A new phototherapy regimen during winter as an add-on therapy, coupled with oral vitamin D supplementation, for the long-term control of atopic dermatitis study protocol for a multicentre, randomized, crossover, pragmatic trial - the PRADA trial

Autor: Droitcourt, Catherine, Barbarot, Sébastien, Maruani, Annabel, Darrieux, Laure, Misery, Laurent, Brenaut, Emilie, Adamski, Henri, Chabbert, Cécile, Vermersch, Annie, Weiborn, Marie, Seneschal, Julien, Taïeb, Alain, Plantin, Patrice, Maillard, Hervé, Phan, Alice, Skowron, François, Viguier, Manuelle, Staumont-Salle, Delphine, Nosbaum, Audrey, Soria, Angèle, Barbaud, Annick, Oger, Emmanuel, Dupuy, Alain
Přispěvatelé: Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Recherche en Pharmaco-épidémiologie et Recours aux Soins (REPERES), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-École des Hautes Études en Santé Publique [EHESP] (EHESP), CHU Pontchaillou [Rennes], Centre hospitalier universitaire de Nantes (CHU Nantes), CHU Trousseau [Tours], Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), French Ministry of Social Affairs and Health, France, Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Université de Rennes (UR)-École des Hautes Études en Santé Publique [EHESP] (EHESP), Centre Hospitalier Universitaire de Reims (CHU Reims), Immuno-Régulation dans les Maladies Auto-Immunes Inflammatoires et le Cancer - EA 7509 (IRMAIC), Université de Reims Champagne-Ardenne (URCA), Jonchère, Laurent
Jazyk: angličtina
Rok vydání: 2019
Předmět:
Zdroj: Trials
Trials, BioMed Central, 2019, 20 (1), pp.184. ⟨10.1186/s13063-019-3276-9⟩
Trials, 2019, 20 (1), pp.184. ⟨10.1186/s13063-019-3276-9⟩
Trials, BioMed Central, 2019, 20, ⟨10.1186/s13063-019-3276-9⟩
ISSN: 1745-6215
DOI: 10.1186/s13063-019-3276-9⟩
Popis: 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. Electronic supplementary material The online version of this article (10.1186/s13063-019-3276-9) contains supplementary material, which is available to authorized users.
Databáze: OpenAIRE
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