Follow-up Efficacy and Safety of Alitretinoin in Severe C... | NCT00124436

Studies
Follow-up Efficacy and Safety of Alitretinoin in Severe Chronic Hand Dermatitis

NCT00124436

Sponsor

Basilea Pharmaceutica

Status

Completed

Last Update Posted

May 10, 2023Actual

Enrollment

300

Phase

Phase 3

Conditions

Hand Dermatoses

Interventions

alitretinoin

Countries

Germany

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

Status Module

Record Verification Date

May 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2005

Primary Completion Date

Jan 2007Actual

Completion Date

Feb 2007Actual

First Submitted Date

Jul 26, 2005

First Submission Date that Met QC Criteria

Jul 27, 2005

First Posted Date

Jul 28, 2005Estimated

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

May 9, 2023

Last Update Posted Date

May 10, 2023Actual

Description Module

Brief Summary

Patients who have been treated in study protocol BAP089 may have responded to treatment, and subsequently relapsed to >75% of the baseline disease severity, will be investigated for response to further treatment with alitretinoin. Also, patients who have responded with mild or moderate disease will be investigated for additional treatment effect after prolongated treatment.

Detailed Description

Not provided

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300

Name	Type	Description	Arm Group Labels	Other Names
alitretinoin	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Response of chronic hand dermatitis to study treatment as assessed by Physicians Global Assessment, at week 12 or 24

Secondary Outcomes

Measure	Description	Time Frame
Patient's global assessment
Extent of disease
Time to respond

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Previous participation in protocol BAP089
Response of severe, treatment refractory hand dermatitis with mild or moderate, or responding patients who relapsed to 75% of baseline disease

Exclusion Criteria:

Female patients who are pregnant or who want to become pregnant
Female patients of child bearing potential who cannot use or who will not commit to using two effective methods of contraception

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Thomas Ruzicka, MD	University of Düsseldorf, Dermatological Hospital, Germany	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Thomas Ruzicka		Düsseldorf		40225	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15611422	Background	Ruzicka T, Larsen FG, Galewicz D, Horvath A, Coenraads PJ, Thestrup-Pedersen K, Ortonne JP, Zouboulis CC, Harsch M, Brown TC, Zultak M. Oral alitretinoin (9-cis-retinoic acid) therapy for chronic hand dermatitis in patients refractory to standard therapy: results of a randomized, double-blind, placebo-controlled, multicenter trial. Arch Dermatol. 2004 Dec;140(12):1453-9. doi: 10.1001/archderm.140.12.1453.

ID	Term
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

ID	Term
D014212	Tretinoin
D014801	Vitamin A
D012176	Retinoids
D002338	Carotenoids
D011090