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

Sponsor

Shahid Beheshti University of Medical Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT00608673

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Discoid Lupus Erythematosus	Drug: Pimecrolimus 1% cream Drug: betamethasone valerate 0.1% cream	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Treatment

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 :

Apr 1, 2006

Actual Primary Completion Date :

Jul 1, 2007

Actual Study Completion Date :

Nov 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 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 Names: 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.

Arm

Intervention/Treatment

Experimental: 1

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 Names:

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.

Outcome Measures

Primary Outcome Measures

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]