Follow-up Efficacy and Safety of Alitretinoin in Severe Chronic Hand Dermatitis - Full Text View

Sponsored by:	Basilea Pharmaceutica
Information provided by:	Basilea Pharmaceutica
ClinicalTrials.gov Identifier:	NCT00124436

Purpose

Patients who have been treated in study protocol BAP089 may have responded to treatment, and subsequently relapsed to >75% of the baseline disease severity, will be investigated for response to further treatment with alitretinoin. Also, patients who have responded with mild or moderate disease will be investigated for additional treatment effect after prolongated treatment.

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:	Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Follow up Efficacy and Safety Study of BAL4979 in the Treatment of Chronic Hand Dermatitis Refractory to Topical Treatment

Further study details as provided by Basilea Pharmaceutica:

Primary Outcome Measures:

Response of chronic hand dermatitis to study treatment as assessed by Physicians Global Assessment, at week 12 or 24

Secondary Outcome Measures:

Patient's global assessment
Extent of disease
Time to respond
Modified total lesion symptom score
at week 12 or 24

Estimated Enrollment:	300
Study Start Date:	March 2005
Study Completion Date:	February 2007
Primary Completion Date:	January 2007 (Final data collection date for primary outcome measure)

Eligibility

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

Criteria

Inclusion Criteria:

Previous participation in protocol BAP089
Response of severe, treatment refractory hand dermatitis with mild or moderate, or responding patients who relapsed to 75% of baseline disease

Exclusion Criteria:

Female patients who are pregnant or who want to become pregnant
Female patients of child bearing potential who cannot use or who will not commit to using two effective methods of contraception

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00124436

Locations

Germany
Thomas Ruzicka
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:	BAP00091
Study First Received:	July 26, 2005
Last Updated:	January 17, 2008
ClinicalTrials.gov Identifier:	NCT00124436
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices; France: Afssaps - French Health Products Safety Agency; Netherlands: Medicines Evaluation Board (MEB); Denmark: Danish Medicines Agency; Sweden: Medical Products Agency; Finland: National Agency for Medicines; Czech Republic: State Institute for Drug Control; Hungary: National Institute of Pharmacy; Poland: Ministry of Health; Canada: Health Canada

Keywords provided by Basilea Pharmaceutica:

Patients who have been enrolled in study protocol BAP089, and whose severe chronic hand dermatitis responded with mild or moderate disease, or who relapsed

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