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

NCT ID: NCT00309621

Last Updated: 2023-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2007-05-31

Brief Summary

Patients with severe chronic hand dermatitis, that has not responded to topical treatment, including topical steroids and the avoidance of aggravating factors, will be treated with the oral medication alitretinoin. The study aims to investigate the safety and efficacy of the medication when given over a period of 6 months.

Detailed Description

For severe, chronic hand dermatitis, refractory to topical treatment and the avoidance of aggravating factors such as allergens and irritants, no registered systemic treatment is available. Current systemic treatment options consist in the off-label use of systemic immune suppressants, such as cyclosporine, methotrexate.

Severe chronic hand dermatitis is a debilitating disease, with massive impact on social life and working ability. A huge proportion of the population suffers for more than a decade, and job losses are a frequent consequence.

This open-label trial investigates the safety and efficacy of oral alitretinoin 30mg as a single daily dose for up to 6 months. The trial is complementary to the pivotal efficacy study BAP00089.

Conditions

Hand Dermatoses

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

alitretinoin

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Chronic hand dermatitis, rated as severe by physicians global assessment, present for at least 6 months, that has not responded to the avoidance of allergens and irritants and the use of topical steroids

Exclusion Criteria

• female of childbearing potential, unless participating in a pregnancy prevention program
• psoriasis
• active major psychiatric condition

• 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 Diepgen, MD

Role: PRINCIPAL_INVESTIGATOR

Univ. Heidelberg

Locations

Edmonton, Alberta, Canada

Vancouver, British Columbia, Canada

Winnipeg, Manitoba, Canada

Hawkesbury, Ontario, Canada

London, Ontario, Canada

Markham, Ontario, Canada

Oakville, Ontario, Canada

Montreal, Quebec, Canada

Sheerbroke, Quebec, Canada

Québec, , Canada

Berlin, , Germany

Berlin, , Germany

Cologne, , Germany

Frankfurt, , Germany

Hamburg, , Germany

Hamburg, , Germany

Hamburg, , Germany

Abt. Klinische Sozialmedizin

Heidelberg, , Germany

Ibbenbueren, , Germany

Lübeck, , Germany

Mönchengladbach, , Germany

München, , Germany

Münster, , Germany

Osnabrück, , Germany

Potsdam, , Germany

Viersen, , Germany

Wuppertal, , Germany

Gdansk, , Poland

Krakow, , Poland

Lublin, , Poland

Opole, , Poland

Szcecin, , Poland

Wroclaw, , Poland

Countries

Canada; Germany; Poland

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)

Blome C, Maares J, Diepgen T, Jeffrustenbach S, Augustin M. Measurement of patient-relevant benefits in the treatment of chronic hand eczema--a novel approach. Contact Dermatitis. 2009 Jul;61(1):39-45. doi: 10.1111/j.1600-0536.2009.01536.x.

Reference Type: DERIVED

PMID: 19659963 (View on PubMed)

Other Identifiers

BAP00626

Identifier Type: -

Identifier Source: org_study_id