| CTRI Number |
CTRI/2024/11/076876 [Registered on: 18/11/2024] Trial Registered Prospectively |
| Last Modified On: |
15/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Oral tofacitinib in the treatment of nail lichen planus |
|
Scientific Title of Study
|
Efficacy of oral tofacitinib in the treatment of nail lichen planus: a pilot clinical 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 |
Dr Somesh Gupta |
| Designation |
Professor |
| Affiliation |
All India Institute Of Medical Sciences |
| Address |
Department of
dermatology and
venereology, fourth floor,
teaching block, Ansari
Nagar New Delhi Delhi
110029
New Delhi
DELHI
South
DELHI
110029
India |
| Phone |
9868899120 |
| Fax |
|
| Email |
someshgupta@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Somesh Gupta |
| Designation |
Professor |
| Affiliation |
All India Institute Of Medical Sciences |
| Address |
Department of
dermatology and
venereology, fourth floor,
teaching block, Ansari
Nagar New Delhi Delhi
110029
New Delhi
DELHI
South
DELHI
110029
India |
| Phone |
9868899120 |
| Fax |
|
| Email |
someshgupta@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Somesh Gupta |
| Designation |
Professor |
| Affiliation |
All India Institute Of Medical Sciences |
| Address |
Department of
dermatology and
venereology, fourth floor,
teaching block, Ansari
Nagar New Delhi Delhi
110029
New Delhi
DELHI
South
DELHI
110029
India |
| Phone |
9868899120 |
| Fax |
|
| Email |
someshgupta@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Dermatology and venereology, All India Institute of Medical Sciences,
Ansari Nagar, New Delhi
PIN 110029, India |
|
|
Primary Sponsor
|
| Name |
All India Institute Of Medical Sciences |
| Address |
Department of Dermatology and venereology, All India Institute of Medical Sciences, Ansari Nagar, New Delhi PIN 110029, India |
| 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 Somesh Gupta |
All India Institute of Medical Sciences New delhi |
Department of
dermatology and
venereology, fourth floor,
teaching block Ansari
Nagar New Delhi
110049
New Delhi
South
DELHI |
9868899120
someshgupta@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, All India Institute of Medical Sciences, Old OT block, Room No.102, AIIMS Hospital, Ansari Nagar, New Delhi 110029, India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L608||Other nail disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Tofacitinib |
Oral tofacitinib 5 mg twice daily for 6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients with nail lichen planus involving more than 3 nails with or without skin, hair and mucosa involvement |
|
| ExclusionCriteria |
| Details |
1. Anonychia of all 20 nails
2. Pregnant and lactating females
3. Patients with known contra-indications to oral tofacitinib
4. Patients with known cardiovascular disease or venous thromboembolism
5. Patients on topical treatment for last 2 weeks, systemic treatment for last 4 weeks
6. Current or history of malignancy
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of patients with clinical improvement of nail lichen planus after treatment |
3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 Change in mean NALSI after treatment
2. Change in mean DLQI after treatment
|
3 months and 6 months |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
20/01/2025 |
| 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="2"
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
|
Nail lichen planus is a chronic inflammatory disease of unknown etiology, recognized as potentially critical nail disease due to irreversible scarring. It significantly affects patient’s quality of life due to pain and cosmetic disfigurement. Intralesional and intramuscular triamcinolone acetonide injection are considered first line therapies in moderate to severe cases whereas, oral retinoids and immunosuppressive agents are used as second line choices. However, these treatment modalities are associated with high rates of therapeutic failures and relapses, and not suitable for all patients. Current treatment options are limited and depend on the progression of disease. Janus kinase inhibitors, which target inflammatory skin diseases, can suppress both type 1 and type 2 cytokines, reducing the immune response and inflammation. Recent studies have shown benefits of oral JAK inhibitors in treating cutaneous lichen planus and lichen planopilaris. For nail lichen planus, there are few case reports available with beneficial effect. Therefore, our study aims to find out the effectiveness of oral tofacitinib in the treatment of nail lichen planus. |