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Completed

NCT Number: NCT00608673

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

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shohada'e Tajrish Hospital

Tehran, Tehran Province, 1989934148, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pimecrolimus 1% cream

Drug

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

Other names: Elidel

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Secondary outcome: Safety assessments included monitoring of adverse events

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

Sponsors and collaborators

Lead sponsor

Shahid Beheshti University of Medical Sciences

Other

Registry information

Official study title

Pimecrolimus 1% Cream vs. Betamethasone Valerate 0.1% Cream in the Treatment of Facial Discoid Lupus Erythematosus: a Double-Blind Randomized, Pilot Study.

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Feb 6, 2008
Registry last updated
Feb 15, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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