Comparison of Tacrolimus 0.1% and Clobetasol 0.05% in the Management of Symptomatic Oral Lichen Planus

NCT ID: NCT02744378

Last Updated: 2016-04-20

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2015-12-31

Brief Summary

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This clinical study is carried out to assess the efficacy of Tacrolimus and Clobetasol in symptomatic Oral Lichen Planus.

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

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Clobetasol Group

clobetasol propionate (0.05%) cream

Group Type ACTIVE_COMPARATOR

Clobetasol 0.05%

Intervention Type DRUG

This group was randomly allocated to receive topical Clobetasol 0.05% for 3 consecutive weeks

Tacrolimus Group

tacrolimus (0.1%) cream

Group Type ACTIVE_COMPARATOR

Tacrolimus 0.1%

Intervention Type DRUG

This group was randomly allocated to receive topical Tacrolimus 0.1% for 3 consecutive weeks

Interventions

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Tacrolimus 0.1%

This group was randomly allocated to receive topical Tacrolimus 0.1% for 3 consecutive weeks

Intervention Type DRUG

Clobetasol 0.05%

This group was randomly allocated to receive topical Clobetasol 0.05% for 3 consecutive weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Clinically and Histologically proven Oral Lichen Planus
* Symptomatic

Exclusion Criteria

* topical/ systemic medication for OLP in the previous three months
* contraindication for medications use such as a history of allergy to either corticosteroids/ tacrolimus
* immunosuppression, or pregnant / lactating females
* lichenoid reactions either drug induced or due to dental amalgam
* diabetes mellitus and on oral hypoglycemic drugs
* systemic involvement such as concurrent skin/genital lesions
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Peradeniya

OTHER

Sponsor Role lead

Responsible Party

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Dr. P.V.K.S Hettiarachchi

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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RG/2013/08/D

Identifier Type: -

Identifier Source: org_study_id

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