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

NCT ID: NCT02537509

Last Updated: 2023-03-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 111 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-27
• Study Completion Date: 2023-03-03

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.

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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)

Group Type: ACTIVE_COMPARATOR

Cholecalciferol

Intervention Type: DRUG

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)

Group Type: PLACEBO_COMPARATOR

Placebo of cholecalciferol

Intervention Type: DRUG

Interventions

Cholecalciferol

Intervention Type: DRUG

Placebo of cholecalciferol

Intervention Type: DRUG

Other Intervention Names

Uvedose; Placebo of Uvedose

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.

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rennes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Catherine Droitcourt

Role: PRINCIPAL_INVESTIGATOR

Rennes University Hospital

Locations

Hôpital Saint André

Bordeaux, , France

Hôpital Morvan

Brest, , France

Hôpital Trousseau

Chambray-lès-Tours, , France

Centre Hospitalier

Le Mans, , France

CHU de Nantes - Hôtel Dieu

Nantes, , France

APHP - Hôpital Tenon

Paris, , France

Centre Hospitalier

Périgueux, , France

Hôpital Laënnec

Quimper, , France

Hôpital Pontchaillou

Rennes, , France

CHR St Brieuc

Saint-Brieuc, , France

Centre Hospitalier

Valenciennes, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 30909923 (View on PubMed)

Other Identifiers

35RC14_9754_PRADA

Identifier Type: OTHER

Identifier Source: secondary_id

2015-000881-73

Identifier Type: -

Identifier Source: org_study_id