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CompletedNCT02537509PRADAUpdated Mar 23, 2023

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

A Phase 2 interventional study of Cholecalciferol and Placebo of cholecalciferol in Atopic Dermatitis, sponsored by Rennes University Hospital. Completed at 11 sites in France. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2023-03-23.

Sponsored by Rennes University Hospital · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
111
Allocation
Randomized
Ages
15 Years and older
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Atopic Dermatitis
03

In context

Dermatitis, Atopic

1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.

This study's enrollment of 111 is above the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.

Browse Dermatitis, Atopic studies →

Lead sponsor

Rennes University Hospital is the lead sponsor of 440 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
111 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • DrugCholecalciferol

    Also known as: Uvedose

  • DrugPlacebo of cholecalciferol

    Also known as: Placebo of Uvedose

06

What researchers measure

Primary outcomes

  1. Hierarchical criterion based on repeated measures of PO-SCORAD severity score

    Measurement of PO-SCORAD score

    Time frame: 2 years

  2. Hierarchical criterion based on cumulative consumption of topical anti-inflammatory treatments (collected tubes) during winter

    Measurement of cumulative consumption of topical anti-inflammatory treatments

    Time frame: 2 years

Secondary outcomes

  1. Assessment of desease severity

    Assessment of desease severity by EASI score

    Time frame: 2 years

  2. Assessment of desease severity

    Assessment of desease severity by IGA score

    Time frame: 2 years

  3. Assessment of desease severity

    Assessment of desease severity by SCORAD score

    Time frame: 2 years

  4. Assessment of desease severity

    Assessment of desease severity by POEM score

    Time frame: 2 years

  5. Assessment of the quality of life

    Assessment of the quality of life by DLQI score

    Time frame: 2 years

  6. Measurement of serum Vitamin D (25-(OH)-vitamin D)

    Time frame: 2 years

  7. Measurement of total IgE serum

    Time frame: 2 years

  8. Assessement of number of weeks of well-controlled atopic dermatitis

    Time frame: 2 years

  9. Assessment of inter-visit cumulative consumption of topical anti-inflammatory treatments

    Time frame: 2 years

  10. Assessment of patient satisfaction

    Time frame: 2 years

07

Study locations

11 sites
  • Hôpital Saint André
    Bordeaux, 33075, France
  • Hôpital Morvan
    Brest, 29609, France
  • Hôpital Trousseau
    Chambray Les 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
    Perigueux, 24000, France
  • Hôpital Laënnec
    Quimper, 29107, France
  • Hôpital Pontchaillou
    Rennes, 35033, France
  • CHR St Brieuc
    Saint Brieuc, 22000, France
  • Centre Hospitalier
    Valenciennes, 59322, France
08

References and documents

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. PubMed 30909923 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 23, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02537509
Lead sponsor
Rennes University Hospital
Responsible party
Sponsor
First posted
Sep 1, 2015
Start date
Oct 27, 2015
Primary completion
Mar 3, 2023
Completion
Mar 3, 2023
Last update
Mar 23, 2023

Study contacts

Catherine Droitcourt
principal investigator · Rennes University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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