Clinical Trial: Cutaneous Lupus Erythematosus and Elidel
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Evaluation of the Therapeutic Effect and Local Tolerability of Elidel® Cream 1% (Pimecrolimus) in Chronic Discoid Lupus Erythematosus (dLE) or Subacute Cutaneous Lupus Eryth
Brief Summary: This trial evaluates the therapeutic effect of Elidel (pimecrolimus) in comparison to the corresponding vehicle in patients with chronic discoid lupus erythematosus (dLE) or subacute cutaneous lupus erythematosus (scLE).
Detailed Summary:
Lupus erythematosus is an autoimmune disease of unknown origin which is classified according to its clinical features, the course, and laboratory findings. A rough classification divides lupus erythematosus into three subgroups:
- discoid lupus erythematosus (dLE),
- subacute cutaneous lupus erythematosus (scLE), and
- systemic lupus erythematosus (sLEsLE).
The onset of lupus erythematosus affects women three times more frequently than men, with an onset between the 20th and 40th years of life. It is often aggravated or triggered by multiple factors like UV-light, mainly UV-A, hormones (thyroid diseases), pregnancy, oral contraceptives, stress or trauma. Some medications might also play a role as triggering substances, for example antibiotics, psychotropic drugs, beta blockers, procainamide, diuretics, piroxicam, and griseofulvin.
The prevalence of systemic lupus erythematosus (sLEsLE) is 12 to 50/100.000 population worldwide, the incidence is 2 to 8/100.000 per year. Skin disease is one of the most frequent clinical complaints of patients suffering from sLEsLE. It has been found to occur in up to 70% of patients during the course of the disease.
The interesting subgroups of LE that are part of the study population suffer from discoid lupus erythematosus (dLE) or subacute cutaneous lupus erythematosus (scLE) (Fritsch, 1998).
Discoid lupus erythematosus is the most common form of the chronic forms of cutaneous LE. It is a very chronic inflammatory disease consisting of fixed, indurated, erythematous papules and plaques that are often distributed on the head and neck. Without
Sponsor: University of Leipzig
Current Primary Outcome: therapeutic effect
Original Primary Outcome: Same as current
Current Secondary Outcome: local tolerability
Original Secondary Outcome: Same as current
Information By: University of Leipzig
Dates:
Date Received: September 19, 2005
Date Started: June 2003
Date Completion:
Last Updated: April 5, 2007
Last Verified: February 2007
