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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Efficacy and Safety of Oral Alitretinoin (Toctino®) in the Treatment of Patients With Cutaneous Lupus Erythematosus: A Multicentre, Open-Label, Prospective Pilot Stud

Brief 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").

Detailed Summary:
Sponsor: University Hospital Muenster

Current Primary Outcome: Primary efficacy outcome is the response rate at week 24 or at the latest assessment for patients who withdrew prematurely. [ Time Frame: Week 24 or at the latest assessment for patients who withdrew prematurely. ]

Response is defined as a reduction of 50% in the total RCLASI activity for skin lesions, compared to the baseline value ("RCLASI 50")


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Proportion of patients with RCLASI 50 at week 12 of treatment. [ Time Frame: Week 12 of treatment ]
  • Proportion of patients with at least partial response at end of therapy (with regard to RCLASI activity score for skin lesions). [ Time Frame: End of therapy (up to 24 weeks) ]
  • Patient's global assessment and VAS for itch and pain 12 weeks after the beginning of treatment. [ Time Frame: 12 weeks after the beginning of treatment ]
  • Number of Participants with Adverse Events (AEs) and their severity. [ Time Frame: 24 weeks of treatment + 5 weeks of follow up ]
  • Patient's global assessment and VAS for itch and pain at the end of therapy. [ Time Frame: End of therapy (up to 24 weeks) ]


Original Secondary Outcome:

  • Proportion of patients with RCLASI 50 at week 12 of treatment. [ Time Frame: Week 12 of treatment ]
  • Proportion of patients with at least partial response at end of therapy (with regard to RCLASI activity score for skin lesions). [ Time Frame: End of therapy (up to 24 weeks) ]
  • Patient's global assessment and VAS for itch and pain 12 weeks after the beginning of treatment and at the end of therapy. [ Time Frame: 12 weeks after the beginning of treatment and at the end of therapy (up to 24 weeks) ]
  • Number of Participants with Adverse Events (AEs) and their severity. [ Time Frame: 24 weeks of treatment + 5 weeks of follow up ]


Information By: University Hospital Muenster

Dates:
Date Received: August 1, 2011
Date Started: August 2011
Date Completion:
Last Updated: May 30, 2016
Last Verified: May 2016