Clinical Trial: Follow-up Efficacy and Safety of Alitretinoin in Severe Chronic Hand Dermatitis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Follow up Efficacy and Safety Study of BAL4979 in the Treatment of Chronic Hand Dermatitis Refractory to Topical Treatment
Brief Summary: 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.
Detailed Summary:
Sponsor: Basilea Pharmaceutica
Current Primary Outcome: Response of chronic hand dermatitis to study treatment as assessed by Physicians Global Assessment, at week 12 or 24
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Patient's global assessment
- Extent of disease
- Time to respond
- Modified total lesion symptom score
- at week 12 or 24
Original Secondary Outcome:
- Patient's global assessment
- Extend of disease
- Time to respond
- Modified total lesion symptom score
- at week 12 or 24
Information By: Basilea Pharmaceutica
Dates:
Date Received: July 26, 2005
Date Started: March 2005
Date Completion:
Last Updated: July 16, 2010
Last Verified: July 2010