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

Hand Dermatoses Clinical Trial

Official title:

Follow up Efficacy and Safety Study of BAL4979 in the Treatment of Chronic Hand Dermatitis Refractory to Topical Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00124436
• Other study ID #: BAP00091
• Status: Completed
• Phase: Phase 3
• Start date: March 2005
• Est. completion date: February 2007

Study information

• Verified date: May 2023
• Source: Basilea Pharmaceutica
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: February 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Dermatitis
• Hand Dermatoses
• Skin Diseases

Intervention

Drug:
• alitretinoin

Locations

Country	Name	City	State
Germany	Thomas Ruzicka	Düsseldorf

Sponsors (1)

Lead Sponsor	Collaborator
Basilea Pharmaceutica

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response of chronic hand dermatitis to study treatment as assessed by Physicians Global Assessment, at week 12 or 24
Secondary	Patient's global assessment
Secondary	Extent of disease
Secondary	Time to respond
Secondary	Modified total lesion symptom score
Secondary	at week 12 or 24