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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01524744

Enrollment

Registered

2012-02-02

Start date

2009-03-31

Completion date

2012-12-31

Last updated

2012-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral Lichen Planus

Keywords

oral lichen planus treatment pimecrolimus

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.

Interventions

DRUGPimecrolimus ointment

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

DRUGAdcortyl

triamcinolone acetonide 0.1% in orabase

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

8 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
signs of oral lichen planus	every 2 weeks	size and type of oral lichen planus has been recorded

Secondary

Measure	Time frame	Description
symptoms of oral lichen planus	every 2 weeks	pain of oral lesions has been recorded

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026