The Efficacy of Topical Minocycline in Managing Symptomatic Oral Lichen Planus

Phase 3

• Conditions: Oral Lichen Planus
• Interventions: Drug: Dexamethasone; Drug: Minocycline

• Registration Number: NCT01083420
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-03
• Study Start: 2010-03
• Study First Submitted: 2010-03-07
• Study First Submitted QC: 2010-03-08
• Last Update Submitted: 2010-03-08
• Study First Posted: 2010-03-09
• Last Update Posted: 2010-03-09
• Primary Completion: 2011-03
• Study Completion: 2012-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• OLP patients (Biopsy proven)

Exclusion Criteria

• Known allergy to Dexamethasone or Minocycline
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Dexamethasone	Dexamethasone	Dexamethasone 0.01% mouthwash
Minocycline	Minocycline	Minocycline 0.2% mouthwash

Primary Outcome Measures

Name	Time	Method
symptoms relief	2 years