The Efficacy of Topical Minocycline in Managing Symptomatic Oral Lichen Planus
Information source: Sheba Medical Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Oral Lichen Planus
Intervention: Minocycline (Drug); Dexamethasone (Drug)
Phase: Phase 3
Status: Not yet recruiting
Sponsored by: Sheba Medical Center Official(s) and/or principal investigator(s): Noam Yarom, DMD, Principal Investigator, Affiliation: Sheba Medical Center
Overall contact: Noam Yarom, DMD, Phone: +972-3-5303819, Email: noamyar@post.tau.ac.il
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.
Clinical Details
Official title: The Efficacy of Topical Minocycline in Managing Symptomatic Oral Lichen Planus. A Randomized Controlled Trial
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: symptoms relief
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- OLP patients (Biopsy proven)
Exclusion Criteria:
- Known allergy to Dexamethasone or Minocycline
- Pregnancy
Locations and Contacts
Noam Yarom, DMD, Phone: +972-3-5303819, Email: noamyar@post.tau.ac.il Additional Information
Starting date: March 2010
Last updated: March 8, 2010
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