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

Not Applicable

Completed

• Conditions: Discoid Lupus Erythematosus
• Interventions: Drug: betamethasone valerate 0.1% cream; Drug: Pimecrolimus 1% cream

• Registration Number: NCT00608673
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04
• Primary Completion: 2007-07
• Study Completion: 2007-11
• Status Verified: 2008-01
• Study First Submitted: 2008-01-23
• Study First Submitted QC: 2008-01-23
• Study First Posted: 2008-02-06
• Last Update Submitted: 2008-02-06
• Last Update Posted: 2008-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	betamethasone valerate 0.1% cream	Twice daily betamethasone valerate 0.1% cream to facial lesions of discoid lupus erythematosus for 8 weeks
1	Pimecrolimus 1% cream	Patients in arm one used twice daily pimecrolimus 1% cream on their facial discoid lupus erythematosus lesions for 8 weeks.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Secondary outcome: Safety assessments included monitoring of adverse events	1st day, after 2, 4, 6 and 8 weeks of treatment

Trial Locations

Locations (1)

Shohada'e Tajrish Hospital; 🇮🇷 Tehran, Iran, Islamic Republic of