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CTRI Number  CTRI/2025/04/083785 [Registered on: 01/04/2025] Trial Registered Prospectively
Last Modified On: 27/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Other (Specify) [Dermabrasion followed by application of tacrolimus cream and dinoprostone ointment]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To assess the effectiveness and safety of dermabrasion followed by tacrolimus and dermabrasion followed by dinoprostone in stable vitiligo patients. 
Scientific Title of Study   A comparative study to evaluate the efficacy and safety of dinoprostone and tacrolimus following dermabrasion in the treatment of stable 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  Dr Monika V 
Designation  Postgraduate 
Affiliation  Bangalore medical college and research institute 
Address  Department of dermatology, Bangalore medical college, fort, kr road, kalasipalya, 560002.

Bangalore
KARNATAKA
560002
India 
Phone  9632470190  
Fax    
Email  drmonikavasanth@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shilpa K 
Designation  Professor and head 
Affiliation  Bangalore medical college and research institute 
Address  Department of dermatology, Bangalore medical college, fort, kr road, kalasipalya, 560002.

Bangalore
KARNATAKA
560002
India 
Phone  9886553646  
Fax    
Email  shilpakvinod1980@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shilpa K 
Designation  Professor and head 
Affiliation  Bangalore medical college and research institute 
Address  Department of dermatology, Bangalore medical college, fort, kr road, kalasipalya, 560002.


KARNATAKA
560002
India 
Phone  9886553646  
Fax    
Email  shilpakvinod1980@gmail.com  
 
Source of Monetary or Material Support  
Bangalore medical college and research institute. Fort, Krishna Rajendra road, Kalasipalya, Bengaluru, Karnataska, 560002 
 
Primary Sponsor  
Name  Dr Monika V 
Address  Department of dermatology, Bangalore medical college and research institute, fort, kr road, kalasipalya, 560002 
Type of Sponsor  Government medical college 
 
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 Monika V  Bangalore medical college and research institute.  Department of dermatology, Bangalore medical college and research institute, fort, kr road, kalasipalya, 560002
Bangalore
KARNATAKA 
9632470190

drmonikavasanth@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee , bangalore medical college and research institute  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 
Comparator Agent  Dermabrasion followed by 0.1% tacrolimus ointment.  One session of dermabrasion followed by 0.1% tacrolimus ointment followed by twice daily application of 0.1% tacrolimus ointment for 6 months 
Intervention  Dermabrasion followed by 0.5mg/3g Dinoprostone gel.  One session of dermabrasion followed by 0.5mg/3g dinoprostone gel followed by twice daily application of 0.5mg/3g dinoprostone gel for 6 months  
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Patients willing to give informed consent.
2.Patient of either gender aged more than 15yrs
3.Patients willing for follow up
4. Patients with clinically diagnosed Stable Vitiligo
 
 
ExclusionCriteria 
Details  1.Patient not willing to give informed consent
2.Patients having unstable vitiligo
3.Pregnant and lactating females
4.Patients having keloidal tendency
5.Patients having documented hypersensitivity to lignocaine, tacrolimus and dinoprostone.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Change in vitiligo area severity index (VASI).  Change in vitiligo area severity index (VASI) at: 4,8,12,16,20 and 24 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Safety.  Adverse effects at: 4,8,12,16,20 & 24 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)   04/05/2025 
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  
Dermabrasion is a commonly used surgical modality in the treatment of stable vitiligo. This minimal invasive method can be combined with various topical therapies for better drug penetration hence better results. As vitiligo is proposed to be a result of autoimmunity, topical immunomodulator drugs like Calcineurin inhibitors like pimecrolimus and tacrolimus are used in treatment of vitiligo.  There is increased expression of various Prostaglandin receptors like Prostaglandin E2(PGE2) type1 and 3 over melanocytes. PGE2 analogue like Dinoprostone was used in the treatment of vitiligo in the year 2002. Combination of dermabrasion and topical agents have given better results in few clinical studies. 
                      Here the aim of study is to compare and evaluate Tacrolimus and Dinoprostone following dermabrasion in the treatment of stable vitiligo using VASI (Vitiligo Area Scoring Index) and record adverse effects if any. 
Based on the previous study conducted by Kaur J et al, after 24 weeks, Grade 4 repigmentation in Group A and Group B are 25% and 0% respectively, sample size was calculated and found to be 52. After obtaining approval and clearance from the institutional ethics committee, the patients fulfilling the inclusion criteria will be enrolled for the study after obtaining informed consent. A detailed clinical history will be taken in terms of demographic data, age, sex, occupation, presenting complaints, past history, treatment history, family history duration of skin lesions, course and progression of disease and clinical examination findings will be recorded in the case record form. Appropriate photographs will be taken at each visit with informed consent. After detailed history taking and thorough clinical examination, patients diagnosed with Stable Vitiligo will be allocated into two study groups of 26 each, randomized in 1:1 ratio using computer random sequence generator.
Patients in both groups A and B will be taken up for Dermabrasion and following steps will be done:
·       A desired area of depigmented vitiligo patch is selected.
·       Patch is sterilized using povidine iodine solution.
·       Patch is anesthetized using 2% lignocaine injection.
·       Using Manekshaw’s dermabrader, dermabrasion is done 3-4 times in each direction horizontally, vertically and diagonally until pinpoint bleeding occurs.
·       Hemostasis is achieved and following treatment is given for each group.
a.     Group A patients will be taken up for tacrolimus 0.1% ointment application.
b.     Group B patients will be taken up for Dinoprostone 0.5mg/3g gel application.

 After application of topical creams, dressing is done. Patients are advised to remove dressing after 24 hours and then are advised to apply tacrolimus 0.1% ointment twice daily and Dinoprostone 0.5mg/3g gel twice daily in group A and B respectively. Patients will be given oral analgesics, Tab.Paracetamol 500mg, as needed. This drug does not interfere with the topicals used in the study. Patients will be followed up on Day 3 and Day 7 for assessment of any side effects.  VASI (Vitiligo Area Severity Index) will be assessed at weekly intervals from week 4 to 24 along with simultaneous serial digital photographs and recording of side effects if any.

 
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