The Efficacy of Topical Minocycline in Managing Symptomatic Oral Lichen Planus

Overview

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.

Full Title of Study: “The Efficacy of Topical Minocycline in Managing Symptomatic Oral Lichen Planus. A Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: March 2011

Interventions

  • Drug: Minocycline
    • Minocycline 0.2% mouthwash
  • Drug: Dexamethasone
    • Dexamethasone 0.01% mouthwash

Arms, Groups and Cohorts

  • Active Comparator: Dexamethasone
    • Dexamethasone 0.01% mouthwash
  • Experimental: Minocycline
    • Minocycline 0.2% mouthwash

Clinical Trial Outcome Measures

Primary Measures

  • symptoms relief
    • Time Frame: 2 years

Participating in This Clinical Trial

Inclusion Criteria

  • OLP patients (Biopsy proven) Exclusion Criteria:

  • Known allergy to Dexamethasone or Minocycline – Pregnancy

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sheba Medical Center
  • Provider of Information About this Clinical Study
    • Dr. Noam Yarom, Sheba Medical Center
  • Overall Official(s)
    • Noam Yarom, DMD, Principal Investigator, Sheba Medical Center
  • Overall Contact(s)
    • Noam Yarom, DMD, +972-3-5303819, noamyar@post.tau.ac.il

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