Back to resultsComparing the Therapeutic Efficacy of Pimecrolimus Cream With Betamethasone Cream for Discoid Lupus Erythematosus
Primary Purpose
Discoid Lupus Erythematosus
Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Pimecrolimus 1% cream
betamethasone valerate 0.1% cream
Sponsored by
About this trial
This is an interventional treatment trial for Discoid Lupus Erythematosus focused on measuring discoid lupus erythematosus, pimecrolimus 1% cream, betamethasone valerate 0.1% cream
Eligibility 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
Sites / Locations
- Shohada'e Tajrish Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Patients in arm one used twice daily pimecrolimus 1% cream on their facial discoid lupus erythematosus lesions for 8 weeks.
Twice daily betamethasone valerate 0.1% cream to facial lesions of discoid lupus erythematosus for 8 weeks
Outcomes
Primary Outcome Measures
Efficacy end points included a combined score based on evaluation of erythema, infiltration and squamation
Secondary Outcome Measures
Secondary outcome: Safety assessments included monitoring of adverse events
Full Information
NCT ID
NCT00608673
First Posted
January 23, 2008
Last Updated
February 6, 2008
Sponsor
Shahid Beheshti University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT00608673
Brief Title
Comparing the Therapeutic Efficacy of Pimecrolimus Cream With Betamethasone Cream for Discoid Lupus Erythematosus
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 Type
Interventional
2. Study Status
Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
November 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Shahid Beheshti University of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Discoid Lupus Erythematosus
Keywords
discoid lupus erythematosus, pimecrolimus 1% cream, betamethasone valerate 0.1% cream
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Patients in arm one used twice daily pimecrolimus 1% cream on their facial discoid lupus erythematosus lesions for 8 weeks.
Arm Title
2
Arm Type
Active Comparator
Arm Description
Twice daily betamethasone valerate 0.1% cream to facial lesions of discoid lupus erythematosus for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Pimecrolimus 1% cream
Other Intervention Name(s)
Elidel
Intervention Description
a very thin coat of pimecrolimus 1% cream, twice daily topically to the facial lesions of discoid lupus erythematosus
Intervention Type
Drug
Intervention Name(s)
betamethasone valerate 0.1% cream
Intervention Description
A very thin coat of betamethasone valerate 0.1% cream, twice daily to facial lesions of discoid lupus erythematosus for 8 weeks.
Primary Outcome Measure Information:
Title
Efficacy end points included a combined score based on evaluation of erythema, infiltration and squamation
Time Frame
1st day, after 2, 4, 6 and 8 weeks of treatment
Secondary Outcome Measure Information:
Title
Secondary outcome: Safety assessments included monitoring of adverse events
Time Frame
1st day, after 2, 4, 6 and 8 weeks of treatment
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Behrooz Barikbin, M.D.
Organizational Affiliation
Skin Research Center of Shahid Beheshti medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Shohada'e Tajrish Hospital
City
Tehran
ZIP/Postal Code
1989934148
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Learn more about this trial
Comparing the Therapeutic Efficacy of Pimecrolimus Cream With Betamethasone Cream for Discoid Lupus Erythematosus
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