Clinical trial NCT02537509: PRAgmatic Trial in Atopic Dermatitis Testing Long-term Control Effectiveness of New Phototherapy Regimen During Winter Coupled With Oral Vitamin D Supplementation vs. Placebo
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2015-09-01
Enrollment: 111
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility 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.

Primary outcomes:
measure: Hierarchical criterion based on repeated measures of PO-SCORAD severity score
timeFrame: 2 years
measure: Hierarchical criterion based on cumulative consumption of topical anti-inflammatory treatments (collected tubes) during winter
timeFrame: 2 years
Secondary outcomes:
measure: Assessment of desease severity
timeFrame: 2 years
measure: Assessment of desease severity
timeFrame: 2 years
measure: Assessment of desease severity
timeFrame: 2 years
measure: Assessment of desease severity
timeFrame: 2 years
measure: Assessment of the quality of life
timeFrame: 2 years
measure: Measurement of serum Vitamin D (25-(OH)-vitamin D)
timeFrame: 2 years
measure: Measurement of total IgE serum
timeFrame: 2 years
measure: Assessement of number of weeks of well-controlled atopic dermatitis
timeFrame: 2 years
measure: Assessment of inter-visit cumulative consumption of topical anti-inflammatory treatments
timeFrame: 2 years
measure: Assessment of patient satisfaction
timeFrame: 2 years
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Hôpital Saint André
city: Brest
country: France
facility: Hôpital Morvan
city: Chambray Les Tours
country: France
facility: Hôpital Trousseau
city: Le Mans
country: France
facility: Centre Hospitalier
city: Nantes
country: France
facility: CHU de Nantes - Hôtel Dieu
city: Paris
country: France
facility: APHP - Hôpital Tenon
city: Perigueux
country: France
facility: Centre Hospitalier
city: Quimper
country: France
facility: Hôpital Laënnec
city: Rennes
country: France
facility: Hôpital Pontchaillou
city: Saint Brieuc
country: France
facility: CHR St Brieuc
city: Valenciennes
country: France
facility: Centre Hospitalier
Study officials:
affiliation: Rennes University Hospital
name: Catherine Droitcourt
role: PRINCIPAL_INVESTIGATOR
References:
citation: Droitcourt C, Barbarot S, Maruani A, Darrieux L, Misery L, Brenaut E, Adamski H, Chabbert C, Vermersch A, Weiborn M, Seneschal J, Taieb A, Plantin P, Maillard H, Phan A, Skowron F, Viguier M, Staumont-Salle D, Nosbaum A, Soria A, Barbaud A, Oger E, Dupuy A; Groupe de Recherche sur l'Eczema Atopique de la Societe Francaise de Dermatologie (GREAT). 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. Trials. 2019 Mar 25;20(1):184. doi: 10.1186/s13063-019-3276-9.