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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

Primary Purpose

Oral Lichen Planus

Status
Unknown status
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Pimecrolimus ointment
Adcortyl
Sponsored by
Mashhad University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oral Lichen Planus focused on measuring oral lichen planus treatment pimecrolimus

Eligibility Criteria

8 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mashhad University of Medical Science

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Pimecrolimus ointment 0.1 %

Adcortyle

Arm Description

This group used drugs 3 times a day for 2 months and then didn't eat or drink for 20 minutes after use

Control group used adcortyle (triamcinolone acetonide 0.1% in orabase, Bristol-Myers Squibbb, Anagn, Italy)

Outcomes

Primary Outcome Measures

signs of oral lichen planus
size and type of oral lichen planus has been recorded

Secondary Outcome Measures

symptoms of oral lichen planus
pain of oral lesions has been recorded

Full Information

First Posted
January 31, 2012
Last Updated
February 1, 2012
Sponsor
Mashhad University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01524744
Brief Title
A Randomized Clinical Trial of the Effect of Pimecrolimus Cream 1% Compared With Topical Corticosteroid in Treatment of Erosive Oral Lichen Planus
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Unknown status
Study Start Date
March 2009 (undefined)
Primary Completion Date
October 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mashhad University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Lichen Planus
Keywords
oral lichen planus treatment pimecrolimus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pimecrolimus ointment 0.1 %
Arm Type
Active Comparator
Arm Description
This group used drugs 3 times a day for 2 months and then didn't eat or drink for 20 minutes after use
Arm Title
Adcortyle
Arm Type
Active Comparator
Arm Description
Control group used adcortyle (triamcinolone acetonide 0.1% in orabase, Bristol-Myers Squibbb, Anagn, Italy)
Intervention Type
Drug
Intervention Name(s)
Pimecrolimus ointment
Intervention Description
Case group used drugs 3 times a day for 2 months and then didn't eat or drink for 20 minutes after use
Intervention Type
Drug
Intervention Name(s)
Adcortyl
Intervention Description
triamcinolone acetonide 0.1% in orabase
Primary Outcome Measure Information:
Title
signs of oral lichen planus
Description
size and type of oral lichen planus has been recorded
Time Frame
every 2 weeks
Secondary Outcome Measure Information:
Title
symptoms of oral lichen planus
Description
pain of oral lesions has been recorded
Time Frame
every 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
atessa pakfetrat, associate professor
Organizational Affiliation
Mashhad University of Medical Science
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mashhad University of Medical Science
City
Mashhad
State/Province
Khorasan Razavi
ZIP/Postal Code
91735
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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