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NCT01083420 Clinical Trial

The Efficacy of Topical Minocycline in Managing Symptomatic Oral Lichen Planus

Oral Lichen Planus Clinical Trial

Official title:
The Efficacy of Topical Minocycline in Managing Symptomatic Oral Lichen Planus. A Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT01083420
Other study ID # SHEBA-09-7335-NY-CTIL
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received March 7, 2010
Last updated March 8, 2010
Start date March 2010
Est. completion date March 2012

Study information
Verified date March 2010
Source Sheba Medical Center
Contact Noam Yarom, DMD
Phone +972-3-5303819
Email noamyar@post.tau.ac.il
Is FDA regulated No
Health authority Israel: Israeli Health Ministry Pharmaceutical Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 30
Est. completion date March 2012
Est. primary completion date March 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- OLP patients (Biopsy proven)

Exclusion Criteria:

- Known allergy to Dexamethasone or Minocycline

- Pregnancy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Minocycline
Minocycline 0.2% mouthwash
• Dexamethasone
Dexamethasone 0.01% mouthwash

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Sheba Medical Center

Outcome
Type Measure Description Time frame Safety issue
Primary symptoms relief 2 years No
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