A new phototherapy regimen during winter as an add-on therapy, coupled with oral vitamin D supplementation, for the long-term control ... View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2019-03-25

AUTHORS

Catherine Droitcourt, Sébastien Barbarot, Annabel Maruani, Laure Darrieux, Laurent Misery, Emilie Brenaut, Henri Adamski, Cécile Chabbert, Annie Vermersch, Marie Weiborn, Julien Seneschal, Alain Taïeb, Patrice Plantin, Hervé Maillard, Alice Phan, François Skowron, Manuelle Viguier, Delphine Staumont-Salle, Audrey Nosbaum, Angèle Soria, Annick Barbaud, Emmanuel Oger, Alain Dupuy,

ABSTRACT

BACKGROUND: Atopic dermatitis is a highly prevalent, chronic, relapsing disease in both adults and children. On the severity spectrum, lower-end patients benefit from small amounts of topical anti-inflammatory treatments (TAT), whereas higher-end patients need systemic immunosuppressants; in-between patients are treated with TAT and phototherapy. The major therapeutic challenge in this population is the long-term control of disease activity, and the current TAT-based pro-active strategy does not meet all their needs. Immunosuppressants are used as long-term control add-on treatments, but they are restricted to the most severely affected patients because of safety concerns. In addition, neither immunosuppressants nor other strategies have been properly evaluated in the long term despite long-term control having been acknowledged as one of the most important core outcome domains to be targeted in atopic dermatitis trials. Safe add-on therapies, rigorously evaluated for long-term control of the disease, are therefore needed. Phototherapy and vitamin D supplementation are both good candidates. METHODS: This is a multicenter, national, randomized, superiority, crossover trial testing add-on phototherapy (one winter under spaced sessions of phototherapy and one winter under observation) among subjects receiving standard care (i.e., TAT). On the same population, we will test the long-term control provided by oral supplementation of vitamin D versus placebo in a randomized, superiority, double-blind, parallel-group trial. The primary outcomes are (1) repeat measures of the PO-SCORAD severity score over 1 year and (2) cumulate consumption of TAT (number of tubes) during the winter. They will be tested following a hierarchical testing procedure. The secondary outcomes will be measures repeated over 2 years of investigator-based severity scores, patient-reported severity and quality of life scores, serum vitamin D levels, weeks during which the disease is well-controlled, inter-visit cumulate consumption of TAT, and synthetic patient-reported satisfaction at the end of each winter. DISCUSSION: This study includes two separate 2-year pragmatic trials designed to evaluate the efficacy of vitamin D supplementation and pro-active phototherapy for primary care atopic dermatitis patients receiving TAT on long-term control of disease activity. The experimental design enables the study of both interventions and exploration of the interaction between vitamin D and phototherapy. A pragmatic trial is particularly suited to the assessment of long-term control. This study explores the possibility of new and safe therapeutic strategies for the control of long-term atopic dermatitis, and is an example of efficacy research that is unlikely to be sponsored by industrialists. A potentially effective low-cost therapeutic strategy for long-term control is essential for patients and public health. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02537509 , first received: 1 September 2015. More... »

PAGES

184

References to SciGraph publications

  • 2013-08-28. Willingness to pay and quality of life in patients with atopic dermatitis in ARCHIVES OF DERMATOLOGICAL RESEARCH
  • Journal

    TITLE

    Trials

    ISSUE

    1

    VOLUME

    20

    Author Affiliations

  • EA 7449 REPERES “Pharmaco-epidemiology and Health Services Research”, Univ Rennes, 35000 Rennes, France
  • Department of Dermatology, University Hospital Center of Nantes, 44000 Nantes, France
  • Department of Dermatology, University Hospital Center of Tours, 37000 Tours, France
  • Department of Dermatology, Hospital Center of Saint-Brieuc, 22000 Saint-Brieuc, France
  • Department of Dermatology, University Hospital Center of Brest, 29000 Brest, France
  • Department of Dermatology, University Hospital Center of Rennes, Pontchaillou Hospital, 2 rue Henri le Guilloux, 35000 Rennes, France
  • Department of Dermatology, Hospital Center of Perigueux, 24000 Perigueux, France
  • Department of Dermatology, Hospital Center of Valenciennes, 62000 Valenciennes, France
  • Department of Dermatology, University Hospital Center of Bordeaux, 33000 Bordeaux, France
  • Department of Dermatology, Hospital Center of Quimper, 29000 Quimper, France
  • Department of Dermatology, Hospital Center of Le Mans, 72000 Angers, France
  • Department of Dermatology, University Hospital Center of Lyon, 69000 Lyon-Bron, France
  • Department of Dermatology, Hospital Center of Valence, 26000 Valence, France
  • Department of Dermatology, University Hospital Center of Reims, 51000 Reims, France
  • Department of Dermatology, University Hospital Center of Lille, 59000 Lille, France
  • Department of Dermatology, University Hospital Center of Lyon, 69000 Lyon Sud, France
  • Department of Dermatology and Allergology, University Hospital Center of Paris-Tenon, 75020 Paris, France
  • Identifiers

    URI

    http://scigraph.springernature.com/pub.10.1186/s13063-019-3276-9

    DOI

    http://dx.doi.org/10.1186/s13063-019-3276-9

    DIMENSIONS

    https://app.dimensions.ai/details/publication/pub.1112981871

    PUBMED

    https://www.ncbi.nlm.nih.gov/pubmed/30909923


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