PRAgmatic trial, Multicentre, cross-over, evaluating in patients with atopic dermatitis the long-term control effectiveness of new phototherapy regimen during winter, in supplement of standard topical treatmements, with oral vitamin D supplementation or not

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 - PRADA

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-000881-73-FR

Enrollment

200

Registered

2015-07-29

Start date

2015-07-27

Completion date

Unknown

Last updated

2019-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis MedDRA version: 18.0 Level: HLT Classification code 10012435 Term: Dermatitis and eczema System Organ Class: 100000004858

Interventions

Trade Name: UVEDOSE Product Name: Vitamine D Pharmaceutical Form: Oral liquid Pharmaceutical form of the placebo: Oral solution Route of

Eligibility

Sex/Gender

All

Inclusion 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), - Written informed consent of the patient - For patients aged between 15 and 18, written informed consent of the parents and of the teenager. Are the trial subjects under 18? yes Number of subjects for this age range: 50 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 150 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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 skin cancer (melanoma, squamous cell skin cancer, basal cell skin cancer), lupus, dermatomyositis, any other photosensitizing skin disease, photosensitizing medication), - More than 100 previous phototherapy sessions in lifetime, - Other trial standard exclusion criteria (pregnancy…), - Persons subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate a new phototherapy-based regimen as an add-on therapy (i.e., in addition to topical anti-inflammatory treatments) on atopic dermatitis long-term control in patients with atopic dermatitis aged 15 years or more with > 2 years of disease evolution, with moderate-to-severe disease (IGA > 2) in a primary care population in combination with vitamin D supplementation or not.; Secondary Objective: - To compare vitamin D supplementation as an add-on therapy vs. placebo on long term efficacy control, - To compare randomisation groups for all secondary outcome criteria (patient-reported outcomes, TAT consumption, quality of life, patient satisfaction, adverse events, and adherence to trial interventions) in winter and all-year-round, - To explore the interplay and interaction between vitamin D and phototherapy on disease control and on serum vitamin D levels in winter and all-year-round, - To describe patterns of disease and TAT consumption in relation with disease severity, and socio-demographic factors, - To investigate temporal (seasonality) and regional differences for relevant outcome criteria, - To assess the impact of regional weather and individual natural solar exposure on serum vitamin D levels in the context of presence or absence of vitamin D supplementation and phototherapy. ;Primary end point(s): Hierarchical criterion based on: (1) repeated measures of PO-SCORAD severity score over 1 year; (2) cumulative consumption of TAT (collected tubes) during winter.; Timepoint(s) of evaluation of this end point: PO-SCORAD: every month during 2 years TAT consumption: every 3 months during 2 years	—

Measure

Time frame

Main Objective: To evaluate a new phototherapy-based regimen as an add-on therapy (i.e., in addition to topical anti-inflammatory treatments) on atopic dermatitis long-term control in patients with atopic dermatitis aged 15 years or more with > 2 years of disease evolution, with moderate-to-severe disease (IGA > 2) in a primary care population in combination with vitamin D supplementation or not.; Secondary Objective: - To compare vitamin D supplementation as an add-on therapy vs. placebo on long term efficacy control, - To compare randomisation groups for all secondary outcome criteria (patient-reported outcomes, TAT consumption, quality of life, patient satisfaction, adverse events, and adherence to trial interventions) in winter and all-year-round, - To explore the interplay and interaction between vitamin D and phototherapy on disease control and on serum vitamin D levels in winter and all-year-round, - To describe patterns of disease and TAT consumption in relation with disease severity, and socio-demographic factors, - To investigate temporal (seasonality) and regional differences for relevant outcome criteria, - To assess the impact of regional weather and individual natural solar exposure on serum vitamin D levels in the context of presence or absence of vitamin D supplementation and phototherapy. ;Primary end point(s): Hierarchical criterion based on: (1) repeated measures of PO-SCORAD severity score over 1 year; (2) cumulative consumption of TAT (collected tubes) during winter.; Timepoint(s) of evaluation of this end point: PO-SCORAD: every month during 2 years TAT consumption: every 3 months during 2 years

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Secondary

Measure	Time frame
Secondary end point(s): Repeated measures over 2 years for: 1 - Investigator-based severity scores (EASI, SCORAD, IGA) 2 - Patient-reported severity and quality of life validated scores (POEM, DLQI), 3 - Serum Vitamin D (25-(OH)-vitamin D) levels, 4 - Total IgE serum levels, 5 - Number of weeks of well-controlled AD, 6 - Inter-visit cumulative consumption TAT, 7 - Patient-reported satisfaction at the end of each winter. ; Timepoint(s) of evaluation of this end point: 1 - every 3 months during 2 years 2 - POEM : every month during 2 years DLQI : every 3 months during 2 years 3 - every 3 months during 2 years 4 - every 3 months during 2 years 5 - 2 years 6 - every 3 months during 2 years 7 - every year during 2 years	—

Measure

Time frame

Secondary end point(s): Repeated measures over 2 years for: 1 - Investigator-based severity scores (EASI, SCORAD, IGA) 2 - Patient-reported severity and quality of life validated scores (POEM, DLQI), 3 - Serum Vitamin D (25-(OH)-vitamin D) levels, 4 - Total IgE serum levels, 5 - Number of weeks of well-controlled AD, 6 - Inter-visit cumulative consumption TAT, 7 - Patient-reported satisfaction at the end of each winter. ; Timepoint(s) of evaluation of this end point: 1 - every 3 months during 2 years 2 - POEM : every month during 2 years DLQI : every 3 months during 2 years 3 - every 3 months during 2 years 4 - every 3 months during 2 years 5 - 2 years 6 - every 3 months during 2 years 7 - every year during 2 years

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Countries

France

Contacts

Public ContactVisseiche

CHU de Rennes

valerie.visseiche@chu-rennes.fr33299 28 97 47

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026