The Efficacy of Topical Minocycline in Managing Symptomatic Oral Lichen Planus
The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Sheba Medical Center.
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
Sheba Medical Center
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01083420
First received: March 7, 2010
Last updated: March 8, 2010
Last verified: March 2010
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Oral Lichen Planus |
Drug: Minocycline Drug: Dexamethasone |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | The Efficacy of Topical Minocycline in Managing Symptomatic Oral Lichen Planus. A Randomized Controlled Trial |
Resource links provided by NLM:
Drug Information available for:
Dexamethasone
Dexamethasone acetate
Dexamethasone sodium phosphate
Minocycline
Minocycline hydrochloride
U.S. FDA Resources
Further study details as provided by Sheba Medical Center:
Primary Outcome Measures:
- symptoms relief [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | March 2010 |
| Estimated Study Completion Date: | March 2012 |
| Estimated Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Dexamethasone
Dexamethasone 0.01% mouthwash
|
Drug: Dexamethasone
Dexamethasone 0.01% mouthwash
|
|
Experimental: Minocycline
Minocycline 0.2% mouthwash
|
Drug: Minocycline
Minocycline 0.2% mouthwash
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- OLP patients (Biopsy proven)
Exclusion Criteria:
- Known allergy to Dexamethasone or Minocycline
- Pregnancy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01083420
Contacts
| Contact: Noam Yarom, DMD | +972-3-5303819 | noamyar@post.tau.ac.il |
Sponsors and Collaborators
Sheba Medical Center
Investigators
| Principal Investigator: | Noam Yarom, DMD | Sheba Medical Center |
More Information
No publications provided
| Responsible Party: | Dr. Noam Yarom, Sheba Medical Center |
| ClinicalTrials.gov Identifier: | NCT01083420 History of Changes |
| Other Study ID Numbers: | SHEBA-09-7335-NY-CTIL |
| Study First Received: | March 7, 2010 |
| Last Updated: | March 8, 2010 |
| Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
Keywords provided by Sheba Medical Center:
|
Oral lichen planus Minocycline Dexamethasone |
Additional relevant MeSH terms:
|
Lichen Planus Lichen Planus, Oral Lichenoid Eruptions Skin Diseases, Papulosquamous Skin Diseases Mouth Diseases Stomatognathic Diseases Dexamethasone acetate Dexamethasone Dexamethasone 21-phosphate BB 1101 Minocycline Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions |
Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on June 13, 2013