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The Efficacy of Topical Minocycline in Managing Symptomatic Oral Lichen Planus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01083420
Recruitment Status : Unknown
Verified March 2010 by Sheba Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : March 9, 2010
Last Update Posted : March 9, 2010
Information provided by:
Sheba Medical Center

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.

Condition or disease Intervention/treatment Phase
Oral Lichen Planus Drug: Minocycline Drug: Dexamethasone Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Efficacy of Topical Minocycline in Managing Symptomatic Oral Lichen Planus. A Randomized Controlled Trial
Study Start Date : March 2010
Estimated Primary Completion Date : March 2011
Estimated Study Completion Date : March 2012

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

Primary Outcome Measures :
  1. symptoms relief [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • OLP patients (Biopsy proven)

Exclusion Criteria:

  • Known allergy to Dexamethasone or Minocycline
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01083420

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Contact: Noam Yarom, DMD +972-3-5303819

Sponsors and Collaborators
Sheba Medical Center
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Principal Investigator: Noam Yarom, DMD Sheba Medical Center
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Responsible Party: Dr. Noam Yarom, Sheba Medical Center Identifier: NCT01083420    
Other Study ID Numbers: SHEBA-09-7335-NY-CTIL
First Posted: March 9, 2010    Key Record Dates
Last Update Posted: March 9, 2010
Last Verified: March 2010
Keywords provided by Sheba Medical Center:
Oral lichen planus
Additional relevant MeSH terms:
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Lichen Planus, Oral
Lichen Planus
Lichenoid Eruptions
Skin Diseases, Papulosquamous
Skin Diseases
Mouth Diseases
Stomatognathic Diseases
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anti-Bacterial Agents
Anti-Infective Agents