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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
Sponsor:
Information provided by (Responsible Party):
Garlapati Komali, Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre

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.

Condition or disease Intervention/treatment Phase
Oral Lichen Planus Drug: Betamethasone Dipropionate Drug: Clobetasol Propionate Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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


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 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




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: KOMALI GARLAPATI, Professor +918008884945 komali_garlapati@yahoo.co.in
Contact: PRATIMA SONI +919030295070 sonipratima4@gmail.com

Locations
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India
Komali Garlapati Recruiting
Hyderabad, Telangana, India, 500060
Contact: KOMALI GARLAPATI, M.D.S.    +918008884945    komali_garlapati@yahoo.co.in   
Sponsors and Collaborators
Garlapati Komali
Investigators
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Principal Investigator: KOMALI GARLAPATI PMVIDS & RC

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Responsible Party: Garlapati Komali, PROFESSOR, Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
ClinicalTrials.gov Identifier: NCT03026478     History of Changes
Other Study ID Numbers: PMVIDS&RC/IEC/OMR/DN/0003-15
First Posted: January 20, 2017    Key Record Dates
Last Update Posted: March 14, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Garlapati Komali, Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre:
oral lichen planus
betamethasone
clobetasol
orabase

Additional relevant MeSH terms:
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Lichen Planus
Lichen Planus, Oral
Lichenoid Eruptions
Skin Diseases, Papulosquamous
Skin Diseases
Mouth Diseases
Stomatognathic Diseases
Betamethasone
Betamethasone Valerate
Betamethasone-17,21-dipropionate
Betamethasone benzoate
Clobetasol
Betamethasone sodium phosphate
Benzocaine
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Peripheral Nervous System Agents