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

Hand Dermatoses Clinical Trial

Official title:

Efficacy and Safety of BAL4079 in the Treatment of Severe Refractory Chronic Hand Dermatitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00124475
• Other study ID #: BAP00089
• Status: Completed
• Phase: Phase 3
• Start date: December 2004
• Est. completion date: September 2007

Study information

• Verified date: May 2023
• Source: Basilea Pharmaceutica
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to determine the therapeutic effect of alitretinoin, a retinoid, on severe, therapy refractory chronic hand dermatitis.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1035
• Est. completion date: September 2007
• Est. primary completion date: October 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Dermatitis
• Hand Dermatoses
• Skin Diseases

Intervention

Drug:
• alitretinoin

Locations

Country	Name	City	State
Germany	Thomas Ruzicka, MD	Düsseldorf

Sponsors (1)

Lead Sponsor	Collaborator
Basilea Pharmaceutica

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. doi: 10.1001/archderm.140.12.1453. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physicians global assessment
Primary	at week 12 or 24
Secondary	Response rate per treatment group
Secondary	Modified total lesion symptom score
Secondary	Patients global assessment
Secondary	at week 12 or 24
Secondary	Time to relapse