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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00519675
Other study ID # BAP00731
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date May 2007

Study information

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

Clinical Trial Summary

The purpose of the study is to investigate the safety and efficacy of alitretinoin in chronic hand eczema that is refractory to topical corticosteroids.


Description:

Chronic hand eczema is a frequent and distressing disease. The course of the disease is of chronic-relapsing nature. In a phase III study alitretinoin was clinically effective for patients with severe chronic hand eczema refractory to topical treatment. This study investigates the safety and efficacy of alitretinoin who previously have participated in a clinical trial involving alitretinoin.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Previous participation in therapeutic trials involving chronic hand eczema - Relapse of chronic hand eczema, defined as 75% of the baseline initial total lesion symptom score Exclusion Criteria: - Patients whose disease is adequately controlled by standard non-medicated skin care and topical corticosteroid therapy

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
alitretinoin


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Basilea Pharmaceutica

Countries where clinical trial is conducted

France,  Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety assessments
Secondary Efficacy (Physicians Global Assessment)
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