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
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
2 other identifiers
interventional
111
1 country
11
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2015
Longer than P75 for phase_2
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 28, 2015
CompletedFirst Posted
Study publicly available on registry
September 1, 2015
CompletedStudy Start
First participant enrolled
October 27, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 3, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 3, 2023
CompletedMarch 23, 2023
March 1, 2023
7.4 years
August 28, 2015
March 22, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Hierarchical criterion based on repeated measures of PO-SCORAD severity score
Measurement of PO-SCORAD score
2 years
Hierarchical criterion based on cumulative consumption of topical anti-inflammatory treatments (collected tubes) during winter
Measurement of cumulative consumption of topical anti-inflammatory treatments
2 years
Secondary Outcomes (10)
Assessment of desease severity
2 years
Assessment of desease severity
2 years
Assessment of desease severity
2 years
Assessment of desease severity
2 years
Assessment of the quality of life
2 years
- +5 more secondary outcomes
Study Arms (2)
Cholecalciferol
ACTIVE COMPARATORAdministration of cholecalciferol every 3 months during 2 years combined with new phototherapy regimen during winter (phototherapy winter 1, observation winter 2 or the opposite)
Placebo of cholecalciferol
PLACEBO COMPARATORAdministration 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)
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Hôpital Saint André
Bordeaux, 33075, France
Hôpital Morvan
Brest, 29609, France
Hôpital Trousseau
Chambray-lès-Tours, 37170, France
Centre Hospitalier
Le Mans, 72000, France
CHU de Nantes - Hôtel Dieu
Nantes, 44093, France
APHP - Hôpital Tenon
Paris, 75020, France
Centre Hospitalier
Périgueux, 24000, France
Hôpital Laënnec
Quimper, 29107, France
Hôpital Pontchaillou
Rennes, 35033, France
CHR St Brieuc
Saint-Brieuc, 22000, France
Centre Hospitalier
Valenciennes, 59322, France
Related Publications (1)
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.
PMID: 30909923DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Catherine Droitcourt
Rennes University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 28, 2015
First Posted
September 1, 2015
Study Start
October 27, 2015
Primary Completion
March 3, 2023
Study Completion
March 3, 2023
Last Updated
March 23, 2023
Record last verified: 2023-03