Safety and Efficacy of a Retinoid for the Treatment of Severe Chronic Hand Dermatitis - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

March 30, 2006

Last Updated Date

January 17, 2008

Start Date ^†

April 2006

Current Primary Outcome Measures ^†

Safety:
Adverse Events
Safety Laboratory
Radiological investigations (bone density, x-ray)

Original Primary Outcome Measures ^†

Safety:
Adverse Events
Safety Laboratory
Radiological investigations (bone density, x-ray)

Change History

Complete list of historical versions of study NCT00309621 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Physicians Global Assessment
modified Total Lesion Symptom Score
Patients Global Assessment
Patient Defined Outcomes

Original Secondary Outcome Measures ^†

Physicians Global Assessment
modified Total Lesion Symptom Score
Patients Global Assessment
Patient Defined Outcomes

Descriptive Information

Brief Title ^†

Safety and Efficacy of a Retinoid for the Treatment of Severe Chronic Hand Dermatitis

Official Title ^†

Safety and Efficacy of Alitretinoin in the Treatment of Severe Refractory Chronic Hand Dermatitis

Brief Summary

Patients with severe chronic hand dermatitis, that has not responded to topical treatment, including topical steroids and the avoidance of aggravating factors, will be treated with the oral medication alitretinoin. The study aims to investigate the safety and efficacy of the medication when given over a period of 6 months.

Detailed Description

For severe, chronic hand dermatitis, refractory to topical treatment and the avoidance of aggravating factors such as allergens and irritants, no registered systemic treatment is available. Current systemic treatment options consist in the off-label use of systemic immune suppressants, such as cyclosporine, methotrexate. Severe chronic hand dermatitis is a debilitating disease, with massive impact on social life and working ability. A huge proportion of the population suffers for more than a decade, and job losses are a frequent consequence. This open-label trial investigates the safety and efficacy of oral alitretinoin 30mg as a single daily dose for up to 6 months. The trial is complementary to the pivotal efficacy study BAP00089.

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^†

Hand Dermatoses

Intervention ^†

Drug: alitretinoin

Study Arms / Comparison Groups

Publications *

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

250

Completion Date

May 2007

Primary Completion Date

April 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

Inclusion Criteria:

Chronic hand dermatitis, rated as severe by physicians global assessment, present for at least 6 months, that has not responded to the avoidance of allergens and irritants and the use of topical steroids

Exclusion Criteria:

female of childbearing potential, unless participating in a pregnancy prevention program
psoriasis
active major psychiatric condition

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Canada, Germany, Poland

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00309621

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Basilea Pharmaceutica

Collaborators ^††

Investigators ^†

Principal Investigator:

Thomas Diepgen, MD

Univ. Heidelberg

Information Provided By

Basilea Pharmaceutica

Verification Date

January 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.