Repairing Lotion and Revitalizing
 Toner.

 This is a randomized, 2 center, evaluator-blinded, split-face efficacy and tolerability study
 of MAXCLARITYII and PROACTIV, 2 over-the-counter, topical benzoyl peroxide product lines, in
 subjects with acne. Approximately 40 subjects, aged from 16 to 29 years, inclusive, with mild
 facial acne vulgaris are expected to participate in the study. No more than 50% of the
 subjects at each site can be enrolled under the age of 20.

 An expert grader (blinded evaluator) will complete counts of inflamed lesions
 (papules/pustules) and noninflamed lesions (open/closed comedones), the Investigator's Static
 Global Assessment (ISGA), and an assessment of tolerability of each side of the face at each
 study visit. Subjects will assess tolerability on each side of the face at each study visit
 and will complete a product acceptability and preference questionnaire at the end of the
 study.

 The study duration will be 8 weeks (56 days) with visits at baseline (day 1), week 1m week 2,
 week 4 and week 8. Only the expert grader (evaluator) will be blinded to the study product
 assignments; subjects and study nurses/coordinator will not be blinded.
Inclusion Criteria:

 1. Capable of understanding and willing to provide signed and dated written voluntary
 informed consent (and any local or national authorization requirements) before any
 protocol 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 12 facial inflammatory lesions
 (papules and pustules) and/or noninflammatory lesions (open and closed comedones) on
 the face.

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

 5. Sexually active females of childbearing potential participating in the study must
 agree to use a medically acceptable method of contraception while receiving
 protocol-assigned product. A woman of childbearing potential is defined as one who is
 biologically capable of becoming pregnant; including perimenopausal women who are less
 than 2 years from their last menses. Acceptable contraceptive methods include the
 following:

 -  Hormonal contraception, including oral, injectable, or implantable methods
 started at least 2 months prior to screening. If hormonal contraception was
 started less than 2 months prior to screening, then a form of nonhormonal
 contraception should be added until the third continuous month of hormonal
 contraception has been completed.

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

 -  Women who are not currently sexually active must agree to use a medically
 accepted method of contraception should she become sexually active while
 participating 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 the
 risk 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 of
 the baseline visit.

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

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

 10. Currently using any medication that in the opinion of the investigator may affect the
 evaluation of the study products or place the subject at undue risk (including but not
 limited to asthma medications, oral steroids, rifampin, anticonvulsants, and St John's
 wart).

 11. Has a history of known or suspected intolerance to any of the ingredients of the study
 products (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 Stiefel
 Laboratories who is involved in the study, or an immediate family member (partner,
 offspring, parents, siblings or sibling's offspring) of an employee involved in the
 study.