U0289-401: Eight Week, Split-face, Study to Determine and Compare the Efficacy and Tolerability of MAXCLARITY™ II to PROACTIV™
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 4

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 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.
    

Detailed description: 
      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.
    

Intervention name(s): MAXCLARITY II (2.5% BPO) Foam Cleanser; MAXCLARITY II (2.5% BPO) Foam Treatment; MAXCLARITY II (0.5% Salicylic Acid) Toner Foam; PROACTIV (2.5% BPO) Renewing Cleanser; PROACTIV (2.5% BPO) Repairing Lotion; PROACTIV (2.5% BPO) Revitalizing Toner
Intervention type(s): Other; Other; Other; Other; Other; Other
Intervention description(s): Available over the counter.; Available over the counter.; Available over the counter.; Available over the counter.; Available over the counter.; Available over the counter.
Intervention MeSH terms: Salicylic Acid; Salicylates
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment