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

Atopic Dermatitis Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02537509
• Other study ID #: 2015-000881-73
• Secondary ID: 35RC14_9754_PRAD
• Status: Completed
• Phase: Phase 2
• Start date: October 27, 2015
• Est. completion date: March 3, 2023

Study information

• Verified date: March 2023
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: March 3, 2023
• Est. primary completion date: March 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• Cholecalciferol

• Placebo of cholecalciferol

Locations

Country	Name	City	State
France	Hôpital Saint André	Bordeaux
France	Hôpital Morvan	Brest
France	Hôpital Trousseau	Chambray Les Tours
France	Centre Hospitalier	Le Mans
France	CHU de Nantes - Hôtel Dieu	Nantes
France	APHP - Hôpital Tenon	Paris
France	Centre Hospitalier	Perigueux
France	Hôpital Laënnec	Quimper
France	Hôpital Pontchaillou	Rennes
France	CHR St Brieuc	Saint Brieuc
France	Centre Hospitalier	Valenciennes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hierarchical criterion based on repeated measures of PO-SCORAD severity score	Measurement of PO-SCORAD score	2 years
Primary	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	Assessment of desease severity	Assessment of desease severity by EASI score	2 years
Secondary	Assessment of desease severity	Assessment of desease severity by IGA score	2 years
Secondary	Assessment of desease severity	Assessment of desease severity by SCORAD score	2 years
Secondary	Assessment of desease severity	Assessment of desease severity by POEM score	2 years
Secondary	Assessment of the quality of life	Assessment of the quality of life by DLQI score	2 years
Secondary	Measurement of serum Vitamin D (25-(OH)-vitamin D)		2 years
Secondary	Measurement of total IgE serum		2 years
Secondary	Assessement of number of weeks of well-controlled atopic dermatitis		2 years
Secondary	Assessment of inter-visit cumulative consumption of topical anti-inflammatory treatments		2 years
Secondary	Assessment of patient satisfaction		2 years