| CTRI Number |
CTRI/2025/02/080456 [Registered on: 13/02/2025] Trial Registered Prospectively |
| Last Modified On: |
12/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare the effectiveness of topical Roflumilasr 0.3 percent and topical Triamcinolone 0.1 percent in Oral Lichen Planus patients. |
|
Scientific Title of Study
|
Comparative effectiveness of topical Roflumilast 0.3 percent vs Triamcinolone acetonide 0.1 percent in symptomatic Oral Lichen Planus patients: a randomized controlled trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
KRITIKA TIWARI |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Faculty of Dental Sciences Institute of Medical Sciences Uttar Pradesh |
| Address |
Oral Medicine and Radiology, Room no 1, Faculty of Dental Sciences, Banaras Hindu University
Lanka, Varanasi, Uttar Pradesh
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9569897813 |
| Fax |
|
| Email |
Krikx29tiwari@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Adit |
| Designation |
Professor and Head, Unit of Oral Medicine and Radiology |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University |
| Address |
Unit of Oral Medicine and Radiology, Faculty of Dental Sciences,
Institute of Medical Sciences, Banaras Hindu University
Varanasi
UTTAR PRADESH
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9451525522 |
| Fax |
|
| Email |
adit@bhu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Adit |
| Designation |
Professor and Head, Unit of Oral Medicine and Radiology |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University |
| Address |
Unit of Oral Medicine and Radiology, Faculty of Dental Sciences,
Institute of Medical Sciences, Banaras Hindu University
Varanasi
UTTAR PRADESH
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9451525522 |
| Fax |
|
| Email |
adit@bhu.ac.in |
|
|
Source of Monetary or Material Support
|
| Unit of Oral Medicine and Radiology, Faculty of Dental Sciences, Institute of Medical Sciences,
Banaras Hindu University, Varanasi (221005), India. |
|
|
Primary Sponsor
|
| Name |
KRITIKA TIWARI |
| Address |
Unit of Oral Medicine and Radiology, Faculty of Dental Sciences,
Institute of Medical Sciences, Banaras Hindu UNiversity |
| Type of Sponsor |
Other [(SELF)] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Adit |
Faculty of Dental Sciences, Institute of Medical Sciences, Banaras Hindu University |
Room no. 1,Unit of Oral Medicine
and Radiology, Faculty of Dental Sciences
Varanasi
UTTAR PRADESH |
9451525522
adit@bhu.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Institute Of Medical Sciences, Banaras Hindu University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L439||Lichen planus, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Topical Roflumilast 0.3% |
Topical application of Roflumilast 0.3% in symptomatic Oral Lichen Planus patients with followup on baseline, 1,2 and 3 months. |
| Comparator Agent |
Topical Triamcinolone acetonide 0.1% |
Topical application of Triamcinolone acetonide 0.1% in symptomatic Oral Lichen Planus patients with followup on baseline, 1,2 and 3 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Participants of both gender and age between 18 years to 60 years, will be diagnosed with symptomatic lesions of reticular, atrophic, and erosive oral lichen planus based on clinical, histopathological criteria by WHO.
Patients who give informed consent after explaining the treatment type will be included in the study.
|
|
| ExclusionCriteria |
| Details |
Patients with any other Potentially Malignant Oral Disorders (PMOD) will be excluded.
Pregnant females and breastfeeding mothers will be excluded.
Patients with a history of corticosteroids, NSAIDs, or any other treatment in the last 30 days will be excluded.
Treatment with any drug or restoration that may include lichenoid reaction.
Patients with other systemic diseases or illnesses will be excluded.
Patient allergic to stated medication will also be excluded
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| appearance of normal mucosa (Score 2 on Thongprasom scale),pain and Burning sensation (VAS 3). |
Baseline, 1 month, 2 months, 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| normal mucosa (Score 0),absence of pain and BS (VAS 0) |
Baseline, 1 month, 2 months, 3 months |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
23/02/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
OBJECTIVES OF THE STUDY-1. Assess the effectiveness of topical Roflumilast 0.3% in the management of
Oral Lichen Planus.
2. To compare the effectiveness of topical Roflumilast 0.3% and triamcinolone
acetonide 0.1% in the management of Oral lichen planus. Source of data
Data will be
collected from patients reporting to the Out-Patient Unit of Oral Medicine and
Radiology in the Faculty of Dental Sciences, I.M.S., B.H.U. Patients fulfilling
the inclusion criteria (stated below) will be selected. Diagnosis of OLP would
be based on the patient’s history, clinical features, and histopathological
confirmation by biopsy Sampling
technique- Simple Randomised Sampling
Sample
size determination- The sample size was estimated using the data
(internal resorption) obtained from a previous study conducted by Zirwas MJ et
al with a=0.05 and power of study 80%, the sample
size calculated was n=32 samples per group. Study design - Randomized control trial with concurrent parallel
design. 1. Diagnosis of patient of Oral Lichen Planus
will be made clinically as well as histologically. Pain will be recorded using
VAS (Visual Analog Scale) and clinical signs and symptoms will be recorded
using RAE Score used by Thongprasom and co-workers (Reticular, Atrophic,
Ulcerative). 2. An informed consent and treatment to be given will
be explained to the patient before including in either group. 3. Baseline scoring of pain and clinical signs and symptoms will be
recorded. 4. Patients will then be divided randomly into two
groups i.e control group and the experimental group.
5. Patients in the control group will be given
topical corticosteroid (0.1% triamcinolone acetonide), topical application 3 times
daily with no food or fluid intake 1hour after application for 2 weeks.
Follow-up will be done every week but VAS and RAE scoring once a month and at
baseline (i.e baseline,1 month, 2 months, 3 months). 6. Patients of the experimental group will be
treated with topical ROFLUMILAST 0.3% topical application 2 times daily with no
food or fluid intake 1hour after application for 2 weeks. Follow-up will be
done every week but VAS and RAE scoring once a month and at baseline (i.e
baseline,1 month, 2 months, 3 months). 7. VAS and RAE scoring will be done every month and at baseline (i.e
baseline,1month,2months,3 months).
8. Comparative evaluation of VAS and RAE scores will be done.
|