8 Week Study to Evaluate and Compare the Efficacy and Tolerability of MAXCLARITY II and MURAD To Treat Acne
8 Week Study to Evaluate and Compare the Efficacy and Tolerability of MAXCLARITY II and MURAD To Treat Acne
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 product lines for the treatment of acne: MAXCLARITY II Foam Cleanser (2.5%
 benzoyl peroxide [BPO]) plus Foam Treatment (2.5% BPO) and (0.5% Salicylic Acid) Toner Foam
 compared with MURAD Clarifying Cleanser (1.5% salicylic acid [SA]) plus Exfoliating Acne
 Treatment Gel (1% SA) and Skin Perfecting Lotion.
Acne vulgaris (acne) is an extremely common dermatological disease that is found typically in
 adolescence and young adulthood. Acne manifests with open and closed comedones (blackheads
 and whiteheads), papules, pustules, nodules, and cysts on the face, neck, and trunk. Acne 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 [SA]
 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. Salicylic acid has comedolytic properties and is
 often used when other topical therapies are not tolerated. Benzoyl peroxide and SA are
 frequently the first products that adolescents will use for acne because both 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 over the
 counter, topical product lines for the treatment of acne: MAXCLARITY II Foam Cleanser (2.5%
 benzoyl peroxide [BPO]) plus Foam Treatment (2.5% BPO) and (0.5% Salicylic Acid) Toner Foam
 compared with MURADClarifying Cleanser (1.5% salicylic acid [SA]) plus Exfoliating Acne
 Treatment Gel (1% SA) and Skin Perfecting Lotion.

 This is a randomized, single center, evaluator blinded, split face efficacy and tolerability
 study of MaxClarity II and Murad, 2 over the-counter, topical product lines for the treatment
 of acne. Approximately 20 subjects, aged from 16 to 29 years, inclusive, with mild facial
 acne 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 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 1, week 2,
 week 4 and week 8. Only the expert grader (evaluator) will be blinded to the study product
 assignments; subjects and study nurses/coordinators 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, characterized by at least 12 facial inflammatory lesions (papules
 and pustules) and/or noninflammatory lesions (open and closed comedones) on each half
 of the face (excluding nose and front hairline areas).

 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 an active or chronic skin allergy.

 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.

 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.

 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.