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


Rennes University Hospital
NCT ID: NCT02537509
Last Updated: June 20, 2019

The Study at a Glance

  • Status: Recruiting
  • Phase: Phase 2
  • Gender: All
  • Age: 15 Years - N/A
  • Condition: Atopic Dermatitis
  • Study Type: Interventional
  • Intervention:
  • Lead Sponsor: Rennes University Hospital
  • Location: Not Provided

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

Purpose

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

Eligibility

Ages Eligible for Study

15 Years to N/A

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.

Additional Information, Locations & Contacts

Sponsors & Collaborators

Rennes University Hospital

Investigators

Principal Investigator: Catherine Droitcourt

Rennes University Hospital

Please refer to this study by its ClinicalTrials.gov identifier: NCT02537509

Location

Contacts

CHU d'Angers

Angers, 49100

France

Hôpital Saint André

Bordeaux, 33075

France

Hôpital Morvan

Brest, 29609

France

Hôpital Femme-Mère-Enfant - Hospices Civils de Lyon

Bron, 69500

France

Hôpital Trousseau

Chambray Les Tours, 37170

France

Emmanuelle Le Bidre

emmanuelle_lb@yahoo.fr

CHD Vendée

La Roche sur Yon, 85925

France

Centre Hospitalier

Le Mans, 72000

France

Corina Bara Passot

cbara@ch-lemans.fr

Hôpital Claude Huriez

Lille, 59037

France

CHU de Nantes - Hôtel Dieu

Nantes, 44093

France

APHP - Hôpital Tenon

Paris, 75020

France

Angèle Soria, MD

angele.soria@aphp.fr

Centre Hospitalier

Perigueux, 24000

France

Hôpital Laënnec

Quimper, 29107

France

Hôpital Pontchaillou

Rennes, 35033

France

CHR St Brieuc

Saint Brieuc, 22000

France

Centre Hospitalier

Valence, 26000

France

Centre Hospitalier

Valenciennes, 59322

France