NCT01429870

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2011

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

August 18, 2011

Completed
20 days until next milestone

First Posted

Study publicly available on registry

September 7, 2011

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

July 19, 2018

Status Verified

July 1, 2018

Enrollment Period

5 years

First QC Date

August 18, 2011

Last Update Submit

July 18, 2018

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

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

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

    2 years

Study Arms (2)

Steroid active treatment

ACTIVE COMPARATOR

Triamcinolone acetonide 0.1% in unguentum leniens topically

Drug: Steroid active treatment

Vehicle

PLACEBO COMPARATOR

unguentum leniens topically

Drug: Steroid active treatment

Interventions

Steroid active treatmentDRUG

Triamcinolone in unguentum leniens 0.1%

Also known as: Topical triamcinolone
Steroid active treatmentVehicle

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Moderate to severe psoriasis of the chronic-plaque and / or guttata type

You may not qualify if:

  • Participation in a Goeckerman therapy regimen within 6 months previous to the present study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Dermatology Department

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Psoriasis

Interventions

Triamcinolone

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

PregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Guenther Hofbauer, MD

    University Hospital Zurich, Division of Dermatology

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2011

First Posted

September 7, 2011

Study Start

August 1, 2011

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

July 19, 2018

Record last verified: 2018-07

Locations

CH(1)