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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00608673
Recruitment Status : Completed
First Posted : February 6, 2008
Last Update Posted : February 15, 2008
Sponsor:
Information provided by:

Study Description
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.


Condition or disease Intervention/treatment
Discoid Lupus Erythematosus Drug: Pimecrolimus 1% cream Drug: betamethasone valerate 0.1% cream

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
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.
Study Start Date : April 2006
Primary Completion Date : July 2007
Study Completion Date : November 2007


Arms and Interventions

Arm Intervention/treatment
Experimental: 1
Patients in arm one used twice daily pimecrolimus 1% cream on their facial discoid lupus erythematosus lesions for 8 weeks.
Drug: Pimecrolimus 1% cream
a very thin coat of pimecrolimus 1% cream, twice daily topically to the facial lesions of discoid lupus erythematosus
Other Name: Elidel
Active Comparator: 2
Twice daily betamethasone valerate 0.1% cream to facial lesions of discoid lupus erythematosus for 8 weeks
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.


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  1. Secondary outcome: Safety assessments included monitoring of adverse events [ Time Frame: 1st day, after 2, 4, 6 and 8 weeks of treatment ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00608673


Locations
Iran, Islamic Republic of
Shohada'e Tajrish Hospital
Tehran, Iran, Islamic Republic of, 1989934148
Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences
Investigators
Study Chair: Behrooz Barikbin, M.D. Skin Research Center of Shahid Beheshti medical University
More Information

Responsible Party: Behrooz Barikbin, M.D., Skin research centre, Shahid Beheshti University, M.C.
ClinicalTrials.gov Identifier: NCT00608673     History of Changes
Other Study ID Numbers: 77
First Posted: February 6, 2008    Key Record Dates
Last Update Posted: February 15, 2008
Last Verified: January 2008

Keywords provided by Shahid Beheshti University of Medical Sciences:
discoid lupus erythematosus
pimecrolimus 1% cream
betamethasone valerate 0.1% cream

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Lupus Erythematosus, Discoid
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Lupus Erythematosus, Cutaneous
Skin Diseases
Betamethasone benzoate
Betamethasone-17,21-dipropionate
Pimecrolimus
Betamethasone
Betamethasone Valerate
Betamethasone sodium phosphate
Tacrolimus
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antirheumatic Agents
Dermatologic Agents
Immunosuppressive Agents
Immunologic Factors