The Efficacy of Topical Minocycline in Managing Symptomatic Oral Lichen Planus
1 other identifier
interventional
30
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Mar 2010
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 7, 2010
CompletedFirst Posted
Study publicly available on registry
March 9, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedMarch 9, 2010
March 1, 2010
1 year
March 7, 2010
March 8, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
symptoms relief
2 years
Study Arms (2)
Dexamethasone
ACTIVE COMPARATORDexamethasone 0.01% mouthwash
Minocycline
EXPERIMENTALMinocycline 0.2% mouthwash
Interventions
Eligibility Criteria
You may qualify if:
- OLP patients (Biopsy proven)
You may not qualify if:
- Known allergy to Dexamethasone or Minocycline
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Noam Yarom, DMD
Sheba Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
March 7, 2010
First Posted
March 9, 2010
Study Start
March 1, 2010
Primary Completion
March 1, 2011
Study Completion
March 1, 2012
Last Updated
March 9, 2010
Record last verified: 2010-03