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

Hand Dermatoses Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00309621
• Other study ID #: BAP00626
• Status: Completed
• Phase: Phase 3
• Start date: April 2006
• Est. completion date: May 2007

Study information

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

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: May 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Dermatitis
• Hand Dermatoses
• Skin Diseases

Intervention

Drug:
• alitretinoin

Locations

Country	Name	City	State
Germany	Abt. Klinische Sozialmedizin	Heidelberg

Sponsors (1)

Lead Sponsor	Collaborator
Basilea Pharmaceutica

Countries where clinical trial is conducted

Canada,  Germany,  Poland, 

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	Safety:
Primary	Adverse Events
Primary	Safety Laboratory
Primary	Radiological investigations (bone density, x-ray)
Secondary	Physicians Global Assessment
Secondary	modified Total Lesion Symptom Score
Secondary	Patients Global Assessment
Secondary	Patient Defined Outcomes