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

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

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: Cholecalciferol; Drug: Placebo of cholecalciferol

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.

• Study Type: Interventional
• Enrollment (Actual): 111
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33075
    • Hôpital Saint André
  • Brest, France, 29609
    • Hôpital Morvan
  • Chambray Les Tours, France, 37170
    • Hôpital Trousseau
  • Le Mans, France, 72000
    • Centre Hospitalier
  • Nantes, France, 44093
    • CHU de Nantes - Hôtel Dieu
  • Paris, France, 75020
    • APHP - Hôpital Tenon
  • Perigueux, France, 24000
    • Centre Hospitalier
  • Quimper, France, 29107
    • Hôpital Laënnec
  • Rennes, France, 35033
    • Hôpital Pontchaillou
  • Saint Brieuc, France, 22000
    • CHR St Brieuc
  • Valenciennes, France, 59322
    • Centre Hospitalier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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)	Drug: Cholecalciferol; Other Names: Uvedose
Placebo Comparator: 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)	Drug: Placebo of cholecalciferol; Other Names: Placebo of Uvedose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of desease severity	Assessment of desease severity by EASI score	2 years
Assessment of desease severity	Assessment of desease severity by IGA score	2 years
Assessment of desease severity	Assessment of desease severity by SCORAD score	2 years
Assessment of desease severity	Assessment of desease severity by POEM score	2 years
Assessment of the quality of life	Assessment of the quality of life by DLQI score	2 years
Measurement of serum Vitamin D (25-(OH)-vitamin D)		2 years
Measurement of total IgE serum		2 years
Assessement of number of weeks of well-controlled atopic dermatitis		2 years
Assessment of inter-visit cumulative consumption of topical anti-inflammatory treatments		2 years
Assessment of patient satisfaction		2 years

Collaborators and Investigators

• Sponsor: Rennes University Hospital
• Investigators: Principal Investigator: Catherine Droitcourt, Rennes University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2015
• Primary Completion (Actual): March 3, 2023
• Study Completion (Actual): March 3, 2023

Study Registration Dates

• First Submitted: August 28, 2015
• First Submitted That Met QC Criteria: August 31, 2015
• First Posted (Estimate): September 1, 2015

Study Record Updates

• Last Update Posted (Actual): March 23, 2023
• Last Update Submitted That Met QC Criteria: March 22, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol
• Other Study ID Numbers: 2015-000881-73; 35RC14_9754_PRADA (Other Identifier: CHU de Rennes)