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| ID | Type | Description | Link |
|---|---|---|---|
| 35RC14_9754_PRADA | Other Identifier | CHU de Rennes |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cholecalciferol | Active Comparator | 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) |
|
| Placebo of cholecalciferol | Placebo Comparator | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cholecalciferol | Drug |
|
| |
| Placebo of cholecalciferol |
| Measure | Description | Time Frame |
|---|---|---|
| Hierarchical criterion based on repeated measures of PO-SCORAD severity score | Measurement of PO-SCORAD score | 2 years |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of desease severity | Assessment of desease severity by EASI score | 2 years |
| Assessment of desease severity | Assessment of desease severity by IGA score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Catherine Droitcourt | Rennes University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Saint André | Bordeaux | 33075 | France | |||
| Hôpital Morvan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30909923 | Derived | 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. |
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| Drug |
|
|
| 2 years |
| Assessment of desease severity | Assessment of desease severity by SCORAD score | 2 years |
| Assessment of desease severity | Assessment of desease severity by POEM score | 2 years |
| Assessment of the quality of life | Assessment of the quality of life by DLQI score | 2 years |
| 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 |
| Brest |
| 29609 |
| France |
| Hôpital Trousseau | Chambray-lès-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 | Périgueux | 24000 | France |
| Hôpital Laënnec | Quimper | 29107 | France |
| Hôpital Pontchaillou | Rennes | 35033 | France |
| CHR St Brieuc | Saint-Brieuc | 22000 | France |
| Centre Hospitalier | Valenciennes | 59322 | France |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
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