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Follow-Up Efficacy and Safety of Alitretinoin in Severe Chronic Hand Dermatitis - Article


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Clinical Trial: Follow-Up Efficacy and Safety of Alitretinoin in Severe Chronic Hand Dermatitis

This study is currently recruiting patients.
Verified by Basilea Pharmaceutica July 2005

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

MedlinePlus consumer health information 

Study Type: Interventional
Study Design: Educational/Counseling/Training, 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: 
Primary Outcomes: Response of Chronic Hand Dermatitis to study treatment as assessed by Physicians Global Assessment, at week 12 or 24
Secondary Outcomes: Patient''''s global assessment; Extend of disease; Time to respond; Modified total lesion symptom score; at week 12 or 24
Expected Total Enrollment:  300

Study start: March 2005

Eligibility

Ages Eligible for Study:  18 Years   -   75 Years,  Genders Eligible for Study:  Both
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

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00124436

Jürgen Maares, MD      +41 616061-111  Ext. 229    juergen.maares@basilea.com

Germany
      Thomas Ruzicka, Düsseldorf,  40225,  Germany; Recruiting

Study chairs or principal investigators

Thomas Ruzicka, MD,  Principal Investigator,  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:  BAP091
Last Updated:  August 1, 2005
Record first received:  July 27, 2005
ClinicalTrials.gov Identifier:  NCT00124436
Health Authority: Germany: Federal Institute for Drugs and Medicinal 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
ClinicalTrials.gov processed this record on 2005-08-02


Source: ClinicalTrials.gov
Cache Date: August 3, 2005


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