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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)

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Cholecalciferol
Placebo of cholecalciferol
Sponsored by
Rennes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hôpital Saint André
  • Hôpital Morvan
  • Hôpital Trousseau
  • Centre Hospitalier
  • CHU de Nantes - Hôtel Dieu
  • APHP - Hôpital Tenon
  • Centre Hospitalier
  • Hôpital Laënnec
  • Hôpital Pontchaillou
  • CHR St Brieuc
  • Centre Hospitalier

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Cholecalciferol

Placebo of cholecalciferol

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

Hierarchical criterion based on repeated measures of PO-SCORAD severity score
Measurement of PO-SCORAD score
Hierarchical criterion based on cumulative consumption of topical anti-inflammatory treatments (collected tubes) during winter
Measurement of cumulative consumption of topical anti-inflammatory treatments

Secondary Outcome Measures

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

Full Information

First Posted
August 28, 2015
Last Updated
March 22, 2023
Sponsor
Rennes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02537509
Brief Title
PRAgmatic Trial in Atopic Dermatitis Testing Long-term Control Effectiveness of New Phototherapy Regimen During Winter Coupled With Oral Vitamin D Supplementation vs. Placebo
Acronym
PRADA
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
October 27, 2015 (Actual)
Primary Completion Date
March 3, 2023 (Actual)
Study Completion Date
March 3, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
111 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cholecalciferol
Arm Type
Active Comparator
Arm Description
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)
Arm Title
Placebo of cholecalciferol
Arm Type
Placebo Comparator
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
Cholecalciferol
Other Intervention Name(s)
Uvedose
Intervention Type
Drug
Intervention Name(s)
Placebo of cholecalciferol
Other Intervention Name(s)
Placebo of Uvedose
Primary Outcome Measure Information:
Title
Hierarchical criterion based on repeated measures of PO-SCORAD severity score
Description
Measurement of PO-SCORAD score
Time Frame
2 years
Title
Hierarchical criterion based on cumulative consumption of topical anti-inflammatory treatments (collected tubes) during winter
Description
Measurement of cumulative consumption of topical anti-inflammatory treatments
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Assessment of desease severity
Description
Assessment of desease severity by EASI score
Time Frame
2 years
Title
Assessment of desease severity
Description
Assessment of desease severity by IGA score
Time Frame
2 years
Title
Assessment of desease severity
Description
Assessment of desease severity by SCORAD score
Time Frame
2 years
Title
Assessment of desease severity
Description
Assessment of desease severity by POEM score
Time Frame
2 years
Title
Assessment of the quality of life
Description
Assessment of the quality of life by DLQI score
Time Frame
2 years
Title
Measurement of serum Vitamin D (25-(OH)-vitamin D)
Time Frame
2 years
Title
Measurement of total IgE serum
Time Frame
2 years
Title
Assessement of number of weeks of well-controlled atopic dermatitis
Time Frame
2 years
Title
Assessment of inter-visit cumulative consumption of topical anti-inflammatory treatments
Time Frame
2 years
Title
Assessment of patient satisfaction
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine Droitcourt
Organizational Affiliation
Rennes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Saint André
City
Bordeaux
ZIP/Postal Code
33075
Country
France
Facility Name
Hôpital Morvan
City
Brest
ZIP/Postal Code
29609
Country
France
Facility Name
Hôpital Trousseau
City
Chambray Les Tours
ZIP/Postal Code
37170
Country
France
Facility Name
Centre Hospitalier
City
Le Mans
ZIP/Postal Code
72000
Country
France
Facility Name
CHU de Nantes - Hôtel Dieu
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
APHP - Hôpital Tenon
City
Paris
ZIP/Postal Code
75020
Country
France
Facility Name
Centre Hospitalier
City
Perigueux
ZIP/Postal Code
24000
Country
France
Facility Name
Hôpital Laënnec
City
Quimper
ZIP/Postal Code
29107
Country
France
Facility Name
Hôpital Pontchaillou
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
CHR St Brieuc
City
Saint Brieuc
ZIP/Postal Code
22000
Country
France
Facility Name
Centre Hospitalier
City
Valenciennes
ZIP/Postal Code
59322
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
30909923
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.
Results Reference
derived

Learn more about this trial

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

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