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Dermatitis |
Types of dermatitis; Contact Dermatitis; Dermatitis-Atopic Eczema; Dermatitis/Eczema; Rash; Skin Disorders, Dermatitis; Skin Rash; Slide Show: Types of Dermatitis |
Clinical Trial: Efficacy and Safety of a Retinoid for the Treatment of Severe Chronic Hand Dermatitis
This study is currently recruiting patients.
Verified by Basilea Pharmaceutica July 2005
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Purpose
The purpose of the study is to determine the therapeutic effect of alitretinoin, a retinoid, on severe, therapy refractory chronic hand dermatitis.
| Condition | Intervention | Phase |
|---|---|---|
| Chronic Hand Dermatitis | Drug: alitretinoin | Phase III |
MedlinePlus related topics: Eczema
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Efficacy and Safety of BAL4079 in the Treatment of Severe Refractory Chronic Hand Dermatitis
Further Study Details:
Primary Outcomes: Physicians Global Assessment; at week 12 or 24
Secondary Outcomes: Response rate per treatment group; Modified total lesion symptom score; Patients global assessment; at week 12 or 24; Time to relapse
Expected Total Enrollment: 1035
Secondary Outcomes: Response rate per treatment group; Modified total lesion symptom score; Patients global assessment; at week 12 or 24; Time to relapse
Expected Total Enrollment: 1035
Study start: December 2004
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.
Eligibility
Ages Eligible for Study: 18 Years - 75 Years, Genders Eligible for Study: Both
Criteria
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
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00124475
Jürgen Maares, MD +41 616061-111 Ext. 229 juergen.maares@basilea.com
Germany
Thomas Ruzicka, Düsseldorf, 40225, Germany; Recruiting
, MD
Study chairs or principal investigators
Thomas Ruzicka, MD, Principal Investigator, University of Düsseldorf, Dermatological Hospital, Germany
More Information
Publications
Ruzicka T, Larsen FG, Galewicz D, Horvath 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.
Study ID Numbers: BAP089
Last Updated: August 1, 2005
Record first received: July 27, 2005
ClinicalTrials.gov Identifier: NCT00124475
Health Authority: Germany: Federal Institute for Drugs and Medicinal Devices; Finland: National Agency for Medicines; France: Afssaps - French Health Products Safety Agency; Denmark: Danish Medicines Agency; Poland: Ministry of Health; Hungary: National Institute of Pharmacy; Sweden: Medical Products Agency; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Netherlands: Medicines Evaluation Board (MEB); Czech Republic: State Institute for Drug Control; Canada: Health Canada
ClinicalTrials.gov processed this record on 2005-08-02
Last Updated: August 1, 2005
Record first received: July 27, 2005
ClinicalTrials.gov Identifier: NCT00124475
Health Authority: Germany: Federal Institute for Drugs and Medicinal Devices; Finland: National Agency for Medicines; France: Afssaps - French Health Products Safety Agency; Denmark: Danish Medicines Agency; Poland: Ministry of Health; Hungary: National Institute of Pharmacy; Sweden: Medical Products Agency; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Netherlands: Medicines Evaluation Board (MEB); Czech Republic: State Institute for Drug Control; Canada: Health Canada
ClinicalTrials.gov processed this record on 2005-08-02
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