| CTRI Number |
CTRI/2024/07/070729 [Registered on: 16/07/2024] Trial Registered Prospectively |
| Last Modified On: |
15/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing Oral Tofacitinib and Topical Triamcinolone Acetonide for Oral Lichen Planus: A Randomized Trial |
|
Scientific Title of Study
|
Oral tofacitinib compared with topical triamcinolone acetonide (0.1 percent) paste in patients with symptomatic oral lichen planus: a randomized controlled trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NA |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Dipankar De |
| Designation |
Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research, Chandigarh |
| Address |
Department of Dermatology, Venereology and Leprology, Postgraduate Institute of Medical Education and Research, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9316123724 |
| Fax |
|
| Email |
dr_dipankar_de@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dipankar De |
| Designation |
Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research, Chandigarh |
| Address |
Department of Dermatology, Venereology and Leprology, Postgraduate Institute of Medical Education and Research, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9316123724 |
| Fax |
|
| Email |
dr_dipankar_de@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dipankar De |
| Designation |
Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research, Chandigarh |
| Address |
Department of Dermatology, Venereology and Leprology, Postgraduate Institute of Medical Education and Research, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9316123724 |
| Fax |
|
| Email |
dr_dipankar_de@yahoo.in |
|
|
Source of Monetary or Material Support
|
| Department of Dermatology, venereology and leprology, Postgraduate Institute of Medical Education and Research, Chandigarh, State: Chandigarh, India.
PIN: 160012 |
|
|
Primary Sponsor
|
| Name |
ostgraduate Institute of Medical Education and Research Chandigarh |
| Address |
Department of Dermatology, Venereology and Leprology, Postgraduate Institute of Medical Education and Research, Chandigarh, Chandigarh, 160012 |
| 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 |
| Dr Dipankar DE |
Postgraduate Institute of Medical Education and Research, Chandigarh |
Room number 5007, Department of Dermatology, Venereology and Leprology, New OPD, State: Chandigarh, 160012
Chandigarh
CHANDIGARH |
09316123724
dr_dipankar_de@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Postgraduate Institute of Medical Education and Research, Chandigarh institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L438||Other lichen planus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Tofacitinib |
Patients in this arm with oral lichen planus will receive oral tablet tofacitinib 5 mg twice daily for a period of 6 months. |
| Comparator Agent |
topical triamcinolone acetonide (0.1%) |
Patients with oral lichen planus in this arm will receive topical triamcinolone acetonide 0.1% paste thrice daily for a period of 6 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Clinician-confirmed diagnosis of symptomatic oral lichen planus having exclusive oral involvement or predominant oral involvement with few cutaneous lesions
2. Patients aged between 18-60 years of age
3. Patients providing informed consent and are willing to follow up monthly for at least 6 months
|
|
| ExclusionCriteria |
| Details |
1. Pregnant and lactating women
2. Women with childbearing potential who are unwilling to follow reliable methods of contraception |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Proportion of patients achieving 75% reduction in Oral Disease Severity Score (ODSS) proposed by Escudier et al at the end of 6 months of therapy
2. Proportion of patients achieving a Thongprasom et al score of 1/2 at the end of 6 months of therapy
|
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Change in pain score based on Visual analogue scale (VAS)
2. Change in oral health-related quality of life based on oral health impact profile 14 score (OHIP-14)
3. Percentage change in the clinical scoring system at the end of 6 months of therapy
|
6 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
31/07/2024 |
| 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="9"
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
|
**Aim:** To evaluate the efficacy and safety of oral tofacitinib in symptomatic oral lichen planus and compare it with topical triamcinolone acetonide 0.1% paste.
**Primary Objective:** - Compare the efficacy of oral tofacitinib with topical triamcinolone acetonide 0.1% paste in treating symptomatic oral lichen planus.
**Secondary Objectives:** 1. Compare the safety profile between the two treatment arms. 2. Compare the change in pain score based on the Visual Analogue Scale (VAS). 3. Compare the change in oral health-related quality of life using the Oral Health Impact Profile 14 score (OHIP-14).
**Primary Outcomes:** 1. Proportion of patients achieving a 75% reduction in the Oral Disease Severity Score (ODSS) at the end of 6 months. 2. Proportion of patients achieving a Thongprasom et al. score of 1/2 at the end of 6 months.
**Secondary Outcomes:** 1. Change in pain score based on VAS. 2. Change in oral health-related quality of life using OHIP-14. 3. Percentage change in the clinical scoring system at the end of 6 months.
**Materials and Methods:**
**Study Period:** January 2024 - December 2025
**Study Design:** Open-label randomized controlled trial.
**Study Setting:** Patients from the outpatient department of the Department of Dermatology, Venereology, and Leprology at PGIMER, Chandigarh, India.
**Sample Size:** 54 patients total, with 30 patients in each arm, accounting for a 10% dropout rate.
**Methodology:** - Ethics approval and trial registration. - 6 months of active treatment followed by 3 months of follow-up. - Detailed history, clinical assessment, and photographic documentation at baseline and every 4 weeks. - Randomization using computer-generated sequences and allocation concealment with SNOSE technique.
**Treatment Regimen:** - **Arm 1:** Oral tofacitinib 5 mg twice daily. - **Arm 2:** Topical triamcinolone acetonide 0.1% paste thrice daily.
**Assessment:** - Monthly clinical assessment using ODSS. - Responses categorized as excellent (≥75% reduction), good (50-74%), poor (25-50%), or no response (<25%).
This study aims to provide comparative data on the effectiveness and safety of oral tofacitinib versus topical triamcinolone in treating symptomatic oral lichen planus, potentially guiding future treatment protocols. |