Steroids Added to Dithranol and Narrow Band UVB(Ultraviolet B) (UVBnb) in Psoriasis (DIPSO)

July 18, 2018 updated by: University of Zurich

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

Status

Withdrawn

Conditions

Intervention / Treatment

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

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zurich, Switzerland, 8091
        • University Hospital Dermatology Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Drug: Steroid active treatment
Triamcinolone in unguentum leniens 0.1%
Other Names:
  • Topical triamcinolone
Placebo Comparator: Vehicle
unguentum leniens topically
Drug: Steroid active treatment
Triamcinolone in unguentum leniens 0.1%
Other Names:
  • Topical triamcinolone

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

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Investigators

  • Principal Investigator: Guenther Hofbauer, MD, University Hospital Zurich, Division of Dermatology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2011

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

August 18, 2011

First Submitted That Met QC Criteria

September 5, 2011

First Posted (Estimate)

September 7, 2011

Study Record Updates

Last Update Posted (Actual)

July 19, 2018

Last Update Submitted That Met QC Criteria

July 18, 2018

Last Verified

July 1, 2018

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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