Topical Betamethasone and Clobetasol in Orabase in Oral Lichen Planus
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|ClinicalTrials.gov Identifier: NCT03026478|
Recruitment Status : Recruiting
First Posted : January 20, 2017
Last Update Posted : March 14, 2018
|Condition or disease||Intervention/treatment||Phase|
|Oral Lichen Planus||Drug: Betamethasone Dipropionate Drug: Clobetasol Propionate||Phase 2|
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.
A total of 30 patients will be randomly divided into 2 groups with 15 patients in each group.
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%.
- 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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Comparative Study on Clinical Efficacy of Clobetasol and Betamethasone in Orabase in Combination With Clotrimazole, in Oral Lichen Planus|
|Actual Study Start Date :||May 6, 2016|
|Estimated Primary Completion Date :||March 2018|
|Estimated Study Completion Date :||June 2018|
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 Name: 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 Name: Clobetasole Propionate 0.05% gel
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03026478
|Contact: KOMALI GARLAPATI, Professorfirstname.lastname@example.org|
|Contact: PRATIMA SONIemail@example.com|
|Hyderabad, Telangana, India, 500060|
|Contact: KOMALI GARLAPATI, M.D.S. +918008884945 firstname.lastname@example.org|
|Principal Investigator:||KOMALI GARLAPATI||PMVIDS & RC|