Steroids Added to Dithranol and Narrow Band UVB(Ultraviol... | NCT01429870

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

NCT01429870

Sponsor

University of Zurich

Status

Withdrawn

Last Update Posted

Jul 19, 2018Actual

Enrollment

0Actual

Phase

Phase 4

Conditions

Psoriasis

Interventions

Steroid active treatment

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
KEK-ZH 2010-0171-5	Other Identifier	Ethical committee Zurich

Status Module

Record Verification Date

Jul 2018

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Lack of recruitment

Expanded Access Info

Start Date

Aug 2011Actual

Primary Completion Date

Aug 2016Actual

Completion Date

Aug 2016Actual

First Submitted Date

Aug 18, 2011

First Submission Date that Met QC Criteria

Sep 5, 2011

First Posted Date

Sep 7, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 18, 2018

Last Update Posted Date

Jul 19, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

(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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Steroid active treatment	Drug	Triamcinolone in unguentum leniens 0.1%	Steroid active treatment Vehicle

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Relapse 50% PASI after treatment, time to PASI 75% on treatment	Relapse 50% PASI after treatment, time to PASI 75% on treatment	2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Guenther Hofbauer, MD	University Hospital Zurich, Division of Dermatology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Dermatology Department		Zurich		8091	Switzerland

Condition Browse Module

MeSH Terms

ID	Term
D011565	Psoriasis

Ancestor Terms

ID	Term
D017444	Skin Diseases, Papulosquamous
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014221	Triamcinolone

Ancestor Terms

ID	Term
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds

Browse Leaves

Not provided

Browse Branches

Not provided