Comparing the Therapeutic Efficacy of Pimecrolimus Cream With Betamethasone Cream for Discoid Lupus Erythematosus
Information source: Shaheed Beheshti Medical University
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Discoid Lupus Erythematosus
Intervention: Pimecrolimus 1% cream (Drug); betamethasone valerate 0.1% cream (Drug)
Phase: N/A
Status: Completed
Sponsored by: Shaheed Beheshti Medical University Official(s) and/or principal investigator(s):
Behrooz Barikbin, M.D., Study Chair, Affiliation: Skin Research Center of Shahid Beheshti medical University
Summary
Discoid lupus erythematosus lesions are commonly treated with corticosteroids, but
corticosteroids may induce side effects such as thinning of the skin or scarring. Therefore,
an alternative medication with the same efficacy, but without the side-effects is sought
after.
Pimecrolimus is a newer drug specially designed to treat inflammatory diseases of skin. Its
efficacy in treating discoid lupus erythematosus has not been studied extensively yet.
However studies performed till now show promising results. Long-term topical use of this
medication has not shown any serious side-effects in other skin diseases.
In this study we aimed at comparing pimecrolimus efficacy with that of a common therapeutic
choice, betamethasone valerate 0. 1% cream, to see if pimecrolimus can be used as an
alternative medication in treating discoid lupus erythematosus.
Clinical Details
Official title: Pimecrolimus 1% Cream vs. Betamethasone Valerate 0.1% Cream in the Treatment of Facial Discoid Lupus Erythematosus: a Double-Blind Randomized, Pilot Study.
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver), Parallel Assignment, Safety/Efficacy Study
Primary outcome: Efficacy end points included a combined score based on evaluation of erythema, infiltration and squamation
Secondary outcome: Secondary outcome: Safety assessments included monitoring of adverse events
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients harboring discoid lupus erythematosus lesions on their face or neck
Exclusion Criteria:
- Patients with discoid lupus erythematosus in the setting of systemic lupus
erythematosus
- Patients having a more disseminated disease
Locations and Contacts
Shohada'e Tajrish Hospital, Tehran 1989934148, Iran, Islamic Republic of
Additional Information
Starting date: April 2006
Ending date: November 2007
Last updated: February 6, 2008
|
