A 6% Benzoyl Peroxide Foaming Cloth Cleanser Used in the Treatment of Acne Vulgaris: Aesthetic Characteristics, Patient Preference Considerations, and Impact on Compliance with Treatment

| July 3, 2009

James Q. Del Rosso, DO, FAOCD
Valley Hospital Medical Center, Las Vegas, Nevada

Abstract
Objective: The study was conducted to evaluate the product attributes of a new benzoyl peroxide-containing foaming cloth cleanser and to compare the overall patient satisfaction of this product with two currently available benzoyl peroxide acne products (6% benzoyl peroxide cleanser and 4% benzoyl peroxide wash). Design: This was a randomized, single-blind study. Setting: Two clinical trial sites. Participants: Male and female subjects (N=193) aged 17 to 30 years with a history of acne vulgaris were enrolled. Measures: Subjects initially cleansed their face with the benzoyl peroxide foaming cloth and then completed a product-attribute survey. Following an interval of five minutes or more, subjects cleansed their face again using one of two randomly assigned comparator benzoyl peroxide-containing cleansing products and then completed a comparative survey. Survey results were tabulated and a top-two box analysis was performed. Results: Following the use of the benzoyl peroxide-containing foaming cloth, 94 percent of the product-attribute responses were positive (p?0.05). With respect to convenience, usability, and cosmetic elegance, the majority of subjects indicated a preference for the benzoyl peroxide foaming cloth compared to the 6% benzoyl peroxide cleanser and 4% benzoyl peroxide wash (for each, p?0.05). There were no reports of adverse events. Conclusion: These attributes supporting preference for the benzoyl peroxide foaming cloth cleanser may improve patient satisfaction with topical acne treatment resulting in improved patient compliance.  (J Clin Aesthetic Dermatol. 2009;2(7):26–29.)

Acne vulgaris is the most common skin disorder in the United States with a prevalence of 70 to 85 percent among adolescents and an overall incidence of approximately 17 million people.[1,2] As many as 25 percent of adolescents may suffer from permanent acne scarring by the time they reach 18 years of age.[3] In addition to physical disfigurement, acne vulgaris may be responsible for significant emotional and psychological distress, and can negatively impact social functioning and overall quality of life.[2,4,5] Although a variety of systemic and topical therapies are available, an estimated 10 to 15 percent or more of patients fail to respond to treatment, largely because of poor adherence with prescribed therapy.[6,7] Reasons for noncompliance are varied but include dissatisfaction with available drug therapy.[1,7–9]

The treatment of mild-to-moderate acne vulgaris usually begins with topical therapy.10 Products containing benzoyl peroxide (BPO) and retinoids may be used for long periods and are the mainstay of maintenance therapy.[11] BPO is an effective antibacterial agent and has also been shown to decrease the emergence of antibiotic-resistant strains of Propionibacterium acnes (P. acnes) when used together with topical antibiotics.[10] Currently available BPO-containing acne product formulations include creams, gels, lotions, and washes in concentrations ranging from 2.5 to 10 percent.
In an effort to improve patient satisfaction and thereby increase patient compliance with topical BPO therapy, a foaming cloth containing a cleanser-based formulation of 6% BPO has been developed. The purpose of the following study was to evaluate the product attributes of this new BPO foam-ing cloth cleanser and to compare overall patient satisfaction of this product with two commercially available BPO cleansers.

Methods
This randomized, single-blind study enrolled male and female subjects aged 17 to 30 years at two study centers. Eligibility for trial enrollment was based on responses to a health questionnaire completed by each study candidate. Written informed consent was obtained from each subject prior to performing any aspect of the study. The protocol and informed consent agreements were reviewed and approved by an independent institutional review board.

The subjects enrolled in the study were required to have a history of facial acne or self perceived facial acne. Subjects were excluded from participation in the study if they had known allergies or sensitivities to topical facial wash products including benzoyl peroxide or other acne treatments; were participating in studies with other facial products; or were pregnant, nursing or planning to become pregnant within six months following enrollment.

Each subject initially cleansed his or her face with the BPO foaming cloth. Specifically, subjects were instructed to wet the foaming cloth with a light stream of tap water, lather and gently wash their face without scrubbing, then rinse thoroughly and pat dry. Following a minimum of five minutes, each subject cleansed his or her face again using one of two randomly assigned comparator BPO-containing cleansing products: a 6% BPO cleanser or a 4% BPO wash. Subjects were instructed to lightly wet their hands and face with water, dispense about a dime-size amount of either product, lather in their hands, apply the product to their face as they would if using their normal cleanser, rinse thoroughly, and pat dry.

This study was completed in a single session. After washing with the BPO foaming cloth, each subject completed a 17-item survey regarding various attributes of the product. After washing with one of the comparator BPO-containing cleansing products, each subject completed an 11-point comparative survey. Subjects rated their agreement with survey statements using a five-point scale ranging from 1 (strongly agree) to 5 (strongly disagree).

The survey results were tabulated and a top-two box analysis was performed. Using this method, the number of top two positive responses (responses with scores of 1 or 2) was compared with the number of the top two negative responses (responses with scores of 4 or 5) for each questionnaire statement. Statistical significance was established at p?0.05.

Results
Among the subjects enrolled in the trial (N=193), most were female (N=124) aged 17 to 22 years (N=141). Subject demographics obtained from health questionnaires completed by enrolled subjects are provided in Table 1. All subjects completed the study with no reports of adverse events. The analysis of BPO foaming cloth attributes is presented graphically in Figure 1. The responses to 15 of the 16 questions shown were positive. In addition, the responses to Question 17 (not shown) “When would you use the cleansing cloth?” were: at the sink (33.1%), in the shower (15.0%), or both (51.8%). Overall, 16 of 17 responses were positive (94%; p?0.05).

The comparison of the 6% BPO foaming cloth with the 6% BPO wash and 4% BPO cleanser are provided in Figures 2 and 3, respectively. The qualities of the BPO foaming cloth were found to be significantly superior (p?0.05) to the 6% BPO Cleanser in all 11 questions (100%). The BPO foaming cloth was also found to be significantly superior (p?0.05) to the 4% BPO wash in 10 of the 11 questions (90.9%). Although the number of responses was numerically superior, statistical significance was not reached for the question regarding the ability of the foaming cloth to provide more lather to cover face, chest, back, and trunk.

Discussion
The results of this study indicate a new foaming cloth cleanser formulation containing 6% BPO has several attributes that appear to provide advantages over the two comparator BPO-containing acne cleanser products. The subjects in this study consistently provided positive response for questions related to convenience (Questions 1–5), usability (Questions 6–12), and cosmetic elegance (Questions 13–16). The most favorable responses were that the foaming cloth provided enough lather to cover face (92.7%), was portable (92.2%), left my face feeling clean (90.6%), cleansed my face very well (87.0%), and was easy to use at the sink (87.0%).

Although the study only instructed that the patients wash their faces, subjects also reported that the product provided an adequate amount of foam to cleanse the face, chest, and back; however, a substantial number of subjects indicated that the foam produced by one cloth was not sufficient for cleansing all three areas of the body. The survey results indicate the amount of available foam was the least favorable attribute of the product. The final item of the product-attribute questionnaire addressed product preference as it relates to mobility and versatility. Patient responses indicate that the foaming cloth is suitable for use at the sink, in the shower, or both.

The responses to Questions 1 to 3 of the comparator survey indicate that the foaming cloth is easier to use than the 6% BPO cleanser and 4% BPO wash. Questions 4 to 10 indicate it is aesthetically superior to either formulations of BPO cleanser or wash. Based on the responses to Question 11, nearly 80 percent of the subjects in this study preferred the foaming cloth over the 6% BPO cleanser and 4% BPO wash products.

Overall, the BPO foaming cloth was preferred over the 6% BPO cleanser. The most favorable characteristics of the foaming cloth versus BPO 6% cleanser were: more portable (97.9%), more adequate amount of lather (87.6%), produced more lather to cover face (86.5%), lather/foam was more appealing (83.5%), and produced more lather to cover chest and back (for each, 81.4%). Similarly, the BPO foaming cloth was found to be preferable to the 4% BPO wash. The most favorable characteristics of the foaming cloth versus 4% BPO wash were: more portable (94.7%), lather/foam was more appealing (80.2%), more convenient to use (80.2%), the product they preferred (78.1%), and more cosmetically elegant (77.0%).
Together, these results suggest that patient preference is higher for the BPO-containing foaming cloth because it is convenient, portable, and pleasant to use compared to the two existing topical BPO cleanser products tested. In addition to improved patient satisfaction with topical BPO treatment, these features may result in increased patient adherence.

Conclusion
The results of this patient preference study suggest that a novel BPO-containing foaming cloth cleanser has several desirable attributes that make it superior to currently available topical BPO acne cleanser products tested in terms of patient preference. Specifically, the subjects in this study consistently reported the product cleansed well, washed off easily, and was cosmetically elegant. Enhanced patient satisfaction may be an important step toward improving patient adherence with topical acne therapy.

Acknowledgment
This study was sponsored by Medicis Pharmaceutical Corporation.

References
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Category: Acne, Original Research, Past Articles

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