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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00608673

Enrollment

Registered

2008-02-06

Start date

2006-04-30

Completion date

2007-11-30

Last updated

2008-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Discoid Lupus Erythematosus

Keywords

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

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.

Interventions

DRUGPimecrolimus 1% cream

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

DRUGbetamethasone 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

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

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026