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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Patients in arm one used twice daily pimecrolimus 1% cream on their facial discoid lupus erythematosus lesions for 8 weeks. |
|
| 2 | Active Comparator | Twice daily betamethasone valerate 0.1% cream to facial lesions of discoid lupus erythematosus for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pimecrolimus 1% cream | Drug | a very thin coat of pimecrolimus 1% cream, twice daily topically to the facial lesions of discoid lupus erythematosus |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy end points included a combined score based on evaluation of erythema, infiltration and squamation | 1st day, after 2, 4, 6 and 8 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary outcome: Safety assessments included monitoring of adverse events | 1st day, after 2, 4, 6 and 8 weeks of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Behrooz Barikbin, M.D. | Skin Research Center of Shahid Beheshti medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shohada'e Tajrish Hospital | Tehran | Tehran Province | 1989934148 | Iran |
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| betamethasone valerate 0.1% cream | Drug | A very thin coat of betamethasone valerate 0.1% cream, twice daily to facial lesions of discoid lupus erythematosus for 8 weeks. |
|
| ID | Term |
|---|---|
| D008179 | Lupus Erythematosus, Discoid |
| ID | Term |
|---|---|
| D008178 | Lupus Erythematosus, Cutaneous |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C117268 | pimecrolimus |
| D001624 | Betamethasone Valerate |
| ID | Term |
|---|---|
| D001623 | Betamethasone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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