NCT00419406

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2005

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

January 4, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 8, 2007

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

January 22, 2009

Status Verified

January 1, 2009

Enrollment Period

2.8 years

First QC Date

January 4, 2007

Last Update Submit

January 21, 2009

Conditions

Atopic Dermatitis

Keywords

UVA1N-B UVBphototherapyatopic dermatitisSCORAD index

Outcome Measures

Primary Outcomes (2)

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

  • SCORAD index

Secondary Outcomes (2)

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

  • SCORAD index

Study Arms (2)

A: UVA1

EXPERIMENTAL
Procedure: UVA1 phototherapy

B: NB UVB

EXPERIMENTAL
Procedure: NB-UVB phototherapy

Interventions

UVA1 phototherapyPROCEDURE
A: UVA1
NB-UVB phototherapyPROCEDURE
B: NB UVB

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with chronic AD (Hanifin and Rajka, 1980); moderate to severe disease with SCORAD-index \> 30 (maximum = 102).
  • Age \> 18 years

You may not qualify if:

  • Pregnancy or lactation
  • Skin cancer or dysplastic naevi, photosensitive skin diseases, autoimmune diseases or relevant cardiovascular diseases
  • Photo-skin type I according to Fitzpatrick

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Dermatology, Ruhr University Bochum

Bochum, North Rhine-Westphalia, 44791, Germany

Location

Related Publications (3)

  • 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.

    PMID: 16889943RESULT

  • 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.

    PMID: 17107401RESULT

  • 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.

    PMID: 19120333RESULT

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Thilo Gambichler, MD

    Department of Dermatology, Ruhr University Bochum

    PRINCIPAL INVESTIGATOR

  • Alexander Kreuter, MD

    Department of Dermatology, Ruhr University Bochum

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 4, 2007

First Posted

January 8, 2007

Study Start

March 1, 2005

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

January 22, 2009

Record last verified: 2009-01

Locations

DE(1)