The Efficacy of Topical Minocycline in Managing Symptomatic Oral Lichen Planus

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Sheba Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01083420
First received: March 7, 2010
Last updated: March 8, 2010
Last verified: March 2010
  Purpose

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 Intervention Phase
Oral Lichen Planus
Drug: Minocycline
Drug: Dexamethasone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Efficacy of Topical Minocycline in Managing Symptomatic Oral Lichen Planus. A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • symptoms relief [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: March 2010
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • OLP patients (Biopsy proven)

Exclusion Criteria:

  • Known allergy to Dexamethasone or Minocycline
  • Pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01083420

Contacts
Contact: Noam Yarom, DMD +972-3-5303819 noamyar@post.tau.ac.il

Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Noam Yarom, DMD Sheba Medical Center
  More Information

No publications provided

Responsible Party: Dr. Noam Yarom, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01083420     History of Changes
Other Study ID Numbers: SHEBA-09-7335-NY-CTIL
Study First Received: March 7, 2010
Last Updated: March 8, 2010
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:
Oral lichen planus
Minocycline
Dexamethasone

Additional relevant MeSH terms:
Lichen Planus
Lichen Planus, Oral
Lichenoid Eruptions
Mouth Diseases
Skin Diseases
Skin Diseases, Papulosquamous
Stomatognathic Diseases
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Minocycline
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Enzyme Inhibitors
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors

ClinicalTrials.gov processed this record on October 20, 2014