Medium-Dose UVA1 Versus Narrow-Band UVB in Atopic Dermatitis

Study Overview
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Brief Summary
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Atopic dermatitis (AD) is a very common disorder that is characterized by pruritic inflammatory skin lesions, with patients usually having an individual or family history of atopic diseases in their background. Phototherapy is among the first-line approaches in the management of AD. In this context, a variety of studies have shown a beneficial effect of natural or artificial UV radiation in atopic dermatitis (AD). The past ten years have seen the introduction of new phototherapeutic regimens for AD, including UVA1 and NB-UVB.UVA1 seems to be more effective than the above mentioned broadband spectra, in particular in acute severe AD. The aim of the present study is the comparison of UVA1 and NB-UVB phototherapy in the treatment of AD. Additionally, the course of several cytokines, human beta-defensins, and SMAD-proteins will be evaluated during the course of treatment.

Detailed Description
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Atopic dermatitis (AD) is a very common disorder that is characterized by pruritic inflammatory skin lesions, with patients usually having an individual or family history of atopic diseases in their background (e.g., allergic asthma and rhinitis). Defective skin barrier, immunological dysfunctions (type I and IV allergy), genetic disorders, and psychological factors contribute to the pathogenesis of AD. However, among these factors, CD4+ Th cells are reported to play a particularly crucial role in the pathogenesis of AD. Phototherapy is among the first-line approaches in the management of AD. In this context, a variety of studies have shown a beneficial effect of natural or artificial UV radiation in atopic dermatitis (AD). Different broadband UV spectra (BB-UVA, BB-UVB, BB-UVA/BB-UVB) and combined treatment modalities such as balneophototherapy and PUVA have previously been proven to be effective in AD. However the past ten years have seen the introduction of new phototherapeutic regimens for AD, including UVA1 and NB-UVB.UVA1 seems to be more effective than the above mentioned broadband spectra, in particular in acute severe AD. The aim of the present study is the comparison of UVA1 and NB-UVB phototherapy in the treatment of AD. Additionally, the course of several cytokines, human beta-defensins, and SMAD-proteins will be evaluated during the course of treatment.

Official Title
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Medium-Dose UVA1 Versus Narrow-Band UVB Phototherapy: A Randomized Double-Blind Controlled Cross-Over-Study

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Procedure: UVA1 phototherapy
* Procedure: NB-UVB phototherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with chronic AD (Hanifin and Rajka, 1980); moderate to severe disease with SCORAD-index > 30 (maximum = 102). Age > 18 years No topical steroids (except 1% hydrocortisone) or topical/systemic antibiotics or antihistamines within the last 2 weeks, no systemic glucocorticosteroids or other immunosuppressive agents within the last 8 weeks, no phototherapy within the last 12 weeks before inclusion Exclusion Criteria: Pregnancy or lactation Skin cancer or dysplastic naevi, photosensitive skin diseases, autoimmune diseases or relevant cardiovascular diseases Photo-skin type I according to Fitzpatrick

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A: UVA1<br> | Procedure: UVA1 phototherapy<br> <br> |
| Experimental: B: NB UVB<br> | Procedure: NB-UVB phototherapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical improvement during UVA1/NB-UVB phototherapy using a validated |  |  | 
| SCORAD index |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of efficacy between UVA1 and NB-UVB phototherapy using a validated |  |  | 
| SCORAD index |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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UVA1, N-B UVB, phototherapy, atopic dermatitis, SCORAD index