| CTRI Number |
CTRI/2025/12/098324 [Registered on: 02/12/2025] Trial Registered Prospectively |
| Last Modified On: |
10/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Study comparing ruxolitinib and tacrolimus creams delivered with laser for treating localized vitiligo. |
|
Scientific Title of Study
|
Fractional CO2 Laser facilitated delivery of topical immunomodulators for treatment of localized vitiligo - Ruxolitinib versus Tacrolimus: A Randomized, Intraindividual Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CACS-PD (25-26)-015, Version:1, Dated 26 Sep 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Madura C |
| Designation |
Medical Director and Chief Hair transplant Dermatosurgeon |
| Affiliation |
CUTIS Academy of Cutaneous Sciences |
| Address |
Room No:10 Department of Dermatology
5/1, 4th Main, MRCR Layout, Vijayanagar Bangalore KARNATAKA 560040 India |
| Phone |
9632741998 |
| Fax |
|
| Email |
maduradr@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Madura C |
| Designation |
Medical Director and Chief Hair transplant Dermatosurgeon |
| Affiliation |
CUTIS Academy of Cutaneous Sciences |
| Address |
Room No:10 Department of Dermatology
5/1, 4th Main, MRCR Layout, Vijayanagar
KARNATAKA 560040 India |
| Phone |
9632741998 |
| Fax |
|
| Email |
maduradr@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Madura C |
| Designation |
Medical Director and Chief Hair transplant Dermatosurgeon |
| Affiliation |
CUTIS Academy of Cutaneous Sciences |
| Address |
Room No:10 Department of Dermatology
5/1, 4th Main, MRCR Layout, Vijayanagar
KARNATAKA 560040 India |
| Phone |
9632741998 |
| Fax |
|
| Email |
maduradr@gmail.com |
|
|
Source of Monetary or Material Support
|
| CUTIS Academy of Cutaneous Sciences 5/1,4th Main, MRCR Layout, Vijayanagar, Bangalore 560040 |
|
|
Primary Sponsor
|
| Name |
CUTIS Academy of Cutaneous Sciences |
| Address |
5/1,4th Main, MRCR Layout, Vijayanagar, Bangalore 560040 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 TANVI PATIL |
CUTIS Academy of Cutaneous Sciences |
Room No:10
Department of Dermatology
5/1,4th Main MRCR Layout Vijayanagar Bangalore KARNATAKA |
7798232430
dr.tanvipatil96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CUTIS INSTITUTIONAL ETHICS COMMITTEE |
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 |
CO2 laser + Ruxolitinib |
Selected vitiligo lesions will receive Topical Ruxolitinib 1.5percentage cream will be applied followed by fractional CO2 laser at 4W 800 spacing HP mode shaped to the lesion and extended 0.5 cm beyond margins |
| Comparator Agent |
CO2 laser + Tacrolimus |
Selected vitiligo lesions will receive topical Toplap Cream lidocaine 2.5 percentage and prilocaine 2.5 percentage for 40 minutes followed by fractional CO2 laser at 4W 800 spacing HP mode shaped to the lesion and extended 0.5 cm beyond margins |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients 12 to 60 years of age having at least two comparable or symmetric or lesions suitable for intraindividual comparison vitiligo lesions.
2. Patients with localized vitiligo less than10% body surface area.
3. Stable vitiligo for at least 6 months prior to enrolment, defined by no new lesions or expansion of existing lesions.
4. Vitiligo Disease Activity score of 0–1, indicating stable or minimally active disease.
5. Patients who have not been on any biologic drug for 12 weeks, no phototherapy within 8 weeks, no immunomodulating treatment within 4 weeks and no topical treatments within 1 week.
6. Willingness to comply with study procedures and avoid other vitiligo treatments during the trial. |
|
| ExclusionCriteria |
| Details |
1. Active or progressive vitiligo (VIDA score greater 1).
2. History of hypersensitivity to tacrolimus, laser therapy or excimer light.
3. Concomitant skin conditions (e.g., psoriasis, eczema) that could interfere with assessments.
4. Systemic immunosuppressive therapy within 4 weeks or topical treatments (including JAK inhibitor) within 4 weeks prior to enrolment.
5. Comorbidities such as active infection, malignancy, history of thromboembolic episodes, past or present smoker or severe hepatic/renal impairment.
6. Pregnancy, lactation or inadequate contraception in women of childbearing potential |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Global response in repigmentation, assessed using:
Physician Global Assessment of Repigmentation (PhGA-R)
Patient Global Assessment of Repigmentation (PtGA-R)
Assessment Timeline: Week 8 and Week 16 |
After week 16 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Patient satisfaction measured by Vitiligo Noticeability Scale (VNS) at Week 8 and Week 16
Time to onset of repigmentation, defined as gtreaterthen or equal 10% repigmentation of target lesions confirmed on two consecutive assessments
Durability of repigmentation, including maintenance of response and relapse rates at Week 24 (8 weeks post-treatment) |
After week 16 |
|
|
Target Sample Size
|
Total Sample Size="10" Sample Size from India="10"
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)
|
18/12/2025 |
| 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="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Vitiligo is a chronic autoimmune dermatological
disorder characterized by the selective destruction of melanocytes, resulting
in depigmented macules and patches on the skin and mucous membranes. The
pathogenesis involves a complex interplay of genetic susceptibility,
environmental triggers, oxidative stress, and immune-mediated mechanisms,
including T-cell infiltration and cytokine dysregulation, particularly
involving the JAK-STAT pathway.This leads to progressive loss of pigmentation,
often with a significant psychosocial impact due to aesthetic concerns and
associated stigma.
Vitiligo is classified into several types based
on clinical presentation. Non-segmental vitiligo (NSV), the most common form,
is bilateral and symmetrical, encompassing subtypes such as generalized,
acrofacial, and universal vitiligo. Segmental vitiligo, in contrast, is
unilateral and follows a dermatomal distribution, often stabilizing early.
Other variants include focal and mucosal types, with the disease categorized by
activity as stable (no progression for at least one year) or
active/progressive.
Epidemiologically, vitiligo affects
approximately 0.5-1% of the global population, with prevalence varying
regionally. A 2024 meta-analysis estimated a pooled prevalence of 0.5% among
adults, with higher rates in South Asia, including India, where genetic and
environmental factors may contribute to a prevalence of up to 2-3%. Incidence
rates range from 0.2-0.4 per 1,000 person-years, with onset typically between
10-30 years.
Current treatment options aim to stabilize
disease progression and promote repigmentation. Medical therapies include
topical corticosteroids, calcineurin inhibitors (e.g., tacrolimus 0.1%), and
JAK inhibitors (e.g., ruxolitinib 1.5% cream), with the latter showing efficacy
in NSV through phase III trials. Phototherapies like narrowband UVB
(NB-UVB) and excimer laser (308 nm) are effective for widespread cases,
achieving 50-75% repigmentation. Surgical options, such as
autologous grafting, are reserved for stable vitiligo, yielding over 70%
repigmentation.
Due to variable response to monotherapy,
combination therapies are increasingly utilized. Common regimens include NB-UVB
with tacrolimus or ruxolitinib, enhancing repigmentation through synergistic
effects.[9][6] Fractional CO2 laser-assisted drug delivery (LADD)
with phototherapy improves topical penetration, showing promise in resistant
cases.
This study investigates the comparative
efficacy of CO2 laser-assisted delivery of tacrolimus versus ruxolitinib, both
combined with excimer laser, to optimize treatment for recalcitrant vitiligo in
a diverse population. |