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.”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver), Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: July 2007

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Patients in arm one used twice daily pimecrolimus 1% cream on their facial discoid lupus erythematosus lesions for 8 weeks.
• Active Comparator: 2
  • Twice daily betamethasone valerate 0.1% cream to facial lesions of discoid lupus erythematosus for 8 weeks

Primary Measures

• 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
    Safety Issue?: Yes

Secondary Measures

• Secondary outcome: Safety assessments included monitoring of adverse events
  • Time Frame: 1st day, after 2, 4, 6 and 8 weeks of treatment
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Shaheed Beheshti Medical University

Overall Clinical Trial Officials and Contacts

Behrooz Barikbin, M.D. Study Chair Skin Research Center of Shahid Beheshti medical University  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00608673

Study ID Number: 77

ClinicalTrials.gov Identifier: NCT00608673

Health Authority: Iran: Ministry of Health