| CTRI Number |
CTRI/2025/10/096624 [Registered on: 29/10/2025] Trial Registered Prospectively |
| Last Modified On: |
28/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing two oral medicines, tofacitinib and cyclosporine, for treating people with long-lasting itching and understanding how these medicines affect the immune system |
|
Scientific Title of Study
|
Efficacy and safety of oral tofacitinib compared to cyclosporine in prurigo nodularis: A Randomized Controlled Study with assessment of STAT1, STAT3, and STAT6 expression |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Logamoorthy R |
| Designation |
Assistant Professor |
| Affiliation |
Sri Manakula Vinayagar Medical College and Hospital, Puducherry |
| Address |
Room no 70, Department of Dermatology, Sri Manakula Vinayagar Medical College and Hospial, Madagadipet, Kalitheerthalkuppam, Puducherry
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9629033785 |
| Fax |
|
| Email |
logamoorthy.r@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Logamoorthy R |
| Designation |
Assistant Professor |
| Affiliation |
Sri Manakula Vinayagar Medical College and Hospital, Puducherry |
| Address |
Room no 70, Department of Dermatology, Sri Manakula Vinayagar Medical College and Hospial, Madagadipet, Kalitheerthalkuppam, Puducherry
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9629033785 |
| Fax |
|
| Email |
logamoorthy.r@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Logamoorthy R |
| Designation |
Assistant Professor |
| Affiliation |
Sri Manakula Vinayagar Medical College and Hospital, Puducherry |
| Address |
Room no 70, Department of Dermatology, Sri Manakula Vinayagar Medical College and Hospial, Madagadipet, Kalitheerthalkuppam, Puducherry
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9629033785 |
| Fax |
|
| Email |
logamoorthy.r@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Association of Dermatologists, Venereologists, and Leprologists |
|
|
Primary Sponsor
|
| Name |
Indian Association of Dermatologists, Venereologists, and Leprologists |
| Address |
H 3, KM Trade Tower, IADVL National Headquarters 314-315, 3rd Floor, Sector 14, Kaushambi, Ghaziabad, Uttar Pradesh 201010 |
| Type of Sponsor |
Other [Indian Association of Dermatologists, Venereologists, and Leprologists] |
|
|
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 |
| Logamoorthy R |
Sri Manakula Vinayagar Medical College and Hospital |
Room No 70, Department of Dermatology, Madagadipet, Kalitheerthalkuppam, Puducherry 605107
Pondicherry
PONDICHERRY |
9629033785
logamoorthy.r@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMVMCH |
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 |
| Comparator Agent |
oral tablet Cyclopsorine |
oral tablet cyclosporine 100mg morning and night before food for 12 weeks |
| Intervention |
oral tablet Tofacitinib |
oral tablet Tofacitinib 5mg morning and night after food for 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Clinically diagnosed cases of moderate to severe prurigo nodularis |
|
| ExclusionCriteria |
| Details |
1. Immunosuppressed patients
2. Pregnant and Lactating women
3. Contraindications for tofacitinib
4. Contraindications for cyclosporine
5. Not consenting for the study
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy of oral tofacitinib in comparison with cyclosporine (using pruritus grading system score and peak pruritus numerical rating scale) in the management of prurigo nodularis |
4,8 and 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To compare the side effect profile between two groups.
2. To do the cost-effectiveness analysis between the 2 groups.
3. To analyze the tissue expression levels of STAT1, STAT3, and STAT6 in all patients with prurigo nodularis through immunohistochemistry markers.
|
4,8 and 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="58"
Sample Size from India="58"
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)
|
30/11/2025 |
| 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 - 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 who provide a methodologically sound proposal.
- 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) - Data wiil be availabe with the principal investigator proposals should be directed to email: logamoorthy.r@gmail.com
- For how long will this data be available start date provided 22-11-2026 and end date provided 22-11-2031?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Prurigo nodularis (PN), also known as Hydes prurigo, is a chronic pruritic dermatosis characterized by symmetrically distributed hyperkeratotic papules and nodules predominantly over the extremities. The immunopathogenesis of PN involves a complex interplay between Th1, Th2, Th17, and Th22 pathways, along with neuronal and fibroblastic dysregulation. Signal transducer and activator of transcription (STAT) proteins are critical mediators of the Janus kinase (JAK)/STAT signaling cascade, regulating cytokine-induced immune responses. STAT1 and STAT4 are associated with Th1, STAT3 and STAT5 with Th17, and STAT5 and STAT6 with Th2 differentiation. Elevated cytokines such as IL4, IL13, IL17, IL22, and IL31 exert their downstream effects through the JAK/STAT pathway. Previous studies have demonstrated predominant activation of STAT3 and STAT6, suggesting Th2/Th17 predominance in PN pathogenesis.This randomized controlled study aims to compare the efficacy and safety of oral tofacitinib, a JAK1/JAK3 inhibitor, with cyclosporine, a calcineurin inhibitor, in the management of prurigo nodularis. Additionally, it aims to assess the tissue expression of STAT1, STAT3, and STAT6 before and after treatment to elucidate their role in disease modulation. The study seeks to bridge the gap between immunopathogenesis and therapeutics, contributing to optimized systemic management strategies for refractory prurigo nodularis. |