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

Discoid Lupus Erythematosus Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00608673
• Other study ID #: 77
• Status: Completed
• Phase: N/A
• First received: January 23, 2008
• Last updated: February 6, 2008
• Start date: April 2006
• Est. completion date: November 2007

Study information

• Verified date: January 2008
• Source: hahid Beheshti University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: November 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Discoid Lupus Erythematosus
• Lupus Erythematosus, Discoid
• Lupus Erythematosus, Systemic

Intervention

Drug:
• Pimecrolimus 1% cream
a very thin coat of pimecrolimus 1% cream, twice daily topically to the facial lesions of discoid lupus erythematosus
• 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.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Shohada'e Tajrish Hospital	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
hahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Secondary outcome: Safety assessments included monitoring of adverse events		1st day, after 2, 4, 6 and 8 weeks of treatment	Yes