- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01429870
Steroids Added to Dithranol and Narrow Band UVB(Ultraviolet B) (UVBnb) in Psoriasis (DIPSO)
A Phase IV, Randomized, Double Blind, Placebo Controlled, Single-center Study of the Impact of Topical Steroids on Narrow Band UVB (Ultraviolet B) and Dithranol Combination Treatment of Psoriasis (DIPSO)
Objective(s):
(i) To assess the effect of adjunctive topical steroids in the combined treatment with UVBnb and dithranol on the remission time after therapy till a relapse of psoriasis defined as 50% loss of PASI (Psoriasis Area and Severity Index) improvement obtained through the antecedent treatment.
(ii) To assess the impact of adjuvant topical steroids in the combined treatment with UVBnb and dithranol on the clearing time of psoriasis lesions under therapy (PASI 75).
- Trial with medicinal product
Study Overview
Detailed Description
(i) To assess the effect of adjunctive topical steroids in the combined treatment with UVBnb and dithranol on the remission time after therapy till a relapse of psoriasis defined as 50% loss of PASI (Psoriasis Area and Severity Index) improvement obtained through the antecedent treatment.
(ii) To assess the impact of adjuvant topical steroids in the combined treatment with UVBnb and dithranol on the clearing time of psoriasis lesions under therapy (PASI 75).
- Trial with medicinal product
Study Type
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
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Zurich, Switzerland, 8091
- University Hospital Dermatology Department
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria:
- Moderate to severe psoriasis of the chronic-plaque and / or guttata type
Exclusion criteria:
- Participation in a Goeckerman therapy regimen within 6 months previous to the present study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Steroid active treatment
Triamcinolone acetonide 0.1% in unguentum leniens topically
|
Triamcinolone in unguentum leniens 0.1%
Other Names:
|
Placebo Comparator: Vehicle
unguentum leniens topically
|
Triamcinolone in unguentum leniens 0.1%
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Relapse 50% PASI after treatment, time to PASI 75% on treatment
Time Frame: 2 years
|
Relapse 50% PASI after treatment, time to PASI 75% on treatment
|
2 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Guenther Hofbauer, MD, University Hospital Zurich, Division of Dermatology
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DIPSO
- KEK-ZH 2010-0171-5 (Other Identifier: Ethical committee Zurich)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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