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

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00419406
• Other study ID #: 2466
• Status: Completed
• Phase: N/A
• First received: January 4, 2007
• Last updated: January 21, 2009
• Start date: March 2005
• Est. completion date: December 2007

Study information

• Verified date: January 2009
• Source: Ruhr University of Bochum
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Procedure:
• UVA1 phototherapy

• NB-UVB phototherapy

Locations

Country	Name	City	State
Germany	Department of Dermatology, Ruhr University Bochum	Bochum	NRW

Sponsors (1)

Lead Sponsor	Collaborator
Ruhr University of Bochum

Country where clinical trial is conducted

Germany, 

References & Publications (3)

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: 10.1 — View Citation

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. — View Citation

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. Epub 2006 Aug 4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical improvement during UVA1/NB-UVB phototherapy using a validated
Primary	SCORAD index
Secondary	Comparison of efficacy between UVA1 and NB-UVB phototherapy using a validated
Secondary	SCORAD index