| 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
|
|
|
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
|
|
|
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. |