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

This study has been completed.
Sponsor:
Information provided by:
Basilea Pharmaceutica
ClinicalTrials.gov Identifier:
NCT00124436
First received: July 26, 2005
Last updated: July 16, 2010
Last verified: July 2010
  Purpose

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.


Condition Intervention Phase
Hand Dermatoses
Drug: alitretinoin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Official Title: Follow up Efficacy and Safety Study of BAL4979 in the Treatment of Chronic Hand Dermatitis Refractory to Topical Treatment

Resource links provided by NLM:


Further study details as provided by Basilea Pharmaceutica:

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

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

Estimated Enrollment: 300
Study Start Date: March 2005
Study Completion Date: February 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00124436

Locations
Germany
Thomas Ruzicka
Düsseldorf, Germany, 40225
Sponsors and Collaborators
Basilea Pharmaceutica
Investigators
Principal Investigator: Thomas Ruzicka, MD University of Düsseldorf, Dermatological Hospital, Germany
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00124436     History of Changes
Other Study ID Numbers: BAP00091
Study First Received: July 26, 2005
Last Updated: July 16, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Netherlands: Medicines Evaluation Board (MEB)
Denmark: Danish Medicines Agency
Sweden: Medical Products Agency
Finland: Finnish Medicines Agency
Czech Republic: State Institute for Drug Control
Hungary: National Institute of Pharmacy
Poland: Ministry of Health
Canada: Health Canada

Keywords provided by Basilea Pharmaceutica:
Patients who have been enrolled in study protocol BAP089, and whose severe chronic hand dermatitis responded with mild or moderate disease, or who relapsed

Additional relevant MeSH terms:
Dermatitis
Hand Dermatoses
Skin Diseases
Alitretinoin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 15, 2014