Clinical trial NCT00309621: Safety and Efficacy of a Retinoid for the Treatment of Severe Chronic Hand Dermatitis
Official title: Safety and Efficacy of Alitretinoin in the Treatment of Severe Refractory Chronic Hand Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hand Dermatoses
Keywords: Hand Dermatoses,
hand dermatitis
hand eczema
chronic hand dermatitis
retinoid
Lead sponsor: Basilea Pharmaceutica
Sponsor class: INDUSTRY
First posted: 2006-04-03
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Safety:
measure: Adverse Events
measure: Safety Laboratory
measure: Radiological investigations (bone density, x-ray)
Secondary outcomes:
measure: Physicians Global Assessment
measure: modified Total Lesion Symptom Score
measure: Patients Global Assessment
measure: Patient Defined Outcomes
Other outcomes:
Locations:
city: Edmonton
country: Canada
state: Alberta
city: Vancouver
country: Canada
state: British Columbia
city: Winnipeg
country: Canada
state: Manitoba
city: Hawkesbury
country: Canada
state: Ontario
city: London
country: Canada
state: Ontario
city: Markham
country: Canada
state: Ontario
city: Oakville
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Sheerbroke
country: Canada
state: Quebec
city: Quebec
country: Canada
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Frankfurt
country: Germany
city: Hamburg
country: Germany
city: Hamburg
country: Germany
city: Hamburg
country: Germany
city: Heidelberg
country: Germany
facility: Abt. Klinische Sozialmedizin
city: Ibbenbüren
country: Germany
city: Köln
country: Germany
city: Lübeck
country: Germany
city: Mönchengladbach
country: Germany
city: München
country: Germany
city: Münster
country: Germany
city: Osnabrück
country: Germany
city: Potsdam
country: Germany
city: Viersen
country: Germany
city: Wuppertal
country: Germany
city: Gdansk
country: Poland
city: Krakow
country: Poland
city: Lublin
country: Poland
city: Opole
country: Poland
city: Szcecin
country: Poland
city: Wroclaw
country: Poland
Study officials:
affiliation: Univ. Heidelberg
name: Thomas Diepgen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.