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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00124475
First Posted: July 28, 2005
Last Update Posted: July 19, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Basilea Pharmaceutica
July 26, 2005
July 28, 2005
July 19, 2010
December 2004
October 2006   (Final data collection date for primary outcome measure)
  • Physicians global assessment
  • at week 12 or 24
Same as current
Complete list of historical versions of study NCT00124475 on ClinicalTrials.gov Archive Site
  • Response rate per treatment group
  • Modified total lesion symptom score
  • Patients global assessment
  • at week 12 or 24
  • Time to relapse
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of a Retinoid for the Treatment of Severe Chronic Hand Dermatitis
Efficacy and Safety of BAL4079 in the Treatment of Severe Refractory Chronic Hand Dermatitis
The purpose of the study is to determine the therapeutic effect of alitretinoin, a retinoid, on severe, therapy refractory chronic hand dermatitis.

Chronic hand dermatitis (CHaD) is a frequent and distressing disease. Conventional treatments yield mostly unsatisfactory results. In addition, chronic hand dermatitis leads to 2-5% of all applications for permanent disability pensions in some western countries. In a therapeutic dose finding study alitretinoin was clinically effective for patients with moderate to severe chronic hand dermatitis refractory to topical treatment.

Patients with severe refractory CHaD will be allocated either of two active treatments or placebo. The primary objective is to demonstrate the response rate based on physicians global assessment of the disease.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Hand Dermatoses
Drug: alitretinoin
Not Provided
Ruzicka T, Larsen FG, Galewicz D, Horváth 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1035
September 2007
October 2006   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Chronic hand dermatitis, all types including hyperkeratotic, vesicular, fingertip dermatitis
  • Lasting for 6 months since initial diagnosis
  • Rated severe
  • Refractory to standard therapy including non-medicated therapy and avoidance of irritants and allergens
  • Refractory to topical steroids

Exclusion Criteria:

  • Female patients who are pregnant or want to become pregnant
  • Female patients of child bearing potential who cannot use or will not commit to using two effective forms of contraception simultaneously
  • Patients whose disease is adequately controlled by standard non-medicated therapy and standard corticosteroid therapy
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00124475
BAP00089
Not Provided
Not Provided
Not Provided
Not Provided
Basilea Pharmaceutica
Not Provided
Principal Investigator: Thomas Ruzicka, MD University of Düsseldorf, Dermatological Hospital, Germany
Basilea Pharmaceutica
July 2010

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