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CTRI Number  CTRI/2024/01/061673 [Registered on: 19/01/2024] Trial Registered Prospectively
Last Modified On: 12/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study on bimatoprost eye solution vs tacrolimus ointment in treatment of stable vitiligo. 
Scientific Title of Study   Comparative study on the therapeutic efficacy of topical bimatoprost (0.03%) ophthalmic solution and tacrolimus (0.1%) ointment in 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  Riya 
Designation  Post Graduate Junior Resident  
Affiliation  Eras Lucknow Medical College and Hospital 
Address  Department of Dermatology, 2nd Floor, Eras Lucknow Medical College and Hospital, Sarfarazganj

Lucknow
UTTAR PRADESH
226003
India 
Phone  7888526511  
Fax    
Email  kalawatriya25@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Kshitij Saxena  
Designation  Professor 
Affiliation  Eras Lucknow Medical College and Hospital 
Address  Department of Dermatology, 2nd Floor, Eras Lucknow Medical College and Hospital, Sarfarazganj

Lucknow
UTTAR PRADESH
226003
India 
Phone  9208015391  
Fax    
Email  drkshitijsaxena@live.com  
 
Details of Contact Person
Public Query
 
Name  Riya 
Designation  Post Graduate Junior Resident  
Affiliation  Eras Lucknow Medical College and Hospital 
Address  Department of Dermatology, 2nd Floor, Eras Lucknow Medical College and Hospital, Sarfarazganj

Lucknow
UTTAR PRADESH
226003
India 
Phone  8872625933  
Fax    
Email  kalawatriya25@gmail.com  
 
Source of Monetary or Material Support  
Eras Lucknow Medical College and Hospital , Lucknow 
 
Primary Sponsor  
Name  Eras Lucknow Medical College and Hospital 
Address  Second floor, Department of Dermatology , Eras Lucknow Medical College and Hospital, Sarfarazganj  
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 
Dr Riya   Eras Lucknow Medical College and Hospital  Room No 2, Second floor, Department of Dermatology, Eras Lucknow Medical College and Hospital
Lucknow
UTTAR PRADESH 
7888526511

kalawatriya25@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Eras Lucknow Medical College and Hospital , Lucknow   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  Bimatoprost (0.03%) Ophthalmic Solution  Prostaglandin Analogue Dose- 0.03% Frequency- Twice Daily Route - Topical application over the lesions Follow up- 4 weeks, 8 weeks and 12 weeks Duration of study - 12 weeks After completion of trial period, treatment of the patient with the drug shall continue if necessary. 
Comparator Agent  Tacrolimus (0.1%) Ointment  Calcineurin inhibitor Dose- 0.1% Frequency- Twice Daily Route - Topical application over the lesions Follow up- 4 weeks, 8 weeks and 12 weeks Duration of study - 12 weeks After completion of trial period, treatment of the patient with the drug shall continue if necessary. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Stable vitiligo patients involving less than 5 % of body surface area attending the dermatology OPD at Era Lucknow Medical College and Hospital  
 
ExclusionCriteria 
Details  1. Vitiligo patients who took treatment in last 3 months
2. Patient having hypersensitivity to tacrolimus ointment and bimatoprost ophthalmic solution.
3. Pregnant and lactating women
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare the therapeutic response of topical bimatoprost (0.03%) ophthalmic solution with tacrolimus (0.1%) ointment in cases of stable vitiligo.  0,4,8,12 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
1.To study the clinical response of bimatoprost (0.03%) ophthalmic solution on stable vitiligo.
2.To study the clinical response of tacrolimus (0.1%) ointment on stable vitiligo.
3.To identify any adverse effects associated with the use of topical bimatoprost (0.03%) ophthalmic solution and tacrolimus ointment (0.1%) in cases of stable vitiligo.
 
0,4,8,12 weeks  
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   24/01/2024 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

A total of 50 patients presenting to the Department of Dermatology, Eras Lucknow Medical College and Hospital, Lucknow of stable vitiligo i.e. Lack of progression of old lesions within the past 6 months and No new lesions developing within the same period will be approached for participation in the study. Patients meeting the inclusion and exclusion criteria and giving written consent for participating in the study shall be recruited. History and clinical examination with photographic documentation, and VASI (Vitiligo Area Severity Index) score will be done before starting treatment and then at each visit. Patients will be randomly divided into two groups – A and B each containing 25 individuals. In group A – Patients will be advised to apply Bimatoprost (0.03%) ophthalmic solution twice daily over the lesion for 12 weeks. In group B – Patients will be advised to apply tacrolimus (0.1%) ointment twice daily over the lesion for 12 weeks. Patients will be followed up at 4, 8, and 12 weeks and at each follow-up visit clinical response will be determined by the reduction in subjective response and VASI score. Based on the reduction in the subjective response and VASI score the therapeutic efficacy is graded.

If at any point, any patient withdraws the consent or started developing new lesions during the study or does not come for 2 consecutive follow-ups despite telephonic reminder. He/She shall be considered dropped out of the study.

 
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