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Topical Betamethasone and Clobetasol in Orabase in Oral Lichen Planus

A Comparative Study on Clinical Efficacy of Clobetasol and Betamethasone in Orabase in Combination With Clotrimazole, in Oral Lichen Planus

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03026478
Enrollment
30
Registered
2017-01-20
Start date
2016-05-06
Completion date
2018-06-30
Last updated
2018-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral Lichen Planus

Keywords

oral lichen planus, betamethasone, clobetasol, orabase

Brief summary

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.

Detailed description

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: 1. Patients with Oral Lichen Planus, who are willing to participate in the study. 2. Patients who are physically healthy and well oriented in time, space and as a person. 3. Patients clinically and histopathologically diagnosed with Oral Lichen Planus. 4. Patients with symptoms i.e. pain and burning sensation due to oral lichen planus. Exclusion Criteria : 1. Patients with Oral Lichen Planus, who are not willing to participate in the study. 2. Patients with any other mucosal disease or any other skin disease which may be associated with oral lesions. 3. Patients with a known allergy or contraindication to study medications. 4. Patients with systemic diseases, where steroids are contraindicated. 5. Pregnant women.

Interventions

Sponsors

Garlapati Komali
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

1. Patients with Oral Lichen Planus, who are willing to participate in the study. 2. Patients who are physically healthy and well oriented in time, space and as a person. 3. Patients clinically and histopathologically diagnosed with Oral Lichen Planus. 4. Patients with symptoms i.e. pain and burning sensation due to oral lichen planus.

Exclusion criteria

1. Patients with Oral Lichen Planus, who are not willing to participate in the study. 2. Patients with any other mucosal disease or any other skin disease which may be associated with oral lesions. 3. Patients with a known allergy or contraindication to study medications. 4. Patients with known history of systemic diseases, where steroids are contraindicated. 5. Pregnant women.

Design outcomes

Primary

MeasureTime frameDescription
Based on Visual analog scale and size of the lesionEach patient will be assessed for a total time frame of 1 month at a regular interval of 1 week.study is in progress

Countries

India

Contacts

Primary ContactKOMALI GARLAPATI, Professor
komali_garlapati@yahoo.co.in+918008884945
Backup ContactPRATIMA SONI
sonipratima4@gmail.com+919030295070

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026