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CTRI Number  CTRI/2024/04/065773 [Registered on: 16/04/2024] Trial Registered Prospectively
Last Modified On: 08/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Medical Device
Radiation Therapy 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   it is a study involving vitiligo patients, which will be treated by two separate topical medication followed by procedure with microneedling and NBUVB therapy which will result in darkening of vitiligo patches 
Scientific Title of Study   a comparative study of the efficacy of the topical triamcinolone acetonide versus topical latanoprost in combination with microneedling and narrowband ultraviolet B phototherapy in the treatment of vitiligo 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rohan Rathod 
Designation  Junior resident 
Affiliation  MGM institute of health sciences 
Address  OPD number 256. Department of dermatology, MGM Hospital, N6 cidco, aurangabad

Aurangabad
MAHARASHTRA
431003
India 
Phone  8050289982  
Fax    
Email  rohanrathod396@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Aniruddha gulanikar  
Designation  Professor 
Affiliation  Mahatma Gandhi missions institute of health sciences 
Address  skin opd 256 mgm medical college and hospital n6 cidco aurangabad maharashtra

Aurangabad
MAHARASHTRA
431003
India 
Phone  9822377963  
Fax    
Email  agulanikar@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Aniruddha gulanikar  
Designation  Professor 
Affiliation  Mahatma Gandhi Missions institute of health sciences 
Address  skin opd 256, mgm medical college and hospital n6 cidco aurangabad maharashtra

Aurangabad
MAHARASHTRA
431003
India 
Phone  9822377963  
Fax    
Email  agulanikar@hotmail.com  
 
Source of Monetary or Material Support  
MGM medical college and hospital, N6 cidco, Aurangabad, Maharashtra, India, 431003 
 
Primary Sponsor  
Name  mgm medical college and hospital 
Address  MGM medical college and hospital N6 cidco aurangabad 431003 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrRohan Rathod  Mahatma Gandhi missions hospital  opd no 256 department of dermatology mgm hospital N6 cidco Aurangabad maharashtra
Aurangabad
MAHARASHTRA 		 8050289982

rohanrathod396@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MGM MEDICAL COLLEGE ISTITUTIONAL ETHICS COMMITTEE, NAVI MUMBAI   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  L80 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  INJECTION TRIAMCINOLONE ACETONIDE  topical application of injection Triamcinolone acetonide available in solution of 10mg/ml following microneedling every 2 weeks for 3 months and nbuvb therapy every 3 days  
Intervention  Latanoprost ophthalmic solution  topical application of Latanoprost available in 0.005% solution following microneedling every 2 weeks for 3 months and concomitant nbuvb therapy every 3 days for 3 months 
Comparator Agent  not applicable   not applicable 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  A patient who voluntarily agreed and given consent to participate in the study.
A patient who has two or more non segmental, stable vitiligo lesions with similar degree of progression measuring 5cm2 or more present over the face, trunk or limbs.
All patients with vitiligo presenting to MGM medical college and hospital.
 
 
ExclusionCriteria 
Details  Local disease such as folliculitis.
Patient on anticoagulants and blood thinners
Keloidal tendencies
HIV, Hepatitis B or C, or otherwise
immunocompromised patient.
Unrealistic expectations of patients
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Repigmentation of vitiligo patches will be assessed.  patient will be assessed photographically first before intervention and next after 3 months at the end of intervention 
 
Secondary Outcome  
Outcome  TimePoints 
global assessment of repigmentation of vitiligo patches will be done by patients  after completion of intervention i.e 3 months 
 
Target Sample Size   Total Sample Size="21"
Sample Size from India="21" 
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)   15/05/2024 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
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
Modification(s)  

     I.         

There is always a constant need of newer modalities of treatment as the results are variable and unpredictable.

Microneedling had been suggested either singly or concomitantly with other therapeutic modalities for vitiligo with encouraging results.

Although surgical treatments are generally more effective, microneedling has become increasingly popular due to its accessibility and ease of use. Unlike surgical modalities that may require specialized equipment and expertise, microneedling is a minimally invasive procedure that can be performed in a day care set-up.

 
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