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PRAgmatic Trial in Atopic Dermatitis Testing Long-term Control Effectiveness of New Phototherapy Regimen During Winter Coupled With Oral Vitamin D Supplementation vs. Placebo (PRADA)

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ClinicalTrials.gov Identifier: NCT02537509
Recruitment Status : Recruiting
First Posted : September 1, 2015
Last Update Posted : August 9, 2018
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital

Brief Summary:
Spaced phototherapy sessions during winter as add-on therapy in combination with vitamin D supplementation or not, could be beneficial to improve disease LTC in AD patients

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: Cholecalciferol Drug: Placebo of cholecalciferol Phase 2

Detailed Description:

The major therapeutic challenge in patient with Atopic Dermatitis is long-term control of disease activity (LTC), for which the current TAT-based pro-active strategy does not meet all the needs.

Phototherapy is a good candidate: it is widely used as a second-line treatment in AD with demonstrated efficacy. However, only short-term control has been evaluated; and only 2-3 times a week intensive schedules have been tested and are used in current practice. A novel phototherapy regimen would be required for disease LTC, allowing a trade-off between disease control, UV-induced risks, and patient adherence.

Vitamin D supplementation is another good candidate: several studies have shown lower serum levels of vitamin D to be correlated with more severe AD; and three short-term, low-power low-quality, placebo-controlled randomised trials testing vitamin D supplementation yielded conflicting results, leaving its therapeutic efficacy undecided for short-term control, and unknown for LTC.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Multicentre, Cross-over, PRAgmatic Trial in Atopic Dermatitis Testing Long-term Control Effectiveness of New Phototherapy Regimen During Winter as an add-on Therapy, Coupled With Oral Vitamin D Supplementation vs. Placebo in a Randomised, Parallel-group Trial
Actual Study Start Date : October 27, 2015
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema Vitamin D

Arm Intervention/treatment
Active Comparator: Cholecalciferol
Administration of cholecalciferol every 3 months during 2 years combined with new phototherapy regimen during winter (phototherapy winter 1, observation winter 2 or the opposite)
Drug: Cholecalciferol
Other Name: Uvedose

Placebo Comparator: Placebo of cholecalciferol
Administration of placebo of cholecalciferol every 3 months during 2 years combined with new phototherapy regimen during winter (phototherapy winter 1, observation winter 2 or the opposite)
Drug: Placebo of cholecalciferol
Other Name: Placebo of Uvedose




Primary Outcome Measures :
  1. Hierarchical criterion based on repeated measures of PO-SCORAD severity score [ Time Frame: 2 years ]
    Measurement of PO-SCORAD score

  2. Hierarchical criterion based on cumulative consumption of topical anti-inflammatory treatments (collected tubes) during winter [ Time Frame: 2 years ]
    Measurement of cumulative consumption of topical anti-inflammatory treatments


Secondary Outcome Measures :
  1. Assessment of desease severity [ Time Frame: 2 years ]
    Assessment of desease severity by EASI score

  2. Assessment of desease severity [ Time Frame: 2 years ]
    Assessment of desease severity by IGA score

  3. Assessment of desease severity [ Time Frame: 2 years ]
    Assessment of desease severity by SCORAD score

  4. Assessment of desease severity [ Time Frame: 2 years ]
    Assessment of desease severity by POEM score

  5. Assessment of the quality of life [ Time Frame: 2 years ]
    Assessment of the quality of life by DLQI score

  6. Measurement of serum Vitamin D (25-(OH)-vitamin D) [ Time Frame: 2 years ]
  7. Measurement of total IgE serum [ Time Frame: 2 years ]
  8. Assessement of number of weeks of well-controlled atopic dermatitis [ Time Frame: 2 years ]
  9. Assessment of inter-visit cumulative consumption of topical anti-inflammatory treatments [ Time Frame: 2 years ]
  10. Assessment of patient satisfaction [ Time Frame: 2 years ]


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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with atopic dermatitis (Hanifin and Rajka criteria),
  • Aged 15 years or more,
  • With > 2 years of disease evolution,
  • With moderate-to-severe disease (IGA > 2),
  • Patients that have received TAT for at least 12 weeks and have symptoms requiring an increase in therapy,
  • Seasonality in disease severity (based on a questionnaire assessing disease improvement during summer),
  • Easy access to a phototherapy cabin (widely implanted in primary care dermatology private practice in France),
  • Effective contraception to be used at least 30 days before initiation of treatment, during treatment and 29 weeks after last administration for women of reproductive age,
  • Written informed consent of the patient
  • For patients aged between 15 and 18, written informed consent of the parents and of the teenager.

Exclusion Criteria:

  • Any cause of contra-indication for vitamin D supplementation: flare of granulomatosis, primary hyperparathyroidism,
  • Clinical suspicion of hypercalciuria,
  • Indication to a systemic immunosuppressant in the next 2 years,
  • Atopic dermatitis known to be aggravated by UV exposure,
  • Any contra-indication for artificial or solar exposure including: genetic diseases with a predisposition to skin cancer, any history of personal skin cancer (melanoma, squamous cell skin cancer, basal cell skin cancer), lupus, dermatomyositis, any other photosensitizing skin disease, photosensitizing medication (see appendix 2),
  • More than 100 previous phototherapy sessions in lifetime,
  • Pregnancy or breastfeeding,
  • Persons subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02537509


Contacts
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Contact: Catherine Droitcourt +33 2 99 28 43 49 catherine.droitcourt@chu-rennes.fr

Locations
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France
CHU d'Angers Withdrawn
Angers, France, 49100
Hôpital Saint André Recruiting
Bordeaux, France, 33075
Contact: Julien Seneschal    +33 5 56 79 49 62    julien.seneschal@chu-bordeaux.fr   
Hôpital Morvan Recruiting
Brest, France, 29609
Contact: Claire Abasq       claire.abasq@chu-brest.fr   
Hôpital Femme-Mère-Enfant - Hospices Civils de Lyon Withdrawn
Bron, France, 69500
Hôpital Trousseau Recruiting
Chambray Les Tours, France, 37170
Contact: Emmanuelle Le Bidre    +33 2 47 47 47 47 (7-1985)    emmanuelle_lb@yahoo.fr   
CHD Vendée Withdrawn
La Roche sur Yon, France, 85925
Centre Hospitalier Recruiting
Le Mans, France, 72000
Contact: Corina Bara Passot    +33 2 44 71 07 50    cbara@ch-lemans.fr   
Hôpital Claude Huriez Not yet recruiting
Lille, France, 59037
Contact: Delphine Staumont-Sallé    +33 3 20 44 41 93    delphine.salle@chru-lille.fr   
CHU de Nantes - Hôtel Dieu Recruiting
Nantes, France, 44093
Contact: Sébastien Barbarot    +33 2 40 08 40 86    sebastien.barbarot@chu-nantes.fr   
APHP - Hôpital Tenon Not yet recruiting
Paris, France, 75020
Contact: Angèle Soria, MD    01 56 01 72 20    angele.soria@aphp.fr   
Centre Hospitalier Recruiting
Perigueux, France, 24000
Contact: Cécile Javierre-Chabbert       cchabbert@hotmail.fr   
Hôpital Laënnec Not yet recruiting
Quimper, France, 29107
Contact: Patrice Plantin    +33 2 90 94 41 16    p.plantin@ch-cornouaille.fr   
Hôpital Pontchaillou Recruiting
Rennes, France, 35033
Contact: Catherine Droitcourt    +33 2 99 28 43 49    catherine.droitcourt@chu-rennes.fr   
Sub-Investigator: Alain Dupuy         
Sub-Investigator: Henri Adamski         
CHR St Brieuc Recruiting
Saint Brieuc, France, 22000
Contact: Laure Darrieux    +33 2 96 01 74 66    laure.darrieux@ch-stbrieuc.fr   
Centre Hospitalier Withdrawn
Valence, France, 26000
Centre Hospitalier Recruiting
Valenciennes, France, 59322
Contact: Marie Weinborn    +33 3 27 17 50 58    weinborn-m@ch-valenciennes.fr   
Sponsors and Collaborators
Rennes University Hospital
Investigators
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Principal Investigator: Catherine Droitcourt Rennes University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT02537509     History of Changes
Other Study ID Numbers: 2015-000881-73
35RC14_9754_PRADA ( Other Identifier: CHU de Rennes )
First Posted: September 1, 2015    Key Record Dates
Last Update Posted: August 9, 2018
Last Verified: September 2017

Additional relevant MeSH terms:
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Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Vitamin D
Cholecalciferol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents