Treatment for the local application of oral ulcers seen in Oral Lichen Planus

Comparative evaluation of efficacy of topical Clobetasol propionate, Nano-bio fusion gel (NBF Gel) and Curcumin oral gel in the management of Oral Lichen Planus

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/08/015185

Enrollment

120

Registered

2018-08-03

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Oral Lichen Planus

Interventions

Intervention1: Clobetasol Propionate (0.05%)ointment: The drug would be given topically Patient would be asked to apply it with the help of finger on all the involved surfaces and to keep it there for

Eligibility

Inclusion criteria

Inclusion criteria: Clinically determined cases of oral lichen planus Histopathologically confirmed cases of oral Lichen Planus. 20-65 years of age Individuals compliant and ready for study procedure and who will give written consent to undergo the study willingly. Â

Exclusion criteria

Exclusion criteria: All asymptomatic cases. Patients with the history of use of antibiotics within one month or immunomodulating agents within 3 months. Presence of lichenoid reactions caused by amalgam fillings, drugs etc. Pregnancy and nursing mothers. Patients having uncontrolled diabetes mellitus, hypertension, acidity, immunocompromised conditions. Individuals with known history of allergy or hypersensitivity to drugs under trial. Patients who are unwilling to undergo the study and do not give informed consent.

Design outcomes

Primary

Measure	Time frame
Burning sensation evaluation with the help of VAS Scale Clinical improvement of the lesion will be assessed by M. Escudier et al scale Timepoint: Patient will be recalled and assessed after 1 week of the beginning of treatment (findings would be recorded). This weekly follow up would continue for a period of 1 month. After one month patient would be recalled after every 15 days for next two months.	—

Measure

Time frame

Burning sensation evaluation with the help of VAS Scale Clinical improvement of the lesion will be assessed by M. Escudier et al scale Timepoint: Patient will be recalled and assessed after 1 week of the beginning of treatment (findings would be recorded). This weekly follow up would continue for a period of 1 month. After one month patient would be recalled after every 15 days for next two months.

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Secondary

Measure	Time frame
Mucosal atrophy Candidiasis Estimation of malignant transformation rate of OLPTimepoint: Patient will be recalled and assessed after 1 week of the beginning of treatment (findings would be recorded). This weekly follow up would continue for a period of 1 month. After one month patient would be recalled after every 15 days for next two months. During all these follow ups all the side effects would be noted down Malignant potential will be assessed after 1 week of enlollment of patient for study when their biopsy report comes	—

Measure

Time frame

Mucosal atrophy Candidiasis Estimation of malignant transformation rate of OLPTimepoint: Patient will be recalled and assessed after 1 week of the beginning of treatment (findings would be recorded). This weekly follow up would continue for a period of 1 month. After one month patient would be recalled after every 15 days for next two months. During all these follow ups all the side effects would be noted down Malignant potential will be assessed after 1 week of enlollment of patient for study when their biopsy report comes

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Countries

India

Contacts

Public ContactPriyanka Verma

Maulana Azad Institute of Dental Sciences

drsunitagupta@yahoo.com9654700955

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026