Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by:
Basilea Pharmaceutica
ClinicalTrials.gov Identifier:
NCT00309621
First received: March 30, 2006
Last updated: July 16, 2010
Last verified: July 2010
  Purpose

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.


Condition Intervention Phase
Hand Dermatoses
Drug: alitretinoin
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Alitretinoin in the Treatment of Severe Refractory Chronic Hand Dermatitis

Resource links provided by NLM:


Further study details as provided by Basilea Pharmaceutica:

Primary Outcome Measures:
  • Safety:
  • Adverse Events
  • Safety Laboratory
  • Radiological investigations (bone density, x-ray)

Secondary Outcome Measures:
  • Physicians Global Assessment
  • modified Total Lesion Symptom Score
  • Patients Global Assessment
  • Patient Defined Outcomes

Estimated Enrollment: 250
Study Start Date: April 2006
Study Completion Date: May 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT00309621

Locations
Canada, Alberta
Edmonton, Alberta, Canada, T6G2G3
Canada, British Columbia
Vancouver, British Columbia, Canada, V5O3Y1
Canada, Manitoba
Winnipeg, Manitoba, Canada, R3C1R4
Canada, Ontario
Hawkesbury, Ontario, Canada, K6A1A1
London, Ontario, Canada, N6H1S9
Markham, Ontario, Canada, L3P1A8
Oakville, Ontario, Canada, L6J7W5
Canada, Quebec
Montreal, Quebec, Canada, H3X1V6
Sheerbroke, Quebec, Canada, J1H1Z1
Canada
Quebec, Canada, G1J1X7
Germany
Berlin, Germany, 13439
Berlin, Germany, 12353
Frankfurt, Germany, 60326
Hamburg, Germany, 22143
Hamburg, Germany, 20246
Hamburg, Germany, 20354
Abt. Klinische Sozialmedizin
Heidelberg, Germany, 69115
Ibbenbüren, Germany, 49477
Köln, Germany, 51143
Lübeck, Germany, 23558
Mönchengladbach, Germany, 41061
München, Germany, 81375
Münster, Germany, 48143
Osnabrück, Germany, 49078
Potsdam, Germany, 14482
Viersen, Germany, 41747
Wuppertal, Germany, 42275
Poland
Gdansk, Poland
Krakow, Poland, 31-462
Lublin, Poland
Opole, Poland, 45-372
Szcecin, Poland
Wroclaw, Poland
Sponsors and Collaborators
Basilea Pharmaceutica
Investigators
Principal Investigator: Thomas Diepgen, MD Univ. Heidelberg
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00309621     History of Changes
Other Study ID Numbers: BAP00626
Study First Received: March 30, 2006
Last Updated: July 16, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Canada: Health Canada
Poland: Ministry of Health

Keywords provided by Basilea Pharmaceutica:
Hand Dermatoses,
hand dermatitis
hand eczema
chronic hand dermatitis
retinoid

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

ClinicalTrials.gov processed this record on November 23, 2014