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A Randomized Clinical Trial of the Effect of Pimecrolimus Cream 1% Compared With Topical Corticosteroid in Treatment of Erosive Oral Lichen Planus

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
ATESSA PAKFETRAT, Mashhad University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01524744
First received: January 31, 2012
Last updated: February 1, 2012
Last verified: January 2012
History of Changes
  Purpose

The purpose of this study is to compare the effect of topical Pimecrolimus with adcortyl on erosive-atrophic 0ral lichen planus in a randomized clinical trial study.


Condition Intervention Phase
Oral Lichen Planus
 Drug: Pimecrolimus ointment
Drug: Adcortyl
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mashhad University of Medical Sciences:

Primary Outcome Measures:
  • signs of oral lichen planus [ Time Frame: every 2 weeks ] [ Designated as safety issue: Yes ]
    size and type of oral lichen planus has been recorded


Secondary Outcome Measures:
  • symptoms of oral lichen planus [ Time Frame: every 2 weeks ] [ Designated as safety issue: Yes ]
    pain of oral lesions has been recorded


Estimated Enrollment: 40
Study Start Date: March 2009
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Pimecrolimus ointment 0.1 %
This group used drugs 3 times a day for 2 months and then didn't eat or drink for 20 minutes after use
 Drug: Pimecrolimus ointment
Case group used drugs 3 times a day for 2 months and then didn't eat or drink for 20 minutes after use
Drug: Adcortyl
triamcinolone acetonide 0.1% in orabase
Active Comparator: Adcortyle
Control group used adcortyle (triamcinolone acetonide 0.1% in orabase, Bristol-Myers Squibbb, Anagn, Italy)
 Drug: Adcortyl
triamcinolone acetonide 0.1% in orabase

  Eligibility

Ages Eligible for Study:   8 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Biopsy confirmed oral lichen planus in combination with a compatible clinical appearance was used for diagnosis.

Exclusion Criteria:

  • Unable to undergo oral biopsy for diagnosis
  • Systemic diseases or malignancy
  • Pregnancy
  • Lesion/lesions with dysplasia/ history of allergic reaction to corticosteroids or immunomodulatory drugs.
  • Lesions adjacent to amalgam filling were also excluded from this study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01524744

Locations
Iran, Islamic Republic of
Mashhad University of Medical Science
Mashhad, Khorasan Razavi, Iran, Islamic Republic of, 91735
Sponsors and Collaborators
Mashhad University of Medical Sciences
Investigators
Principal Investigator: atessa pakfetrat, associate professor Mashhad University of Medical Science
  More Information

No publications provided

Responsible Party: ATESSA PAKFETRAT, Associate professor, Mashhad University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01524744     History of Changes
Other Study ID Numbers: 87909, 87909
Study First Received: January 31, 2012
Last Updated: February 1, 2012
Health Authority: Iran: Ethics Committee

Keywords provided by Mashhad University of Medical Sciences:
oral lichen planus treatment pimecrolimus

Additional relevant MeSH terms:
Lichen Planus
Lichen Planus, Oral
Lichenoid Eruptions
Skin Diseases, Papulosquamous
Skin Diseases
Mouth Diseases
Stomatognathic Diseases
Triamcinolone hexacetonide
Pimecrolimus
Triamcinolone
Triamcinolone Acetonide
Tacrolimus
Triamcinolone diacetate
Anti-Inflammatory Agents
Therapeutic Uses
 Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 21, 2013