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

NCT00608673 | Completed DMC

• 1 other identifier: 77
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Discoid Lupus Erythematosus

Keywords

discoid lupus erythematosus; pimecrolimus 1% cream; betamethasone valerate 0.1% cream

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Secondary outcome: Safety assessments included monitoring of adverse events

  1st day, after 2, 4, 6 and 8 weeks of treatment

Study Arms (2)

1

EXPERIMENTAL

Patients in arm one used twice daily pimecrolimus 1% cream on their facial discoid lupus erythematosus lesions for 8 weeks.

Drug: Pimecrolimus 1% cream

2

ACTIVE COMPARATOR

Twice daily betamethasone valerate 0.1% cream to facial lesions of discoid lupus erythematosus for 8 weeks

Drug: betamethasone valerate 0.1% cream

Interventions

Pimecrolimus 1% cream DRUG

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

Also known as: Elidel

1

betamethasone valerate 0.1% cream DRUG

A very thin coat of betamethasone valerate 0.1% cream, twice daily to facial lesions of discoid lupus erythematosus for 8 weeks.

2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients harboring discoid lupus erythematosus lesions on their face or neck

You may not qualify if:

• Patients with discoid lupus erythematosus in the setting of systemic lupus erythematosus
• Patients having a more disseminated disease

Sponsors & Collaborators

• Shahid Beheshti University of Medical Sciences: lead

Study Sites (1)

Shohada'e Tajrish Hospital

Tehran, Tehran Province, 1989934148, Iran

Location

MeSH Terms

Conditions

Lupus Erythematosus, Discoid

Interventions

pimecrolimus; Betamethasone Valerate

Condition Hierarchy (Ancestors)

Lupus Erythematosus, Cutaneous; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Intervention Hierarchy (Ancestors)

Betamethasone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Behrooz Barikbin, M.D.

  Skin Research Center of Shahid Beheshti medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 23, 2008
• First Posted: February 6, 2008
• Study Start: April 1, 2006
• Primary Completion: July 1, 2007
• Study Completion: November 1, 2007
• Last Updated: February 15, 2008

Record last verified: 2008-01

Locations

IR (1)