Efficacy and Safety of a Retinoid for the Treatment of Severe Chronic Hand Dermatitis - Full Text View

Sponsored by:	Basilea Pharmaceutica
Information provided by:	Basilea Pharmaceutica
ClinicalTrials.gov Identifier:	NCT00124475

Purpose

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

Condition	Intervention	Phase
Hand Dermatoses	Drug: alitretinoin	Phase III

MedlinePlus related topics: Skin Conditions

Drug Information available for: 9-cis-Retinoic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Efficacy and Safety of BAL4079 in the Treatment of Severe Refractory Chronic Hand Dermatitis

Further study details as provided by Basilea Pharmaceutica:

Primary Outcome Measures:

Physicians global assessment
at week 12 or 24

Secondary Outcome Measures:

Response rate per treatment group
Modified total lesion symptom score
Patients global assessment
at week 12 or 24
Time to relapse

Estimated Enrollment:	1035
Study Start Date:	December 2004
Study Completion Date:	September 2007
Primary Completion Date:	October 2006 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00124475

Locations

Germany
Thomas Ruzicka, MD
Düsseldorf, Germany, 40225

Sponsors and Collaborators

Basilea Pharmaceutica

Investigators

Principal Investigator:

Thomas Ruzicka, MD

University of Düsseldorf, Dermatological Hospital, Germany

More Information

Publications:

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.

Study ID Numbers:	BAP00089
Study First Received:	July 26, 2005
Last Updated:	January 17, 2008
ClinicalTrials.gov Identifier:	NCT00124475
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices; Finland: National Agency for Medicines; France: Afssaps - French Health Products Safety Agency; Denmark: Danish Medicines Agency; Poland: Ministry of Health; Hungary: National Institute of Pharmacy; Sweden: Medical Products Agency; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Netherlands: Medicines Evaluation Board (MEB); Czech Republic: State Institute for Drug Control; Canada: Health Canada

Keywords provided by Basilea Pharmaceutica:

Chronic Hand Dermatitis

Study placed in the following topic categories:

Hand Dermatoses
Alitretinoin
Skin Diseases
Skin Abnormalities

Acrodermatitis
Congenital Abnormalities
Dermatitis

Additional relevant MeSH terms:

Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009