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

NCT ID: NCT01524744

Last Updated: 2012-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2012-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Oral Lichen Planus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Pimecrolimus ointment

Intervention Type DRUG

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

Adcortyl

Intervention Type DRUG

triamcinolone acetonide 0.1% in orabase

Adcortyle

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

Group Type ACTIVE_COMPARATOR

Adcortyl

Intervention Type DRUG

triamcinolone acetonide 0.1% in orabase

Interventions

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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

Intervention Type DRUG

Adcortyl

triamcinolone acetonide 0.1% in orabase

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mashhad University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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ATESSA PAKFETRAT

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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atessa pakfetrat, associate professor

Role: PRINCIPAL_INVESTIGATOR

Mashhad University of Medical Science

Locations

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Mashhad University of Medical Science

Mashhad, Khorasan Razavi, Iran

Site Status

Countries

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Iran

Other Identifiers

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87909

Identifier Type: OTHER

Identifier Source: secondary_id

87909

Identifier Type: -

Identifier Source: org_study_id

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