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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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2012 by ATESSA PAKFETRAT, Mashhad University of Medical Sciences.
Recruitment status was:  Enrolling by invitation
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
  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
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


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

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


Secondary Outcome Measures:
  • symptoms of oral lichen planus [ Time Frame: every 2 weeks ]
    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   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Keywords provided by ATESSA PAKFETRAT, 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
Pimecrolimus
Triamcinolone Acetonide
Tacrolimus
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antirheumatic Agents
Dermatologic Agents
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 21, 2017