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
About this trial
This is an interventional treatment trial for Oral Lichen Planus focused on measuring oral lichen planus treatment pimecrolimus
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.
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
NCT ID
NCT01524744
First Posted
January 31, 2012
Last Updated
February 1, 2012
Sponsor
Mashhad University of Medical Sciences
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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