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Prolonging Time to Flare in Pediatric Atopic Dermatitis: A Randomized, Investigator-Blinded, Controlled, Multicenter Clinical Study of a Ceramide-Containing Moisturizer

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机构: [1]Capital Med Univ, Beijing Childrens Hosp, Natl Ctr Childrens Hlth, Beijing, Peoples R China; [2]Shenzhen Childrens Hosp, Dept Dermatol, Shenzhen, Guangdong, Peoples R China; [3]Hunan Childrens Hosp, Dept Dermatol, Changsha, Hunan, Peoples R China; [4]XinHua Hosp, Dept Dermatol, Shanghai, Peoples R China; [5]Galderma R&D, Sophia Antipolis, France
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关键词: Atopic dermatitis Ceramide Corticosteroid Flare prevention Moisturizer Patient satisfaction

摘要:
Introduction: Delaying or preventing flares is important in atopic dermatitis (AD) management. The objective of the study was to evaluate whether using a ceramide-containing moisturizer in addition to a body wash during latent AD can delay flares. Methods: This was a randomized, investigator-blinded, parallel-group, controlled study among Chinese children with a history of mild to moderate AD, within 1 week of successful treatment with a topical corticosteroid. Subjects were randomized to receive moisturizer twice daily and body wash once daily, or body wash alone once daily for 12 weeks. The primary efficacy endpoint was time to flare [necessitating medical therapy and/or Investigator Global Assessment (IGA) > 1 (at least mild AD)]. Other efficacy endpoints were AD characteristics and emollient effects. The patient-reported outcome comprised satisfaction at week 12. The safety endpoint was incidence of undesirable events. Results: A total of 64 subjects aged 2-12 years were randomized. Median time to flare was delayed by nearly 2 months for moisturizer/body wash compared to body wash alone (89 vs. 27 days, respectively). A significantly earlier onset of action in terms of fewer flares favoring moisturizer was found at week 4 (31 vs. 59%, respectively, p = 0.022), and after 12 weeks, fewer flares occurred (50 vs. 72%). At week 12 for flare-free subjects, nearly half in both groups had clear IGA, and an emollient effect in terms of less dryness or burning was more marked for moisturizer/body wash. Both products led to high patient satisfaction and were well tolerated. Conclusions: A regimen incorporating a moisturizer plus body wash delayed AD flares by nearly 2 months compared to body wash alone, and yielded high patient satisfaction.

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出版当年[2016]版:
大类 | 3 区 医学
小类 | 3 区 药学 4 区 医学:研究与实验
最新[2025]版:
大类 | 3 区 医学
小类 | 2 区 药学 3 区 医学:研究与实验
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出版当年[2015]版:
Q2 MEDICINE, RESEARCH & EXPERIMENTAL Q2 PHARMACOLOGY & PHARMACY
最新[2024]版:
Q1 PHARMACOLOGY & PHARMACY Q2 MEDICINE, RESEARCH & EXPERIMENTAL

影响因子: 最新[2024版] 最新五年平均 出版当年[2015版] 出版当年五年平均 出版前一年[2014版] 出版后一年[2016版]

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第一作者机构: [1]Capital Med Univ, Beijing Childrens Hosp, Natl Ctr Childrens Hlth, Beijing, Peoples R China;
通讯作者:
通讯机构: [1]Capital Med Univ, Beijing Childrens Hosp, Natl Ctr Childrens Hlth, Beijing, Peoples R China;
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