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

This study has suspended participant recruitment.
(Lack of recruitment)
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01429870
First received: August 18, 2011
Last updated: December 9, 2015
Last verified: December 2015
  Purpose

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

Condition Intervention Phase
Psoriasis
Drug: Steroid active treatment
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • Relapse 50% PASI after treatment, time to PASI 75% on treatment [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Relapse 50% PASI after treatment, time to PASI 75% on treatment


Estimated Enrollment: 88
Study Start Date: August 2011
Estimated Study Completion Date: August 2021
Estimated Primary Completion Date: August 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Steroid active treatment
Triamcinolone acetonide 0.1% in unguentum leniens topically
Drug: Steroid active treatment
Triamcinolone in unguentum leniens 0.1%
Other Name: Topical triamcinolone
Placebo Comparator: Vehicle
unguentum leniens topically
Drug: Steroid active treatment
Triamcinolone in unguentum leniens 0.1%
Other Name: Topical triamcinolone

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
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01429870

Locations
Switzerland
University Hospital Dermatology Department
Zurich, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Guenther Hofbauer, MD University Hospital Zurich, Division of Dermatology
  More Information

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01429870     History of Changes
Other Study ID Numbers: DIPSO  KEK-ZH 2010-0171-5 
Study First Received: August 18, 2011
Last Updated: December 9, 2015
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Anthralin
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Dermatologic Agents

ClinicalTrials.gov processed this record on August 23, 2016