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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01402414 |
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Date of registration:
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19/07/2011 |
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Primary sponsor: |
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Public title:
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Narrow-band (NB)-UVB vs. Bath-PUVA and NB-UVB Plus Salt Water Baths in Atopic Dermatitis
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Scientific title:
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Study Comparing the Effectiveness of Narrow-band UVB vs. Bath-PUVA and Narrow-band UVB + Salt Water Baths in Atopic Dermatitis |
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Date of first enrolment:
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April 2011 |
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Target sample size:
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50 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01402414 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
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Countries of recruitment
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Germany
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Contacts
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Name:
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Sarah Terras, MD |
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Address:
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Telephone:
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0049 234 509 3427 |
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Email:
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s.terras@klinikum-bochum.de |
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Affiliation:
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Name:
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Thilo Gambichler, adjunct professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Ruhr University Bochum |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients with moderate to severe disease AD with SASSAD-Score > 25
- Age > 18 years
- No topical steroids or topical/systemic antibiotics 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
- severe cardiovascular disease
- intense UV radiation (tanning beds, sun exposure, phototherapy, etc.) 8 weeks before
the start of the study
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Atopic Dermatitis
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Intervention(s)
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Radiation: Bath-PUVA
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Radiation: NB-UVB
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Radiation: NB-UVB plus salt water baths
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Primary Outcome(s)
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Clinical improvement after treatments using a validated SASSAD index
[Time Frame: Evaluation at baseline and after 4-week treatment, 3 months follow-up]
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Secondary Outcome(s)
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Evaluation of pruritus and sleeplessness visual analogue scales
[Time Frame: Evaluation at baseline and after 4-week treatment, 3 months follow-up]
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Immunohistochemical, RT-PCR and serological parameters
[Time Frame: Evaluation at baseline and after 4-week treatment]
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Measuring quality of life using the Skindex-29
[Time Frame: Evaluation at baseline and after 4-week treatment, 3 months follow-up]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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