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

NCT ID: NCT00419406

Last Updated: 2009-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2007-12-31

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.

Conditions

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Atopic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A: UVA1

Group Type EXPERIMENTAL

UVA1 phototherapy

Intervention Type PROCEDURE

B: NB UVB

Group Type EXPERIMENTAL

NB-UVB phototherapy

Intervention Type PROCEDURE

Interventions

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UVA1 phototherapy

Intervention Type PROCEDURE

NB-UVB phototherapy

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ruhr University of Bochum

OTHER

Sponsor Role lead

Responsible Party

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Department of Dermatology, Ruhr University of Bochum

Principal Investigators

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Thilo Gambichler, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Dermatology, Ruhr University Bochum

Alexander Kreuter, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Dermatology, Ruhr University Bochum

Locations

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Department of Dermatology, Ruhr University Bochum

Bochum, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

References

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Gambichler T, Tomi NS, Skrygan M, Altmeyer P, Kreuter A. Alterations of TGF-beta/Smad mRNA expression in atopic dermatitis following narrow-band ultraviolet B phototherapy: results of a pilot study. J Dermatol Sci. 2006 Oct;44(1):56-8. doi: 10.1016/j.jdermsci.2006.06.004. Epub 2006 Aug 4. No abstract available.

Reference Type RESULT
PMID: 16889943 (View on PubMed)

Gambichler T, Skrygan M, Tomi NS, Altmeyer P, Kreuter A. Changes of antimicrobial peptide mRNA expression in atopic eczema following phototherapy. Br J Dermatol. 2006 Dec;155(6):1275-8. doi: 10.1111/j.1365-2133.2006.07481.x.

Reference Type RESULT
PMID: 17107401 (View on PubMed)

Gambichler T, Othlinghaus N, Tomi NS, Holland-Letz T, Boms S, Skrygan M, Altmeyer P, Kreuter A. Medium-dose ultraviolet (UV) A1 vs. narrowband UVB phototherapy in atopic eczema: a randomized crossover study. Br J Dermatol. 2009 Mar;160(3):652-8. doi: 10.1111/j.1365-2133.2008.08984.x. Epub 2008 Dec 11.

Reference Type RESULT
PMID: 19120333 (View on PubMed)

Other Identifiers

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2466

Identifier Type: -

Identifier Source: org_study_id

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