- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03026478
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
Study Overview
Status
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:
- 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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: KOMALI GARLAPATI, Professor
- Phone Number: +918008884945
- Email: komali_garlapati@yahoo.co.in
Study Contact Backup
- Name: PRATIMA SONI
- Phone Number: +919030295070
- Email: sonipratima4@gmail.com
Study Locations
-
-
Telangana
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Hyderabad, Telangana, India, 500060
- Recruiting
- Komali Garlapati
-
Contact:
- KOMALI GARLAPATI, M.D.S.
- Phone Number: +918008884945
- Email: komali_garlapati@yahoo.co.in
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
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
|
Other Names:
|
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
|
Other Names:
|
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
Sponsor
Investigators
- Principal Investigator: KOMALI GARLAPATI, PMVIDS & RC
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Stomatognathic Diseases
- Mouth Diseases
- Skin Diseases, Papulosquamous
- Lichenoid Eruptions
- Lichen Planus, Oral
- Lichen Planus
- Physiological Effects of Drugs
- Anti-Inflammatory Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Anti-Asthmatic Agents
- Respiratory System Agents
- Betamethasone
- Betamethasone Valerate
- Betamethasone-17,21-dipropionate
- Betamethasone benzoate
- Betamethasone sodium phosphate
- Clobetasol
Other Study ID Numbers
- PMVIDS&RC/IEC/OMR/DN/0003-15
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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