The purpose of this study was to determine the efficacy and the tolerability of the Charme™ system, a hand-held device that electrolyzes a water-based sodium chloride solution and delivers electrolyzed oxidized water (EOW) to the skin, in the treatment of mild to moderate acne. A total of 31 patients with mild to moderate acne vulgaris were enrolled in this 8-week, open-label, split-face pilot study. Acne lesion counts and physician global assessments were taken at each visit, as well as patient satisfaction and global assessments and high-resolution digital photographs. Statistical analysis of the. results for treatment versus baseline scores was performed using a Hotelling T test and repeated-measures analysis of variance. Values of .04 or less were considered statistically significant. A total of 25 patients (mean age, 24.7 years, ranging from 15 to 47 years) completed the study. The mean reduction in total acne lesion counts from baseline to the end of treatment was 40.9% for the EOW-treated side (right side) and 18% for the untreated side (left side) (P=.04). Investigators observed a significant mean reduction in inflammatory lesions, both papules and pustules (P<.01), as well as in the number of individual papules (75.7% vs 19.4%) and pustules (42% vs 7.38%) on the treated side versus the untreated side (P=.02). The mean reduction of the noninflammatory lesions, however, was not significant (P=.336). Physician global assessment indicated that 100% of the patients showed clinical improvement of 25% or more, while 50% of the patients observed a moderate improvement of 50% or more at the end of the treatment period. Interestingly, 75% of the patients preferred the EOW delivery system to other conventional treatment modalities. Only 5 patients had transient, cutaneous adverse effects, such as pruritus, erythema, burning/stinging, and/or peeling, that ceased by week 2. Patient satisfaction with the EOW system was rated high, with 80% of the patients in the study assessing the EOW device as good or excellent, while 16% rated the device as fair. Only 4% of the patients were dissatisfied with the device. The pilot study demonstrated that the EOW system is an effective and well-tolerated method of treatment for patients with acne. The device appeared to be effective primarily on inflammatory acne lesions. This is most likely attributed to the antimicrobial properties of the EOW that reduce the Propionibacterium acnes populations.
|Original language||English (US)|
|Number of pages||13|
|State||Published - Feb 1 2004|
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