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

Mashhad University of Medical Sciences

Status and phase: Unknown; Phase 2

Conditions: Oral Lichen Planus

Treatments: Drug: Pimecrolimus ointment; Drug: Adcortyl

Study type: Interventional

Funder types: Other

Identifiers

NCT01524744

87909 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 8+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

Pimecrolimus ointment 0.1 %

Active Comparator group

Description:

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

Treatment:

Drug: Adcortyl

Drug: Pimecrolimus ointment

Adcortyle

Active Comparator group

Description:

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

Treatment:

Drug: Adcortyl