Logo of National Eczema Association mobile menu icon
Icon link to National Eczema's Instagram feed. Icon link to National Eczema's YouTube channel. Icon link to National Eczema's Facebook page. Icon link to National Eczema's Twitter feed. Icon link to National Eczema's inspire.com page. Search Icon to search the site

Get the tools and support you need to best manage your eczema

  • This field is for validation purposes and should be left unchanged.

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


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


Ages Eligible for Study

15 Years to N/A

Sexes Eligible for Study


Accepts Healthy Volunteers



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


Principal Investigator: Catherine Droitcourt

Rennes University Hospital

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



CHU d'Angers

Angers, 49100


Hôpital Saint André

Bordeaux, 33075


Hôpital Morvan

Brest, 29609


Hôpital Femme-Mère-Enfant - Hospices Civils de Lyon

Bron, 69500


Hôpital Trousseau

Chambray Les Tours, 37170


Emmanuelle Le Bidre


CHD Vendée

La Roche sur Yon, 85925


Centre Hospitalier

Le Mans, 72000


Corina Bara Passot


Hôpital Claude Huriez

Lille, 59037


CHU de Nantes - Hôtel Dieu

Nantes, 44093


APHP - Hôpital Tenon

Paris, 75020


Angèle Soria, MD


Centre Hospitalier

Perigueux, 24000


Hôpital Laënnec

Quimper, 29107


Hôpital Pontchaillou

Rennes, 35033


CHR St Brieuc

Saint Brieuc, 22000


Centre Hospitalier

Valence, 26000


Centre Hospitalier

Valenciennes, 59322