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Topical Betamethasone and Clobetasol in Orabase in Oral Lichen Planus

Primary Purpose

Oral Lichen Planus

Status
Unknown status
Phase
Phase 2
Locations
India
Study Type
Interventional
Intervention
Betamethasone Dipropionate
Clobetasol Propionate
Sponsored by
Garlapati Komali
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oral Lichen Planus focused on measuring oral lichen planus, betamethasone, clobetasol, orabase

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Komali GarlapatiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Betamethasone dipropionate 0.05%

Clobetasol propionate 0.05%

Arm Description

topical Betamethasone dipropionate 0.05% in orabase with clotrimazole 1% in oral lichen planus two times a day for one month

Topical Clobetasol propionate 0.05% in orabase with clotrimazole 1% in oral lichen planus patients two times a day for a month

Outcomes

Primary Outcome Measures

Based on Visual analog scale and size of the lesion
study is in progress

Secondary Outcome Measures

Full Information

First Posted
January 17, 2017
Last Updated
March 13, 2018
Sponsor
Garlapati Komali
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1. Study Identification

Unique Protocol Identification Number
NCT03026478
Brief Title
Topical Betamethasone and Clobetasol in Orabase in Oral Lichen Planus
Official Title
A Comparative Study on Clinical Efficacy of Clobetasol and Betamethasone in Orabase in Combination With Clotrimazole, in Oral Lichen Planus
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 6, 2016 (Actual)
Primary Completion Date
March 2018 (Anticipated)
Study Completion Date
June 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Garlapati Komali

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Lichen Planus
Keywords
oral lichen planus, betamethasone, clobetasol, orabase

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Betamethasone dipropionate 0.05%
Arm Type
Experimental
Arm Description
topical Betamethasone dipropionate 0.05% in orabase with clotrimazole 1% in oral lichen planus two times a day for one month
Arm Title
Clobetasol propionate 0.05%
Arm Type
Active Comparator
Arm Description
Topical Clobetasol propionate 0.05% in orabase with clotrimazole 1% in oral lichen planus patients two times a day for a month
Intervention Type
Drug
Intervention Name(s)
Betamethasone Dipropionate
Other Intervention Name(s)
Betamethasone Dipropionate 0.05% gel
Intervention Type
Drug
Intervention Name(s)
Clobetasol Propionate
Other Intervention Name(s)
Clobetasole Propionate 0.05% gel
Primary Outcome Measure Information:
Title
Based on Visual analog scale and size of the lesion
Description
study is in progress
Time Frame
Each patient will be assessed for a total time frame of 1 month at a regular interval of 1 week.

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with Oral Lichen Planus, who are willing to participate in the study. Patients who are physically healthy and well oriented in time, space and as a person. Patients clinically and histopathologically diagnosed with Oral Lichen Planus. Patients with symptoms i.e. pain and burning sensation due to oral lichen planus. Exclusion Criteria: Patients with Oral Lichen Planus, who are not willing to participate in the study. Patients with any other mucosal disease or any other skin disease which may be associated with oral lesions. Patients with a known allergy or contraindication to study medications. Patients with known history of systemic diseases, where steroids are contraindicated. Pregnant women.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
KOMALI GARLAPATI, Professor
Phone
+918008884945
Email
komali_garlapati@yahoo.co.in
First Name & Middle Initial & Last Name or Official Title & Degree
PRATIMA SONI
Phone
+919030295070
Email
sonipratima4@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
KOMALI GARLAPATI
Organizational Affiliation
PMVIDS & RC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Komali Garlapati
City
Hyderabad
State/Province
Telangana
ZIP/Postal Code
500060
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
KOMALI GARLAPATI, M.D.S.
Phone
+918008884945
Email
komali_garlapati@yahoo.co.in

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Topical Betamethasone and Clobetasol in Orabase in Oral Lichen Planus

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