| CTRI Number |
CTRI/2024/02/062184 [Registered on: 01/02/2024] Trial Registered Prospectively |
| Last Modified On: |
24/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
comparing the productiveness of two different ointments in treating oral erosive lichen planus |
|
Scientific Title of Study
|
Comparative efficacy of mycophenolate mofetil and clobetasol propionate for the treatment of oral erosive lichen planus |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Peetha Krupavathi |
| Designation |
Post graduate |
| Affiliation |
SIBAR institute of dental sciences |
| Address |
Room no 1
Department of oral medicine and radiology
Sibar institute of dental sciences
Takkellapadu
Guntur
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
6305579763 |
| Fax |
|
| Email |
krupavathi1912@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sethu Manjusha |
| Designation |
Senior lecturer |
| Affiliation |
Sibar institute of dental sciences |
| Address |
Room no 1
Department of oral medicine and radiology
Sibar institute of dental sciences
Takkellapadu
Guntur
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9963428526 |
| Fax |
|
| Email |
drsethuphanindra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sethu Manjusha |
| Designation |
Senior lecturer |
| Affiliation |
Sibar institute of dental sciences |
| Address |
Room no 1
Department of oral medicine and radiology
Sibar institute of dental sciences
Takkellapadu
Guntur
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9963428526 |
| Fax |
|
| Email |
drsethuphanindra@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sibar Institute of Dental Sciences
Takkellapadu
Guntur
Andhra Pradesh-5220509 |
|
|
Primary Sponsor
|
| Name |
Dr L Krishna Prasad |
| Address |
Sibar Institute of dental sciences,takkellapadu,guntur,andhra pradesh |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Peetha Krupavathi |
SIBAR institute of dental sciences |
room no 1, department of oral medicine and radiology
sibar institute of dental sciences,takkellapadu
Guntur
ANDHRA PRADESH |
6305579763
krupavathi1912@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC SIBAR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Drug efficiency and VAS score of 2 % Topical mycophenolate mofetil and 0.05% clobetasol propionate |
first day followed by 2nd,3rd and 4th week from the first visit |
| Comparator Agent |
VAS score and remission of lesion |
first day followed by 2nd ,3rd and 4th week from the first visit and sufficient amount of each ointment is applied thrice daily for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects clinically diagnosed with oral erosive lichen planus.
|
|
| ExclusionCriteria |
| Details |
1.Lichen planus associated with amalgam restorations.
2.Asymptomatic oral lichen planus.
3.Subjects with uncontrolled diabetes.
4.Subjects with pregnancy and lactating mothers
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Efficacy of 2% topical mycophenolate mofetil ointment
2.Efficacy of 0.05% clobetasol ointment
3.Comparative efficacy of both the ointments
|
first day and 2nd,3rd,4th week from the first visit |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.VAS score of both the ointments
2.comparison pf both the ointments in case of remission of lesion |
first day and 2nd,3rd,4th week from the first visit |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
06/02/2024 |
| 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="0"
Months="8"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 31-01-2024 and end date provided 31-08-2024?
Response (Others) -
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
20 subjects, referred to the Department of Oral Medicine will be evaluated by the investigator based on modified WHO criteria for erosive oral lichen planus (OLP)diagnosis (Van der Meij & Van der Waal, 2003), will be included. 10 patients with bilateral OLP receiving mycophenolate mofetil will be included in Group A and 10 patients with OLP receiving clobetasol will be included in (Group B).In Group A, the patients will be instructed to place 2% Mycophenolate mofetil (MMF) mucoadhesive on lesions Thrice daily (morning, afternoon and at night) after taking food, for 4 weeks(first visit,2nd week,3rd week and fourth week from first day). Neither patients nor investigator will be aware of which medication is being administered. In Group B, the patients will be using 0.05% Clobetasol propionate on the lesion thrice daily (morning and afternoon, night), for 4 weeks (first visit,2nd week,3rd week and fourth week from first day). All the patients will be instructed to breathe through the mouth before drug use to make the surface dry and then place the mucoadhesive on the lesion and wait for 1 min for its attachment. The patients will be asked to avoid eating, drinking and mouth washing for at least 10–15 min. They are also asked about drug compliance and side effects of gastrointestinal system, rash, fever, and headache each week(4 visits) and by phone calls between weekly visits.On every first visit,VAS score and reduction of lesion size will be recorded and data will be analysed and compared to assess the efficacy of both the topical ointments and also to compare the efficacy of both the ointments by using statistical tests.
|