NCT01706263

U0289-402: An Open Label, 8 Week Study to Evaluate the Efficacy and Tolerability of MAXCLARITY II in Subjects With Acne

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Stiefel, a GSK Company · Industry
• Sex: All
• Age: 16 Years – 29 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	MAXCLARITY II (2.5% BPO) Foam Cleanser	Available over the counter.
DRUG	MAXCLARITY II (2.5% BPO) Foam Treatment	Available over the counter.
DRUG	MAXCLARITY II (0.5% Salicylic Acid) Toner Foam	Available over the counter.

Timeline

• Start date: 2009-08-01
• Primary completion: 2009-11-20
• Completion: 2009-11-20
• First posted: 2012-10-15
• Last updated: 2018-01-08
• Results posted: 2018-01-08