TerminatedPhase 2

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

Germany7 participantsStarted 2011-08

Plain-language 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").

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. Fasting triglyceridemia \> 1.5 x upper limit of normal (ULN)
. Fasting total cholesterol \> 1.5 x ULN
. Fasting low-density lipoprotein (LDL) cholesterol \> 1.5x ULN

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial was terminated before it completed — do you know why it was stopped early, and does that affect whether alitretinoin is still considered a viable option for my cutaneous lupus?
2Since this was a Phase 2 trial that didn't finish, how much do we actually know about whether alitretinoin is safe and effective for cutaneous lupus, and are there any completed studies I should be aware of?
3Alitretinoin is already approved for a different skin condition — does that existing safety data give us any useful information about its risks for someone with cutaneous lupus like mine?
4Given that this trial measured response at 24 weeks and was terminated early, are there standard or better-established treatments for my type of cutaneous lupus that we should try before considering something experimental like this?
5Are there any currently active or recruiting trials for cutaneous lupus that might be worth discussing as an alternative, now that this particular study is no longer enrolling?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Primary efficacy outcome is the response rate at week 24 or at the latest assessment for patients who withdrew prematurely.

Timeframe: Week 24 or at the latest assessment for patients who withdrew prematurely.

Trial details

NCT IDNCT01407679

SponsorUniversity Hospital Muenster

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-04

View on ClinicalTrials.gov More Lupus Erythematosus, Cutaneous trials