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Oral Lichen Planus (OLP) is an autoimmune, chronic inflammatory mucocutaneous disease characterized by pain and burning sensation. The major types of OLP are the following: reticular, atrophic, erosive-ulcerative, bullous and pigmentous form.Its etiology remains unclear. The presence of auto-cytotoxic T cell clones in the lesions suggests the role of autoimmunity. Numerous treatment options of OLP include topical and systemic agents depending on severity of lesions . Topical corticosteroids abide the mainstay of therapy,and are widely accepted as the primary treatment of choice.Hence this study is designed to evaluate and compare the clinical efficacy of topical Clobetasol 0.05% in orabase and Betamethasone 0.05% in orabase in combination with Clotrimazole 1% in the management of symptomatic Oral Lichen Planus.
Patients of either sex, irrespective of age attending the Department of Oral Medicine & Radiology, Panineeya Mahavidhyalaya Institute of Dental Sciences and Research Centre, Hyderabad who are clinically and histopathologically diagnosed with Oral Lichen Planus shall be included in the study group after obtaining an informed consent from the patients.
Study design: Prospective study.
Sample size:
A total of 30 patients will be randomly divided into 2 groups with 15 patients in each group.
Methodology:
30 patients who are diagnosed with Oral Lichen Planus by clinical and histopathological examination will be randomly assigned into 2 drug groups and burning sensation will be assessed by VAS Scale and also clinical improvement will be assessed at interval of 1 week till 4 weeks.
GROUP A: This group of patients will receive topical Clobetasol 0.05% in orabase and Clotrimazole 1%.
GROUP B: This group of patients will receive topical Betamethasone 0.05% in orabase and Clotrimazole 1%.
Inclusion criteria:
Exclusion Criteria :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Betamethasone dipropionate 0.05% | Experimental | topical Betamethasone dipropionate 0.05% in orabase with clotrimazole 1% in oral lichen planus two times a day for one month |
|
| Clobetasol propionate 0.05% | Active Comparator | Topical Clobetasol propionate 0.05% in orabase with clotrimazole 1% in oral lichen planus patients two times a day for a month |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Betamethasone Dipropionate | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Based on Visual analog scale and size of the lesion | study is in progress | Each patient will be assessed for a total time frame of 1 month at a regular interval of 1 week. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| KOMALI GARLAPATI, Professor | Contact | +918008884945 | komali_garlapati@yahoo.co.in | |
| PRATIMA SONI | Contact | +919030295070 | sonipratima4@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| KOMALI GARLAPATI | PMVIDS & RC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Komali Garlapati | Recruiting | Hyderabad | Telangana | 500060 | India |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 22, 2025 | |
| Reset | Jul 10, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 22, 2025 | Jul 10, 2025 |
| ID | Term |
|---|---|
| D017676 | Lichen Planus, Oral |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D008010 | Lichen Planus |
| D017512 | Lichenoid Eruptions |
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| ID | Term |
|---|---|
| C011175 | betamethasone-17,21-dipropionate |
| D005782 | Gels |
| D002990 | Clobetasol |
| ID | Term |
|---|---|
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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| Clobetasol Propionate |
| Drug |
|
|
| D017444 |
| Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001623 |
| Betamethasone |
| D013259 | Steroids, Fluorinated |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |