Lupus Erythematosus, Cutaneous Clinical Trial
Official title:
Efficacy and Safety of Fumaric Acid Esters (Fumaderm®) in the Treatment of Patients With Cutaneous Lupus Erythematosus: A Mono-Centre, Open-Label, Prospective Pilot Study
The purpose of this study is to evaluate the therapeutic effect of fumaric acid esters (Fumaderm®) in the treatment of Cutaneous Lupus Erythematosus 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 (Last Observation Carried Forward, LOCF).
At screening, patients meeting the inclusion and exclusion criteria will be asked to provide
written informed consent. Male patients and female patients without childbearing potential
will also complete other screening procedures including vital signs, physical examination,
and patients and physicians efficacy assessments.
Treatment will be started as soon as possible after screening and not later than 1 month
after screening.
The patients will receive a treatment either with Fumaderm® initial and/or Fumaderm®
enteric-coated tablets. Fumaderm® initial will be usually administered during the first
three weeks of treatment and / or during the trial when adaptation of the daily dosage will
be required due to the occurrence of adverse reactions, e.g gastrointestinal.
Throughout the trial, daily use of sunscreens (sun protection factor, SPF≥50) will be
recommended to all patients. The management of CLE may also involve the use of topical
medications, such as topical steroids, or systemic rescue medications, such as
antimalarials.
All patients will be evaluated with the RCLASI, PAGI and VAS after 12 weeks and at the end
of treatment. Adverse Events (AE) will be recorded at each visit until 4 weeks after the end
of therapy. Serious Adverse Events (SAE) must be reported if they occur up to 4 weeks after
the end of therapy.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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