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Efficacy and Safety of Oral Alitretinoin (Toctino®) in the Treatment of Patients With Cutaneous Lupus Erythematosus

NCT01407679 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2016-06-01

No results posted yet for this study

Summary

To evaluate the therapeutic effect of oral alitretinoin (Toctino®) in the treatment of CLE with respect to proportion of responders based on the Revised Cutaneous Lupus Disease Area and Severity Index (RCLASI) activity score for skin lesions at baseline and after 24 weeks of treatment or at the latest assessment for patients who withdrew prematurely. Response is defined as a reduction of 50% in the total RCLASI compared to the baseline value ("RCLASI 50").

Conditions

  • Lupus Erythematosus, Cutaneous

Interventions

DRUG

Alitretinoin

1 capsule Alitretinoin 30 mg per day; optional reduction to 10 mg per day in case unacceptable adverse reactions to the higher dose occur

Sponsors & Collaborators

  • Basilea Pharmaceutica International Ltd

    collaborator INDUSTRY

  • University Hospital Muenster

    lead OTHER

Principal Investigators

  • Annegret Kuhn, Prof. Dr. · Department of Dermatology, University Hospital Muenster, Muenster, Germany

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2014-04-30
Completion
2014-04-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01407679 on ClinicalTrials.gov