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

May 9, 2023 updated by: Basilea Pharmaceutica

Follow up Efficacy and Safety Study of BAL4979 in the Treatment of Chronic Hand Dermatitis Refractory to Topical Treatment

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

300

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Düsseldorf, Germany, 40225
        • Thomas Ruzicka

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Patient's global assessment
Extent of disease
Time to respond
Modified total lesion symptom score
at week 12 or 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Basilea Pharmaceutica

Investigators

  • Principal Investigator: Thomas Ruzicka, MD, University of Düsseldorf, Dermatological Hospital, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Primary Completion (Actual)

January 1, 2007

Study Completion (Actual)

February 1, 2007

Study Registration Dates

First Submitted

July 26, 2005

First Submitted That Met QC Criteria

July 27, 2005

First Posted (Estimate)

July 28, 2005

Study Record Updates

Last Update Posted (Actual)

May 10, 2023

Last Update Submitted That Met QC Criteria

May 9, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BAP00091

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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