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

Phase 3

Completed

• Conditions: Hand Dermatoses

• Registration Number: NCT00124436
• Lead Sponsor: Basilea Pharmaceutica

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 Description

Not available

Study Timeline

• Study Start: 2005-03
• Study First Submitted: 2005-07-26
• Study First Submitted QC: 2005-07-27
• Study First Posted: 2005-07-28
• Primary Completion: 2007-01
• Study Completion: 2007-02
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-09
• Last Update Posted: 2023-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Thomas Ruzicka; 🇩🇪 Düsseldorf, Germany