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

NCT ID: NCT00124475

Last Updated: 2023-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1035 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-12-31
• Study Completion Date: 2007-09-30

Brief Summary

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

Detailed 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.

Conditions

Hand Dermatoses

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

alitretinoin

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Basilea Pharmaceutica

INDUSTRY

Sponsor Role: lead

Principal Investigators

Thomas Ruzicka, MD

Role: PRINCIPAL_INVESTIGATOR

University of Düsseldorf, Dermatological Hospital, Germany

Locations

Thomas Ruzicka, MD

Düsseldorf, , Germany

Countries

Germany

References

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.

Reference Type: BACKGROUND

PMID: 15611422 (View on PubMed)

Other Identifiers

BAP00089

Identifier Type: -

Identifier Source: org_study_id