| CTRI Number |
CTRI/2026/03/106939 [Registered on: 27/03/2026] Trial Registered Prospectively |
| Last Modified On: |
25/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Medical Device |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study to compare the effects of topical tofacitinib 2% ointment alone with the effects of combination of topical tofacitinib 2% ointment and excimer laser in the treatment of stable vitiligo |
|
Scientific Title of Study
|
A COMPARATIVE STUDY ON THE
THERAPEUTIC EFFICACY OF TOPICAL TOFACITINIB 2 PERCENT OINTMENT WITH EXCIMER LASER 308nm VERSUS TOPICAL TOFACITINIB 2 PERCENT OINTMENT MONOTHERAPY IN STABLE |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SHREYA PODDAR |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Eras Lucknow Medical College And Hospital |
| Address |
Department of dermatology
Eras Lucknow Medical College and Hospital Sarfarazganj Lucknow, Uttar pradesh 226003 India
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9038917453 |
| Fax |
|
| Email |
drshreyapo@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Savita Chaudhary |
| Designation |
consultant and Head of Department. |
| Affiliation |
Eras Lucknow Medical College And Hospital |
| Address |
Department of dermatology
Eras Lucknow Medical College and Hospital Sarfarazganj Lucknow, Uttar pradesh 226003 India
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
7839316909 |
| Fax |
|
| Email |
Savitagarg3@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SHREYA PODDAR |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Eras Lucknow Medical College And Hospital |
| Address |
Department of dermatology
Eras Lucknow Medical College and Hospital Sarfarazganj Lucknow, Uttar pradesh 226003 India
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9038917453 |
| Fax |
|
| Email |
drshreyapo@gmail.com |
|
|
Source of Monetary or Material Support
|
| Eras Lucknow Medical College and Hospital , Lucknow, Uttar Pradesh. 226003.
India. |
|
|
Primary Sponsor
|
| Name |
ERAS LUCKNOW MEDICAL COLLEGE |
| Address |
DEPARTMENT OF DERMATOLOGY
ERAS LUCKNOW MEDICAL COLLEGE AND HOSPITAL,SARFARAZGANJ,
LUCKNOW 226006. |
| Type of Sponsor |
Private medical college |
|
|
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 Shreya Poddar |
Eras Lucknow Medical College and Hospital , Lucknow |
Room 3,Second floor, Department of Dermatology , Eras Lucknow Medical
College and Hospital, Sarfarazganj
Lucknow
UTTAR PRADESH |
9038917453
drsheyapo@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Eras Lucknow Medical College and Hospital , Lucknow |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L80||Vitiligo, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
tofacitinib 0.2% ointment
plus excimer (308nm) laser |
tofacitinib 0.2% ointment
Frequency- Twice Daily
Route - Topical application over
the lesions with excimer 308nm laser twice weekly over lesions.
Follow up- 4 weeks,
8 weeks 12 weeks and 16 weeks Duration
of study - 16 weeks After
completion of trial period,
treatment of the patient with the
drug shall continue if necessary |
| Comparator Agent |
tofacitinib 0.2% ointment only |
Tofacitinib 0.2% ointment Frequency- Twice Daily Route - Topical application over the lesions over lesions. Follow up- 4 weeks, 8 weeks 12 weeks and 16 weeks Duration of study - 16 weeks After completion of trial period, treatment of the patient with the drug shall continue if necessary |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Stable vitiligo patients aged between 18 and 80, of either gender with clinical diagnosis of stable vitiligo Involving less than 5% of body surface area, attending the Dermatology OPD at ELMC&H.
|
|
| ExclusionCriteria |
| Details |
Vitiligo patients who took treatment in last 3 months.
Patient having hypersensitivity to topical tofacitinib (2%) ointment.
History of photosensitivity disorders or contraindications to phototherapy.
History of intolerance to Excimer (308nm) light.
Pregnant and lactating women. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the efficacy of topical tofacitinib (2%) ointment combined with excimer laser (308nm) therapy, with topical tofacitinib (2%) ointment
monotherapy, in achieving repigmentation in patients with stable vitiligo. |
0,4,8,12,16 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To identify any adverse effects with use of topical tofacitinib (2%) ointment,
excimer laser (308nm) and their combination in stable vitiligo. |
0,4,8,12,16 weeks. |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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)
|
06/04/2026 |
| 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
|
A total of 52 patients with stable vitiligo fulfilling inclusion criteria will be enrolled in our study. Study design: Randomized comparative prospective study. Place of study: Department of Dermatology, ERA’s Lucknow Medical College & Hospital, Lucknow, India. Sample size: 52 patients (26 patients in each group) Study period: 24 months Method of sampling: Simple Random Sampling. STUDY DESIGN: Randomized comparative prospective study. Written informed consent will be taken from patients prior to participation inthe study.Patients will be randomly divided into two groups – A and B each containing 26 individuals.History and clinical examination with photographic documentation, VASI (Vitiligo Area Severity Index) score and subjective response before starting treatment and then at each visit (4, 8, 12 and 16 weeks).Follow-up visits at 4, 8, 12, 16, 20 and 24 weeks will be conducted and results will be tabulated in respective tables. In one group – Patient will be advised to apply topical tofacitinib (2%) ointment twice daily AND undergo excimer laser (308nm) therapy twice a week over the lesion for a duration of 12 weeks. In another group – Patient will be advised to apply topical tofacitinib (2%) ointment alone, twice daily over the lesion for a duration of 12 weeks.Patients will be assessed at baseline then followed up at 4, 8, 12 and 16 weeks and at each follow up visit clinical response will be determined by the reduction in VASI score and Subjective response. Based on the reduction in the VASI score and Subjective response the therapeutic efficacy is graded. Assessment will be done at baseline , 0, 4 8 12, 16 weeks. |