NCT02537509

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 111 (actual)
• Sponsor: Rennes University Hospital · Academic / Other
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	Cholecalciferol
DRUG	Placebo of cholecalciferol

Timeline

• Start date: 2015-10-27
• Primary completion: 2023-03-03
• Completion: 2023-03-03
• First posted: 2015-09-01
• Last updated: 2023-03-23

Locations

11 sites across 1 country: France