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CTRI Number  CTRI/2025/11/096891 [Registered on: 04/11/2025] Trial Registered Prospectively
Last Modified On: 03/11/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Laser-assisted topical drug delivery]  
Study Design  Other 
Public Title of Study   Study comparing two treatment methods using lasers and tofacitinib to improve skin color in vitiligo on hands and feet. 
Scientific Title of Study   Comparative Efficacy of CO2 Laser-Assisted Topical Tofacitinib Delivery Combined with Excimer Laser Versus Topical Tofacitinib with Excimer Laser for Acral Vitiligo: A Randomized, Intraindividual Trial. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
CACS-DS (25-26)-007, version:1, dated 03 oct 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  NA 
Address  NA 
Type of Sponsor  Other [NA] 
 
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 Prateek Nayak  CUTIS Academy of Cutaneous Sciences  5/1, 4th Main, MRCR Layout, Vijayanagar
Bangalore
KARNATAKA 		 9561509166

nayakprateek@rocketmail.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  Fractional CO2 laser–assisted topical tofacitinib (2 percent ointment) combined with 308 nm excimer laser therapy  CO2 laser: DEEP FX mode, 17.5–22.5 J/cm2, 10 percent density, 300 Hz, 3 sessions (4 weeks apart) Topical tofacitinib applied immediately post-laser under occlusion for 30 minutes, then twice daily Excimer laser twice weekly for 24 weeks (dose escalation from 100–200 mJ/cm2 up to 1,000 mJ/cm2) 
Comparator Agent  Topical tofacitinib (2 percent ointment) with excimer laser  Topical tofacitinib 2 percent ointment will be applied twice daily over the affected acral vitiligo lesions. Excimer therapy (308 nm) will be administered twice weekly for 24 weeks, with dose escalation from 100–200 mJ/cm2 up to a maximum of 1,000 mJ/cm2 based on patient tolerance and response 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Phototherapy naïve adults aged 18–50 years with clinically diagnosed acral vitiligo (affecting hands and/or feet).
2. Stable vitiligo for at least 6 months prior to enrolment, defined by no new lesions or expansion of existing lesions.
3. Vitiligo Disease Activity (VIDA) score of 0–1, indicating stable or minimally active disease.
4. Symmetric or comparable bilateral acral lesions suitable for intraindividual comparison
5. Willingness to comply with study procedures and avoid other vitiligo treatments during the trial. 
 
ExclusionCriteria 
Details  1. Active or progressive vitiligo (VIDA score greater than 1).
2. History of hypersensitivity to tofacitinib, 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, 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 
Proportion of target acral vitiligo lesions achieving 50 percent or more repigmentation at week 24, assessed by standardized digital planimetry with blinded evaluation.  After 24 Week 
 
Secondary Outcome  
Outcome  TimePoints 
Proportion of lesions with 75 percent and 90 percent or more repigmentation, mean percentage improvement in TL VESplus score, time to onset of 10 percent repigmentation, physician and patient global assessment of repigmentation, durability of response at week 36 with maintenance of 50 percent repigmentation without 25 percent loss, and incidence of adverse events, pain scores, and local reactions.  After 24 Week 
 
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)   20/11/2025 
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="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   Acral vitiligo is among the most treatment resistant forms of vitiligo, largely due to poor drug penetration, low follicular reservoir, and reduced melanocyte density in acral areas. Phototherapy remains central to vitiligo management, but its effectiveness in acral lesions is limited. Tofacitinib, a JAK inhibitor, provides targeted immune modulation by blocking interferon gamma CXCL10 signaling, thereby reducing T cell mediated melanocyte destruction. Tofacitinib also works synergistically with phototherapy, as light promotes melanocyte regeneration and complements immune suppression. Fractional CO2 laser enhances this approach by creating microchannels that improve drug delivery and by stimulating melanocyte proliferation, migration, and repigmentation through wound healing pathways. Therefore, combining fractional CO2 laser assisted topical tofacitinib delivery with excimer laser phototherapy may improve both drug absorption and pigment restoration, offering a potentially superior treatment option compared to topical tofacitinib with excimer therapy alone for resistant acral vitiligo. 
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