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

Primary Purpose

Psoriasis

Status

Withdrawn

Phase

Phase 4

Locations

Switzerland

Study Type

Interventional

Intervention

Steroid active treatment

About this trial

This is an interventional treatment trial for Psoriasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University Hospital Dermatology Department

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Steroid active treatment

Vehicle

Arm Description

Triamcinolone acetonide 0.1% in unguentum leniens topically

unguentum leniens topically

Outcomes

Primary Outcome Measures

Relapse 50% PASI after treatment, time to PASI 75% on treatment

Secondary Outcome Measures

Full Information

NCT ID

NCT01429870

First Posted

August 18, 2011

Last Updated

July 18, 2018

Sponsor

University of Zurich

1. Study Identification

Unique Protocol Identification Number

NCT01429870

Brief Title

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

Acronym

DIPSO

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)

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Withdrawn

Why Stopped

Lack of recruitment

Study Start Date

August 2011 (Actual)

Primary Completion Date

August 2016 (Actual)

Study Completion Date

August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Zurich

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psoriasis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Steroid active treatment

Arm Type

Active Comparator

Arm Description

Triamcinolone acetonide 0.1% in unguentum leniens topically

Arm Title

Vehicle

Arm Type

Placebo Comparator

Arm Description

unguentum leniens topically

Intervention Type

Drug

Intervention Name(s)

Steroid active treatment

Other Intervention Name(s)

Topical triamcinolone

Intervention Description

Triamcinolone in unguentum leniens 0.1%

Primary Outcome Measure Information:

Title

Relapse 50% PASI after treatment, time to PASI 75% on treatment

Description

Relapse 50% PASI after treatment, time to PASI 75% on treatment

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Guenther Hofbauer, MD

Organizational Affiliation

University Hospital Zurich, Division of Dermatology

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital Dermatology Department

City

Zurich

ZIP/Postal Code

8091

Country

Switzerland

12. IPD Sharing Statement

Learn more about this trial

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

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