8 Week Study to Evaluate and Compare the Efficacy and Tolerability of MAXCLARITY II and MURAD To Treat 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 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.
    

Detailed description: 
      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.
    

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; MURAD Clarifying Cleanser (1.5% SA); Exfoliating Acne Treatment Gel (1% SA); Skin Perfecting Lotion
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; Benzoyl Peroxide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment