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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  
Name  Address 
NIL   
 
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  
Status 
Not Applicable 
 
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.

 
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