The Efficacy of Topical Minocycline in Managing Symptomatic Oral Lichen Planus

Sheba Medical Center

Status and phase: Unknown; Phase 3

Conditions: Oral Lichen Planus

Treatments: Drug: Dexamethasone; Drug: Minocycline

Study type: Interventional

Funder types: Other

Identifiers

NCT01083420

SHEBA-09-7335-NY-CTIL

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• OLP patients (Biopsy proven)

Exclusion criteria

• Known allergy to Dexamethasone or Minocycline
• Pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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30 participants in 2 patient groups

Dexamethasone

Active Comparator group

Description:

Dexamethasone 0.01% mouthwash

Treatment:

Drug: Dexamethasone

Minocycline

Experimental group

Description:

Minocycline 0.2% mouthwash

Treatment:

Drug: Minocycline