U0289-402: An Open Label, 8 Week Study to Evaluate the Efficacy and Tolerability of MAXCLARITY II in Subjects With Acne
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: MAXCLARITY II (2.5% BPO) Foam Cleanser; MAXCLARITY II (2.5% BPO) Foam Treatment; MAXCLARITY II (0.5% Salicylic Acid) Toner Foam
Intervention description: Available over the counter.; Available over the counter.; Available over the counter.
Intervention MeSH terms: Salicylic Acid; Salicylates
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: All
Minimum age: 16 Years
Maximum age: 29 Years
Healthy volunteers: No

Summary:

      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 the efficacy and tolerability of MAXCLARITY II, an over the
      counter, topical benzoyl peroxide (BPO) product line, in subjects with acne.
    

Eligibility criteria:

        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 24 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.