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

March 30, 2006
July 16, 2010
April 2006
April 2007   (final data collection date for primary outcome measure)
  • Safety:
  • Adverse Events
  • Safety Laboratory
  • Radiological investigations (bone density, x-ray)
Same as current
Complete list of historical versions of study NCT00309621 on ClinicalTrials.gov Archive Site
  • Physicians Global Assessment
  • modified Total Lesion Symptom Score
  • Patients Global Assessment
  • Patient Defined Outcomes
Same as current
Not Provided
Not Provided
 
Safety and Efficacy of a Retinoid for the Treatment of Severe Chronic Hand Dermatitis
Safety and Efficacy of Alitretinoin in the Treatment of Severe Refractory Chronic Hand Dermatitis

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.

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.

Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hand Dermatoses
Drug: alitretinoin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
250
May 2007
April 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Germany,   Poland
 
NCT00309621
BAP00626
Not Provided
Not Provided
Basilea Pharmaceutica
Not Provided
Principal Investigator: Thomas Diepgen, MD Univ. Heidelberg
Basilea Pharmaceutica
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP