Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  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:


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
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

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
Mouth Diseases
Skin Diseases
Skin Diseases, Papulosquamous
Stomatognathic Diseases
Pimecrolimus
Tacrolimus
Triamcinolone Acetonide
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Dermatologic Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunologic Factors
Immunosuppressive Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014