NCT03026478

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 6, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 17, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 20, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

March 14, 2018

Status Verified

March 1, 2018

Enrollment Period

1.8 years

First QC Date

January 17, 2017

Last Update Submit

March 13, 2018

Conditions

Oral Lichen Planus

Keywords

oral lichen planusbetamethasoneclobetasolorabase

Outcome Measures

Primary Outcomes (1)

  • Based on Visual analog scale and size of the lesion

    study is in progress

    Each patient will be assessed for a total time frame of 1 month at a regular interval of 1 week.

Study Arms (2)

Betamethasone dipropionate 0.05%

EXPERIMENTAL

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

Drug: Betamethasone Dipropionate

Clobetasol propionate 0.05%

ACTIVE COMPARATOR

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

Interventions

Betamethasone DipropionateDRUG
Also known as: Betamethasone Dipropionate 0.05% gel
Betamethasone dipropionate 0.05%
Clobetasol PropionateDRUG
Also known as: Clobetasole Propionate 0.05% gel
Clobetasol propionate 0.05%

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Komali Garlapati

Hyderabad, Telangana, 500060, India

RECRUITING

MeSH Terms

Conditions

Lichen Planus, Oral

Interventions

betamethasone-17,21-dipropionateGelsClobetasol

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesLichen PlanusLichenoid EruptionsSkin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

ColloidsComplex MixturesDosage FormsPharmaceutical PreparationsBetamethasoneSteroids, FluorinatedSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • KOMALI GARLAPATI

    PMVIDS & RC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

KOMALI GARLAPATI, Professor

CONTACT

+918008884945komali_garlapati@yahoo.co.in

PRATIMA SONI

CONTACT

+919030295070sonipratima4@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PROFESSOR

Study Record Dates

First Submitted

January 17, 2017

First Posted

January 20, 2017

Study Start

May 6, 2016

Primary Completion

March 1, 2018

Study Completion

June 1, 2018

Last Updated

March 14, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)