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

February 1, 2012 updated by: ATESSA PAKFETRAT, Mashhad University of Medical Sciences
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran, Islamic Republic of
    • Khorasan Razavi
      • Mashhad, Khorasan Razavi, Iran, Islamic Republic of, 91735
        • Mashhad University of Medical Science

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
signs of oral lichen planus
Time Frame: every 2 weeks
size and type of oral lichen planus has been recorded
every 2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
symptoms of oral lichen planus
Time Frame: every 2 weeks
pain of oral lesions has been recorded
every 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mashhad University of Medical Sciences

Investigators

  • Principal Investigator: atessa pakfetrat, associate professor, Mashhad University of Medical Science

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Anticipated)

October 1, 2012

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

January 31, 2012

First Submitted That Met QC Criteria

February 1, 2012

First Posted (Estimate)

February 2, 2012

Study Record Updates

Last Update Posted (Estimate)

February 2, 2012

Last Update Submitted That Met QC Criteria

February 1, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 87909 (Other Identifier: 87909)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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