Topical Betamethasone and Clobetasol in Orabase in Oral Lichen Planus

March 13, 2018 updated by: Garlapati Komali

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Telangana
      • Hyderabad, Telangana, India, 500060

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Betamethasone dipropionate 0.05%
topical Betamethasone dipropionate 0.05% in orabase with clotrimazole 1% in oral lichen planus two times a day for one month
Drug: Betamethasone Dipropionate
Other Names:
  • Betamethasone Dipropionate 0.05% gel
Active Comparator: Clobetasol propionate 0.05%
Topical Clobetasol propionate 0.05% in orabase with clotrimazole 1% in oral lichen planus patients two times a day for a month
Drug: Clobetasol Propionate
Other Names:
  • Clobetasole Propionate 0.05% gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Based on Visual analog scale and size of the lesion
Time Frame: Each patient will be assessed for a total time frame of 1 month at a regular interval of 1 week.
study is in progress
Each patient will be assessed for a total time frame of 1 month at a regular interval of 1 week.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Garlapati Komali

Investigators

  • Principal Investigator: KOMALI GARLAPATI, PMVIDS & RC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 6, 2016

Primary Completion (Anticipated)

March 1, 2018

Study Completion (Anticipated)

June 1, 2018

Study Registration Dates

First Submitted

January 17, 2017

First Submitted That Met QC Criteria

January 19, 2017

First Posted (Estimate)

January 20, 2017

Study Record Updates

Last Update Posted (Actual)

March 14, 2018

Last Update Submitted That Met QC Criteria

March 13, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PMVIDS&RC/IEC/OMR/DN/0003-15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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