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

Sponsor

Rennes University Hospital (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02537509

Collaborator

(none)

111

Enrollment

Locations

Arms

85.2

Anticipated Duration (Months)

10.1

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Atopic Dermatitis	Drug: Cholecalciferol Drug: Placebo of cholecalciferol	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

111 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Oct 27, 2015

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Hierarchical criterion based on repeated measures of PO-SCORAD severity score [2 years]
Measurement of PO-SCORAD score
Hierarchical criterion based on cumulative consumption of topical anti-inflammatory treatments (collected tubes) during winter [2 years]
Measurement of cumulative consumption of topical anti-inflammatory treatments

Secondary Outcome Measures

Assessment of desease severity [2 years]
Assessment of desease severity by EASI score
Assessment of desease severity [2 years]
Assessment of desease severity by IGA score
Assessment of desease severity [2 years]
Assessment of desease severity by SCORAD score
Assessment of desease severity [2 years]
Assessment of desease severity by POEM score
Assessment of the quality of life [2 years]
Assessment of the quality of life by DLQI score
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Hôpital Saint André	Bordeaux	France	33075
2	Hôpital Morvan	Brest	France	29609
3	Hôpital Trousseau	Chambray Les Tours	France	37170
4	Centre Hospitalier	Le Mans	France	72000
5	CHU de Nantes - Hôtel Dieu	Nantes	France	44093
6	APHP - Hôpital Tenon	Paris	France	75020
7	Centre Hospitalier	Perigueux	France	24000
8	Hôpital Laënnec	Quimper	France	29107
9	Hôpital Pontchaillou	Rennes	France	35033
10	CHR St Brieuc	Saint Brieuc	France	22000
11	Centre Hospitalier	Valenciennes	France	59322