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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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Abstract

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.

Conclusion

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.

Funding

Galderma R&D.

Trial Registration

ClinicalTrials.gov identifier, NCT02589392.

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Acknowledgements

Financial support was provided by Galderma R&D for the conduct of this study (all investigators received a research Grant), and for editorial assistance in manuscript writing. Article processing charges were funded by Galderma R&D. All authors had full access to all of the data in this study and take complete responsibility for the integrity of the data and accuracy of the data analysis. All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this manuscript, take responsibility for the integrity of the work as a whole, and have given final approval for the version to be published. The authors would like to thank Galadriel Bonnel, PhD, independent owner of Resonance Medical Writing & Consulting, and Helen Simpson, PhD, of Galderma R&D for editorial assistance.

Disclosures

Lin Ma was a principal investigator and contributed equally to the manuscript. Ping Li was a principal investigator and contributed equally to the manuscript. Jianping Tang was a principal investigator and contributed equally to the manuscript. Nabil Kerrouche is a full-time employee of Galderma R&D. Yifeng Guo, Chunping Shen and Jing Chang have nothing to disclose.

Compliance with Ethics Guidelines

All procedures performed were in accordance with the ethical standards of the institutional research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards, and in compliance with good clinical practices and local regulatory requirements. Informed consent was obtained from all individual participants included in the study.

Data Availability

The datasets generated during and/or analyzed during the current study are not publicly available as it is proprietary data, but all of the conclusions drawn in the manuscript are based on data included in the publication and supported by previous publications.

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Correspondence to Lin Ma.

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Ma, L., Li, P., Tang, J. et al. Prolonging Time to Flare in Pediatric Atopic Dermatitis: A Randomized, Investigator-Blinded, Controlled, Multicenter Clinical Study of a Ceramide-Containing Moisturizer. Adv Ther 34, 2601–2611 (2017). https://doi.org/10.1007/s12325-017-0640-6

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