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Clinical Trials/NCT00419406
NCT00419406
Completed
Not Applicable

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

Ruhr University of Bochum1 site in 1 country28 target enrollmentMarch 2005

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Atopic Dermatitis
Sponsor
Ruhr University of Bochum
Enrollment
28
Locations
1
Primary Endpoint
Clinical improvement during UVA1/NB-UVB phototherapy using a validated
Status
Completed
Last Updated
17 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
March 2005
End Date
December 2007
Last Updated
17 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Ruhr University of Bochum

Eligibility Criteria

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

Outcomes

Primary Outcomes

Clinical improvement during UVA1/NB-UVB phototherapy using a validated

SCORAD index

Secondary Outcomes

  • Comparison of efficacy between UVA1 and NB-UVB phototherapy using a validated
  • SCORAD index

Study Sites (1)

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