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

Phase 2

• Conditions: Oral Lichen Planus
• Interventions: Drug: Pimecrolimus ointment; Drug: Adcortyl

• Registration Number: NCT01524744
• Lead Sponsor: Mashhad University of Medical Sciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Status Verified: 2012-01
• Study First Submitted: 2012-01-31
• Study First Submitted QC: 2012-02-01
• Last Update Submitted: 2012-02-01
• Study First Posted: 2012-02-02
• Last Update Posted: 2012-02-02
• Primary Completion: 2012-10
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pimecrolimus ointment 0.1 %	Pimecrolimus ointment	This group used drugs 3 times a day for 2 months and then didn't eat or drink for 20 minutes after use
Pimecrolimus ointment 0.1 %	Adcortyl	This group used drugs 3 times a day for 2 months and then didn't eat or drink for 20 minutes after use
Adcortyle	Adcortyl	Control group used adcortyle (triamcinolone acetonide 0.1% in orabase, Bristol-Myers Squibbb, Anagn, Italy)

Primary Outcome Measures

Name	Time	Method
signs of oral lichen planus	every 2 weeks	size and type of oral lichen planus has been recorded

Secondary Outcome Measures

Name	Time	Method
symptoms of oral lichen planus	every 2 weeks	pain of oral lesions has been recorded

Trial Locations

Locations (1)

Mashhad University of Medical Science; 🇮🇷 Mashhad, Khorasan Razavi, Iran, Islamic Republic of