Comparing the Therapeutic Efficacy of Pimecrolimus Cream With Betamethasone Cream for Discoid Lupus Erythematosus

Study Overview
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Brief Summary
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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.

Official Title
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Pimecrolimus 1% Cream vs. Betamethasone Valerate 0.1% Cream in the Treatment of Facial Discoid Lupus Erythematosus: a Double-Blind Randomized, Pilot Study.

Conditions
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Discoid Lupus Erythematosus

Intervention / Treatment
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* Drug: Pimecrolimus 1% cream
* Drug: betamethasone valerate 0.1% cream


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Patients in arm one used twice daily pimecrolimus 1% cream on their facial discoid lupus erythematosus lesions for 8 weeks. | Drug: Pimecrolimus 1% cream<br>* a very thin coat of pimecrolimus 1% cream, twice daily topically to the facial lesions of discoid lupus erythematosus<br>* Other names: Elidel;|
| Active Comparator: 2<br>Twice daily betamethasone valerate 0.1% cream to facial lesions of discoid lupus erythematosus for 8 weeks | Drug: betamethasone valerate 0.1% cream<br>* A very thin coat of betamethasone valerate 0.1% cream, twice daily to facial lesions of discoid lupus erythematosus for 8 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary outcome: Safety assessments included monitoring of adverse events |  | 1st day, after 2, 4, 6 and 8 weeks of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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discoid lupus erythematosus, pimecrolimus 1% cream, betamethasone valerate 0.1% cream