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

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 the efficacy and tolerability of MAXCLARITY II, an over the
      counter, topical benzoyl peroxide (BPO) product line, in subjects with acne.

      This is a multi center, open label study to evaluate the efficacy and tolerability of
      MAXCLARITY II, an over the-counter, topical benzoyl peroxide product line, in subjects with
      acne. Approximately 30 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 will complete counts of inflamed lesions (papules/pustules) and noninflamed
      lesions (open/closed comedones), the ISGA, and an assessment of tolerability at each study
      visit. Subjects will assess tolerability 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.
    

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
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Available over the counter.; Available over the counter.; Available over the counter.
Intervention MeSH terms: Salicylic Acid; Salicylates
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment