The Efficacy of Topical Minocycline in Managing Symptomatic Oral Lichen Planus

NCT ID: NCT01083420

Last Updated: 2010-03-09

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

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2012-03-31

Brief Summary

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The aim of the present study is to assess the clinical efficacy of topical minocyclin in managing of symptoms associated with oral lichen planus (OLP). The rationale of the study is based on our previous studies demonstrating the beneficial effect of minocyclin mouthwash on recurrent aphthous stomatitis. The planned study will be a randomized controlled, cross-over trail. Patients with symptomatic OLP will randomly receive minocycline or dexamethasone rinses.

The patients will rinse and expectorate 5 ml of the 1st mouthwash 4 times daily for 14 days. Subjects will complete a daily follow-up form that includes data regarding the daily intensity of pain (using VAS) caused by OLP and regarding possible side effects. After a washout period (at least 14 days) the patients will repeat the protocol with the second mouthwash.

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

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Dexamethasone

Dexamethasone 0.01% mouthwash

Group Type ACTIVE_COMPARATOR

Dexamethasone

Intervention Type DRUG

Dexamethasone 0.01% mouthwash

Minocycline

Minocycline 0.2% mouthwash

Group Type EXPERIMENTAL

Minocycline

Intervention Type DRUG

Minocycline 0.2% mouthwash

Interventions

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Minocycline

Minocycline 0.2% mouthwash

Intervention Type DRUG

Dexamethasone

Dexamethasone 0.01% mouthwash

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* OLP patients (Biopsy proven)

Exclusion Criteria

* Known allergy to Dexamethasone or Minocycline
* Pregnancy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Sheba Medical Center

Principal Investigators

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Noam Yarom, DMD

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center

Central Contacts

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Noam Yarom, DMD

Role: CONTACT

+972-3-5303819

Other Identifiers

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SHEBA-09-7335-NY-CTIL

Identifier Type: -

Identifier Source: org_study_id

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