Skip to main content
SpringerLink
Log in

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

  • Original Research
  • Published:
Advances in Therapy Aims and scope Submit manuscript

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.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2
Fig. 3

Similar content being viewed by others

References

  1. Watson W, Kapur S. Atopic dermatitis. Allergy Asthma Clin Immunol 2011;7 (Suppl 1):S4. no. 2011.

  2. Krakowski AC, Eichenfield LF, Dohil MA. Management of atopic dermatitis in the pediatric population. Pediatrics. 2008;122:812–24.

    Article  PubMed  Google Scholar 

  3. Deckers IA, McLean S, Linssen S, et al. Investigating international time trends in the incidence and prevalence of atopic eczema 1990–2010: a systematic review of epidemiological studies. PLoS ONE. 2012;7(7):e39803.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  4. Wang X, Li LF, Zhao DY, et al. Prevalence and clinical features of atopic dermatitis in China. Biomed Res Int. 2016;2016:2568301.

    PubMed  PubMed Central  Google Scholar 

  5. Xu F, Yan S, Li F, Cai M, Chai W, Wu M, Fu C, Zhao Z, Kan H, Kang K, Xu J. Prevalence of childhood atopic dermatitis: an urban and rural community-based study in Shanghai, China. PLoS ONE. 2012;7:e36174.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  6. Zhao J, Bai J, Shen KL, et al. Questionnaire-based survey of allergic diseases among children aged 0–14 years in the downtown of Beijing, Chongqing and Guangzhou. Zhonghua Er Ke Za Zhi. 2011;49(10):740–4.

    PubMed  Google Scholar 

  7. Catherine Mack Correa M, Nebus J. Management of patients with atopic dermatitis: the role of emollient therapy. Dermatol Res Pract 2012;2012:836931.

    CAS  PubMed  PubMed Central  Google Scholar 

  8. Ring J, Alomar A, Bieber T, et al. Guidelines for treatment of atopic eczema (atopic dermatitis) part I. J Eur Acad Dermatol Venereol. 2012;26:1045–60.

    Article  CAS  PubMed  Google Scholar 

  9. Simpson E, Dutronc Y. A new body moisturizer increases skin hydration and improves atopic dermatitis symptoms among children and adults. J Drugs Dermatol. 2011;10:744–9.

    PubMed  Google Scholar 

  10. Simpson E, Böhling A, Bielfeldt S, et al. Improvement of skin barrier function in atopic dermatitis patients with a new moisturizer containing a ceramide precursor. J Dermatol Treat. 2013;24:122–5.

    Article  CAS  Google Scholar 

  11. Barbier N, Paul C, Luger T, et al. Validation of the Eczema Area and Severity Index for atopic dermatitis in a cohort of 1550 patients from the pimecrolimus cream 1% randomized controlled clinical trials programme. Br J Dermatol. 2004;150:96–102.

    Article  CAS  PubMed  Google Scholar 

  12. Schmitt J, Spuls PI, Thomas KS, et al. The Harmonising Outcome Measures for Eczema (HOME) statement to assess clinical signs of atopic eczema in trials. J Allergy Clin Immunol. 2014;134(4):800–7.

    Article  PubMed  Google Scholar 

  13. Wirén K, Nohlgard C, Nyberg F, et al. Treatment with a barrier-strengthening moisturizing cream delays relapse of atopic dermatitis: a prospective and randomized controlled clinical trial. J Eur Acad Dermatol Venereol. 2009;23:1267–72.

    Article  PubMed  Google Scholar 

  14. Gu SX, Zhang AL, Coyle ME, et al. Chinese herbal medicine granules (PTQX) for children with moderate to severe atopic eczema: study protocol for a randomised controlled trial. Trials. 2015;16:294.

    Article  PubMed  PubMed Central  Google Scholar 

  15. Del Rosso JQ, Kircik LH. The integration of physiologically-targeted skin care in the management of atopic dermatitis: focus on the use of a cleanser and moisturizer system incorporating a ceramide precursor, filaggrin degradation products, and specific “skin-barrier-friendly” excipients. J Drugs Dermatol. 2013;12(7suppl):s85–91.

    Google Scholar 

  16. Eichenfield LF, Tom WL, Berger TG, et al. Guidelines of care for the management of atopic dermatitis: section 2. Management and treatment of atopic dermatitis with topical therapies. J Am Acad Dermatol. 2014;71(1):116–32.

    Article  PubMed  PubMed Central  Google Scholar 

  17. Simpson E, Trookman NS, Ronald LR, et al. Safety and tolerability of a body wash and moisturizer when applied to infants and toddlers with a history of atopic dermatitis: results from an Open-Label Study. Pediatric Dermatol. 2012;29:590–7.

    Article  Google Scholar 

  18. van Zuuren EJ, Fedorowicz Z, Christensen R, Lavrijsen A, Arents BWM. Emollients and moisturisers for eczema. Cochrane Database Syst Rev 2017;2:CD012119. https://doi.org/10.1002/14651858.CD012119.pub2.

    PubMed  Google Scholar 

  19. van Zuuren EJ, Fedorowicz Z, Arents BWM. Performance and tolerability of the moisturizers Cetaphil® and Excipialin® in Atopic Dermatitis: What is the evidence based on randomized trials? Dermatol Ther 2017 ([Epub ahead of print]).

  20. Weber TM, Samarin F, Babcock MJ, et al. steroid-free over-the-counter eczema skin care formulations reduce risk of flare, prolong time to flare, and reduce eczema symptoms in pediatric subjects with atopic dermatitis. J Drugs Dermatol. 2015;14(5):478–85.

    CAS  PubMed  Google Scholar 

  21. Sidbury R, Tom WL, Bergman JN, et al. Guidelines of care for the management of atopic dermatitis: section 4. Prevention of disease flares and use of adjunctive therapies and approaches. J Am Acad Dermatol. 2014;71(6):1218–33.

    Article  PubMed  PubMed Central  Google Scholar 

  22. Rubel D, Thirumoorthy T, Soebaryo RW, et al. Asia-Pacific Consensus Group for Atopic Dermatitis. Consensus guidelines for the management of atopic dermatitis: an Asia-Pacific perspective. J Dermatol. 2013;40:160–71.

    Article  CAS  PubMed  Google Scholar 

  23. Tollefson MM, Bruckner AL. Atopic dermatitis: skin-directed management. Pediatrics. 2014;134(6):e1735–44.

    Article  PubMed  Google Scholar 

Download references

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.

Author information

Authors and Affiliations

  1. Beijing Children’s Hospital, Capital Medical University, National Center for Children’s Health, Beijing, China

    Lin Ma & Chunping Shen

  2. Department of Dermatology, Shenzhen Children’s Hospital, Shenzhen, Guangdong Province, China

    Ping Li

  3. Department of Dermatology, Hunan Children’s Hospital, Hunan, China

    Jianping Tang & Jing Chang

  4. Department of Dermatology, XinHua Hospital, Shanghai, China

    Yifeng Guo

  5. Galderma R&D, Sophia Antipolis, France

    Nabil Kerrouche

Authors
  1. Lin Ma
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Ping Li
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Jianping Tang
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Yifeng Guo
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Chunping Shen
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Jing Chang
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Nabil Kerrouche
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Lin Ma.

Additional information

Enhanced Content

To view enhanced content for this article go to http://www.medengine.com/Redeem/EDCCF06051B7FC7F.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

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

Download citation

  • Received:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s12325-017-0640-6

Keywords

Search

Navigation