Article

A multicenter efficacy and tolerability evaluation of benzoyl peroxide in a 10% urea vehicle for the treatment of acne vulgaris.

Gold Skin Care Center/Tennessee Clinical Research Center, Nashville 37215, USA.
Journal of drugs in dermatology: JDD (Impact Factor: 1.45). 06/2006; 5(5):442-5.
Source: PubMed

ABSTRACT

Acne vulgaris is a common skin disease that affects 70 to 96% of individuals. Topical benzoyl peroxide has been used successfully for acne treatment; however, it may be accompanied by drying and or flaking skin. The addition of a 10% urea to the product excipient is theorized to moisturize the skin due to its humectant properties, aid in the efficacy of benzoyl peroxide due to its keratolytic properties, and effectively combat Propionibacterium acnes due to its antibacterial properties.
To assess the efficacy and tolerability of the treatment of acne vulgaris with multiple strengths of benzoyl peroxide in a 10% urea vehicle gel or cream and cleanser. Methods: A multicenter, non-randomized, open-label study in which 1,089 patients with acne vulgaris were enrolled at 133 participating physician office sites. Qualifying and consenting patients were prescribed either 4.5% or 8.5% benzoyl peroxide in a 10% urea vehicle cream or gel and cleanser. Additional medications were permitted during the study with the exception of those containing benzoyl peroxide. The physician assessed lesion counts, both inflammatory and non-inflammatory, at baseline and Week 4. Dryness and erythema were rated by the physician on a scale from 0 (none) to 8 (severe or deep) at baseline and Week 4.
Nine hundred sixty-three patients completed the study. The following significant treatment arms were analyzed: patients treated with 4.5%/8.5% benzoyl peroxide in a 10% urea vehicle product only, patients treated with 4.5%/8.5% benzoyl peroxide in a 10% urea vehicle products along with oral doxycycline, and patients treated with 4.5%/8.5% benzoyl peroxide in a 10% urea vehicle products along with oral minocycline. A 44% (n=567) mean reduction in total lesion count was observed after 4 weeks of treatment with 4.5%/8.5% benzoyl peroxide in a 10% urea vehicle products only. Dual therapy using oral doxycycline (n=17) proved to be even more effective with a significant mean reduction in lesion count of 52% after only 4 weeks of treatment. Dual therapy using oral minocycline (n=21) yielded a significant mean reduction in lesion count of 34% after 14 weeks of treatment. The overall tolerability of the treatment illustrated the utility of urea as a moisturizing agent.
Benzoyl peroxide in a 10% urea vehicle gel or cream and cleanser, used once daily for 4 weeks was found to be both effective and well tolerated for the treatment of symptoms related to acne vulgaris.

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    ABSTRACT: Antibiotic resistance of Propionibacterium acnes (P. acnes) is a growing phenomenon in the wake of widespread use of topical and systemic antibiotics for acne vulgaris. Benzoyl peroxide has a proven track record of safety and efficacy, and can decrease reliance on antibiotics in the treatment of acne. To review the literature for methods to increase the efficacy and tolerability of benzoyl peroxide (BPO). A PubMed literature search was done using the terms "benzoyl peroxide," "vehicle," "mechanism," and "delivery system." Relevant papers were reviewed for methods of increasing BPO efficacy and tolerability. BPO in concentrations of 2.5%, 5% and 10% are equally effective at treating inflammatory acne. However, higher concentrations are associated with more adverse effects. The efficacy of BPO may be enhanced by the presence of Vitamin E and tertiary amines. BPO is also more efficacious if used in combination with topical retinoids than as a monotherapy. Novel vehicles including a microparticle delivery system and those with a hydrophase or urea base increase the tolerability of BPO without sacrificing efficacy. Benzoyl peroxide has a proven track record of safety and efficacy for the treatment of acne. Recent discoveries have provided new methods of increasing the efficacy and tolerability of topical BPO, making it useful as monotherapy for mild acne or as an adjunct in the treatment of moderate to severe acne vulgaris.
    No preview · Article · Aug 2009 · Journal of drugs in dermatology: JDD
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    No preview · Article · Jan 2012 · American Journal of Clinical Dermatology
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