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The Efficacy of Topical Minocycline in Managing Symptomatic Oral Lichen Planus

Primary Purpose

Oral Lichen Planus

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Minocycline
Dexamethasone
Sponsored by
Sheba Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oral Lichen Planus focused on measuring Oral lichen planus, Minocycline, Dexamethasone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • OLP patients (Biopsy proven)

Exclusion Criteria:

  • Known allergy to Dexamethasone or Minocycline
  • Pregnancy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Dexamethasone

    Minocycline

    Arm Description

    Dexamethasone 0.01% mouthwash

    Minocycline 0.2% mouthwash

    Outcomes

    Primary Outcome Measures

    symptoms relief

    Secondary Outcome Measures

    Full Information

    First Posted
    March 7, 2010
    Last Updated
    March 8, 2010
    Sponsor
    Sheba Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01083420
    Brief Title
    The Efficacy of Topical Minocycline in Managing Symptomatic Oral Lichen Planus
    Official Title
    The Efficacy of Topical Minocycline in Managing Symptomatic Oral Lichen Planus. A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2010
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 2010 (undefined)
    Primary Completion Date
    March 2011 (Anticipated)
    Study Completion Date
    March 2012 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Sheba Medical Center

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Oral Lichen Planus
    Keywords
    Oral lichen planus, Minocycline, Dexamethasone

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Dexamethasone
    Arm Type
    Active Comparator
    Arm Description
    Dexamethasone 0.01% mouthwash
    Arm Title
    Minocycline
    Arm Type
    Experimental
    Arm Description
    Minocycline 0.2% mouthwash
    Intervention Type
    Drug
    Intervention Name(s)
    Minocycline
    Intervention Description
    Minocycline 0.2% mouthwash
    Intervention Type
    Drug
    Intervention Name(s)
    Dexamethasone
    Intervention Description
    Dexamethasone 0.01% mouthwash
    Primary Outcome Measure Information:
    Title
    symptoms relief
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: OLP patients (Biopsy proven) Exclusion Criteria: Known allergy to Dexamethasone or Minocycline Pregnancy
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Noam Yarom, DMD
    Phone
    +972-3-5303819
    Email
    noamyar@post.tau.ac.il
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Noam Yarom, DMD
    Organizational Affiliation
    Sheba Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    The Efficacy of Topical Minocycline in Managing Symptomatic Oral Lichen Planus

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