Medium-Dose UVA1 Versus Narrow-Band UVB in Atopic Dermatitis
Primary Purpose
Atopic Dermatitis
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
UVA1 phototherapy
NB-UVB phototherapy
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis focused on measuring UVA1, N-B UVB, phototherapy, atopic dermatitis, SCORAD index
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
Sites / Locations
- Department of Dermatology, Ruhr University Bochum
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
A: UVA1
B: NB UVB
Arm Description
Outcomes
Primary Outcome Measures
Clinical improvement during UVA1/NB-UVB phototherapy using a validated
SCORAD index
Secondary Outcome Measures
Comparison of efficacy between UVA1 and NB-UVB phototherapy using a validated
SCORAD index
Full Information
NCT ID
NCT00419406
First Posted
January 4, 2007
Last Updated
January 21, 2009
Sponsor
Ruhr University of Bochum
1. Study Identification
Unique Protocol Identification Number
NCT00419406
Brief Title
Medium-Dose UVA1 Versus Narrow-Band UVB in Atopic Dermatitis
Official Title
Medium-Dose UVA1 Versus Narrow-Band UVB Phototherapy: A Randomized Double-Blind Controlled Cross-Over-Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Ruhr University of Bochum
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
UVA1, N-B UVB, phototherapy, atopic dermatitis, SCORAD index
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A: UVA1
Arm Type
Experimental
Arm Title
B: NB UVB
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
UVA1 phototherapy
Intervention Type
Procedure
Intervention Name(s)
NB-UVB phototherapy
Primary Outcome Measure Information:
Title
Clinical improvement during UVA1/NB-UVB phototherapy using a validated
Title
SCORAD index
Secondary Outcome Measure Information:
Title
Comparison of efficacy between UVA1 and NB-UVB phototherapy using a validated
Title
SCORAD index
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thilo Gambichler, MD
Organizational Affiliation
Department of Dermatology, Ruhr University Bochum
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alexander Kreuter, MD
Organizational Affiliation
Department of Dermatology, Ruhr University Bochum
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Dermatology, Ruhr University Bochum
City
Bochum
State/Province
NRW
ZIP/Postal Code
44791
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
16889943
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. doi: 10.1016/j.jdermsci.2006.06.004. Epub 2006 Aug 4. No abstract available.
Results Reference
result
PubMed Identifier
17107401
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. doi: 10.1111/j.1365-2133.2006.07481.x.
Results Reference
result
PubMed Identifier
19120333
Citation
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.
Results Reference
result
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Medium-Dose UVA1 Versus Narrow-Band UVB in Atopic Dermatitis
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