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| Sponsored by: |
Shaheed Beheshti Medical University |
| Information provided by: | Shaheed Beheshti Medical University |
| ClinicalTrials.gov Identifier: | NCT00608673 |
Purpose
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.
| Condition | Intervention |
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Discoid Lupus Erythematosus |
Drug: Pimecrolimus 1% cream Drug: betamethasone valerate 0.1% cream |
| MedlinePlus related topics: | Lupus |
| Drug Information available for: | Betamethasone Bentelan Betamethasone dipropionate Pimecrolimus |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver), Parallel Assignment, Safety/Efficacy Study |
| 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. |
| Enrollment: | 10 |
| Study Start Date: | April 2006 |
| Study Completion Date: | November 2007 |
| Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
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1: Experimental
Patients in arm one used twice daily pimecrolimus 1% cream on their facial discoid lupus erythematosus lesions for 8 weeks.
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Drug: Pimecrolimus 1% cream
a very thin coat of pimecrolimus 1% cream, twice daily topically to the facial lesions of discoid lupus erythematosus
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2: Active Comparator
Twice daily betamethasone valerate 0.1% cream to facial lesions of discoid lupus erythematosus for 8 weeks
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Drug: betamethasone valerate 0.1% cream
A very thin coat of betamethasone valerate 0.1% cream, twice daily to facial lesions of discoid lupus erythematosus for 8 weeks.
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Eligibility
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Iran, Islamic Republic of | |||||
| Shohada'e Tajrish Hospital | |||||
| Tehran, Iran, Islamic Republic of, 1989934148 | |||||
| Shaheed Beheshti Medical University |
| Study Chair: | Behrooz Barikbin, M.D. | Skin Research Center of Shahid Beheshti medical University |
More Information
| Responsible Party: | Skin research centre, Shahid Beheshti University, M.C. ( Behrooz Barikbin, M.D. ) |
| Study ID Numbers: | 77 |
| First Received: | January 23, 2008 |
| Last Updated: | February 6, 2008 |
| ClinicalTrials.gov Identifier: | NCT00608673 |
| Health Authority: | Iran: Ministry of Health |
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