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Positive results of an open-label, multicenter trial support the use of a gel body wash containing 0.006 percent sodium hypochlorite (CLn Body Wash, Top MD Skin Care) as an adjunct in the management of atopic dermatitis (AD), according to researchers who presented their findings at the 2014 annual meeting of the American Academy of Dermatology.
Denver - Positive results of an open-label, multicenter trial support the use of a gel body wash containing 0.006 percent sodium hypochlorite (CLn Body Wash, Top MD Skin Care) as an adjunct in the management of atopic dermatitis (AD), according to researchers who presented their findings at the 2014 annual meeting of the American Academy of Dermatology.
The study recruited pediatric patients from the outpatient dermatology clinics of the University of Texas Health Science Center, Houston, and Northwestern University Feinberg School of Medicine, Chicago. Eligible criteria required presence of moderate-to-severe AD and culture-confirmed Staphylococcus aureus colonization of affected skin without active infection. Patients were to use the gel body wash daily in the bath or shower with instructions to lather it on and wait one to two minutes before rinsing. Existing treatments for atopic dermatitis were continued unchanged during the six-week study.
Forty patients were enrolled (mean age 8.5 years) in the study. Changes in the Investigator’s Global Assessment, Eczema Area and Severity Index score, pruritus visual analogue scale, and body surface area of involvement were assessed to determine benefit. At a follow-up visit after two weeks, all of these standard parameters of AD severity as well as measures of quality of life (Children’s Dermatology Life Quality Index and Family Dermatology Life Quality Index) showed statistically significant improvements from baseline.
Further benefit was observed at the six-week follow-up. At study completion, scores for all of the endpoints had improved by between 34 and 44 percent from baseline. In addition, the product was well-received, particularly by patients who were poorly compliant with previous recommendations on using bleach baths, researchers noted.
“We established in a previous randomized, double-blind study (Huang JT, et al. Pediatrics. 2009;123(5):e808-e814) that dilute bleach baths can be very helpful in decreasing the severity of AD in patients with clinical signs of secondary bacterial infections, and this modality has become an important part of our recommended strategy for maintaining disease control,” says Amy S. Paller, M.D., principal investigator and Chair and Walter J. Hamlin Professor of Dermatology, Northwestern University Feinberg School of Medicine, Chicago. “However, not all households have bathtubs, and not everyone likes to take baths. In particular, older children, teens, and adults generally prefer showering over baths.”
The study results reflect findings from another, smaller trial, Dr. Paller says.
“The positive results of our study are consistent with those from a previous smaller open-label trial conducted by Fred Ghali, M.D., and colleagues (Ryan C, et al. Pediatr Dermatol. 2013;30(3):308-315), and together they indicate the sodium hypochlorite body wash offers a convenient alternative for extending the benefits of bleach baths to a broader population,” she says.
Dr. Paller notes that when the body wash is diluted with water for lathering, the concentration of sodium hypochlorite on exposed skin is similar to that achieved in a commonly recommended regimen for preparing a dilute bleach bath (one-fourth cup household bleach per half tub of water).
Further research is needed to determine the underlying mechanism(s) for the benefits of topical sodium hypochlorite in patients with atopic dermatitis.
“In addition to being antimicrobial, a recently published paper describing results from a series of preclinical studies indicates that sodium hypochlorite has anti-inflammatory effects mediated by modulation of nuclear factor-kappaB signaling (Leung TH, et al. J Clin Invest. 2013(12):5361-5370),” Dr. Paller says.
Dr. Paller reiterates that the role of dilute bleach baths or use of the sodium hypochlorite body wash in AD patient management is as an adjunct in maintenance care for certain patients.
“The skin of most patients with AD is colonized with S. aureus, but bleach can be especially helpful for those who have a tendency to develop infections or crusting in areas prone to scratching. The body wash or dilute bleach baths are important as maintenance therapy rather than just for acute flares,” Dr. Paller says.
Disclosures: Top MD Skin Care provided funding for the research. Dr. Paller reports no other relevant financial interests.