Comparing the Therapeutic Efficacy of Pimecrolimus Cream With Betamethasone Cream for Discoid Lupus Erythematosus
|ClinicalTrials.gov Identifier: NCT00608673|
Recruitment Status : Completed
First Posted : February 6, 2008
Last Update Posted : February 15, 2008
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 or disease||Intervention/treatment||Phase|
|Discoid Lupus Erythematosus||Drug: Pimecrolimus 1% cream Drug: betamethasone valerate 0.1% cream||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|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 Start Date :||April 2006|
|Actual Primary Completion Date :||July 2007|
|Actual Study Completion Date :||November 2007|
Patients in arm one used twice daily pimecrolimus 1% cream on their facial discoid lupus erythematosus lesions for 8 weeks.
Drug: Pimecrolimus 1% cream
a very thin coat of pimecrolimus 1% cream, twice daily topically to the facial lesions of discoid lupus erythematosus
Other Name: Elidel
Active Comparator: 2
Twice daily betamethasone valerate 0.1% cream to facial lesions of discoid lupus erythematosus for 8 weeks
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.
- 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: Safety assessments included monitoring of adverse events [ Time Frame: 1st day, after 2, 4, 6 and 8 weeks of treatment ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00608673
|Iran, Islamic Republic of|
|Shohada'e Tajrish Hospital|
|Tehran, Iran, Islamic Republic of, 1989934148|
|Study Chair:||Behrooz Barikbin, M.D.||Skin Research Center of Shahid Beheshti medical University|