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

This study has been completed.
Sponsor:
Information provided by:
Shaheed Beheshti Medical University
ClinicalTrials.gov Identifier:
NCT00608673
First received: January 23, 2008
Last updated: February 6, 2008
Last verified: January 2008
History of Changes
  Purpose

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 Intervention
Discoid Lupus Erythematosus
 Drug: Pimecrolimus 1% cream
Drug: betamethasone valerate 0.1% cream

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Shaheed Beheshti Medical University:

Primary Outcome 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Secondary outcome: Safety assessments included monitoring of adverse events [ Time Frame: 1st day, after 2, 4, 6 and 8 weeks of treatment ] [ Designated as safety issue: Yes ]

Enrollment: 10
Study Start Date: April 2006
Study Completion Date: November 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00608673

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

No publications provided

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
Study First Received: January 23, 2008
Last Updated: February 6, 2008
Health Authority: Iran: Ministry of Health

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

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

ClinicalTrials.gov processed this record on May 23, 2013