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Alitretinoin in the Treatment of Chronic Hand Eczema

Basilea Pharmaceutica logo

Basilea Pharmaceutica

Status and phase

Completed
Phase 3

Conditions

Eczema

Treatments

Drug: alitretinoin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00519675
BAP00731

Details and patient eligibility

About

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

Full 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.

Enrollment

150 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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