The Efficacy of Topical Minocycline in Managing Symptomatic Oral Lichen Planus

March 8, 2010 updated by: Sheba Medical Center

The Efficacy of Topical Minocycline in Managing Symptomatic Oral Lichen Planus. A Randomized Controlled Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • OLP patients (Biopsy proven)

Exclusion Criteria:

  • Known allergy to Dexamethasone or Minocycline
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Dexamethasone
Dexamethasone 0.01% mouthwash
Drug: Dexamethasone
Dexamethasone 0.01% mouthwash
Experimental: Minocycline
Minocycline 0.2% mouthwash
Drug: Minocycline
Minocycline 0.2% mouthwash

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
symptoms relief
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Investigators

  • Principal Investigator: Noam Yarom, DMD, Sheba Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Anticipated)

March 1, 2011

Study Completion (Anticipated)

March 1, 2012

Study Registration Dates

First Submitted

March 7, 2010

First Submitted That Met QC Criteria

March 8, 2010

First Posted (Estimate)

March 9, 2010

Study Record Updates

Last Update Posted (Estimate)

March 9, 2010

Last Update Submitted That Met QC Criteria

March 8, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHEBA-09-7335-NY-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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