| CTRI Number |
CTRI/2024/06/068808 [Registered on: 12/06/2024] Trial Registered Prospectively |
| Last Modified On: |
11/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study on efficacy of fractional CO2 LASER with topical Latanoprost vs fractional CO2 LASER with topical Tofacitinib in stable vitiligo - An interventional study |
|
Scientific Title of Study
|
A study on efficacy of fractional CO2 LASER with topical Latanoprost vs fractional CO2 LASER with topical Tofacitinib in stable vitiligo - An interventional study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bommaka Sruthi |
| Designation |
Junior Resident |
| Affiliation |
Sri Devaraj Urs Academy of Higher Education and Research |
| Address |
Room no 26, Department of Dermatology, Sri Devaraj Urs Medical College, Tamaka, Kolar, 563101
Kolar
KARNATAKA
563103
India |
| Phone |
8919923874 |
| Fax |
|
| Email |
bommakasruthi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suresh Kumar K |
| Designation |
Associate professor |
| Affiliation |
Sri Devaraj Urs Medical College |
| Address |
Room no 26, Department of Dermatology, Sri Devaraj Urs Medical College, Tamaka , Kolar.
Kolar
KARNATAKA
563103
India |
| Phone |
9535071967 |
| Fax |
|
| Email |
sk5787@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sruthi |
| Designation |
Junior Resident |
| Affiliation |
Sri Devaraj Urs Medical College |
| Address |
Room no 26,Department of Dermatology, Sri Devaraj Urs Medical College, Tamaka, Kolar.
Kolar
KARNATAKA
563103
India |
| Phone |
8919923874 |
| Fax |
|
| Email |
bommakasruthi@gmail.com |
|
|
Source of Monetary or Material Support
|
| RL Jalappa hospital, Sri Devaraj Urs Medical College, Tamaka, Kolar, India, 563103. |
|
|
Primary Sponsor
|
| Name |
Bommaka Sruthi |
| Address |
Department of Dermatology, Sri Devaraj Urs Medical College, Tamaka, Kolar, India, 563103. |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Bommaka Sruthi |
RL Jalappa hospital, Sri Devaraj Urs Medical College. |
Room no 26, Department of Dermatology, Sri Devaraj Urs Medical College, Tamaka, Kolar.
Kolar
KARNATAKA |
8919923874
bommakasruthi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Devaraj urs medical college institutional ethics committee |
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 |
Fractional CO2 LASER with topical latanoprost |
For 8 weeks with interval of 2 weeks and daily topical application of Latanoprost |
| Intervention |
Fractional CO2 LASER with topical Tofacitinib |
For 8 weeks with interval of 2 weeks with daily topical application of Tofacitinib for 8 weeks |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All patients above 6 years of age |
|
| ExclusionCriteria |
| Details |
Patients with keloidal tendency
Pregnant or lactating women
Patients with vitiligo associated syndromes
Patients who are not willing to participate in study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Repigmentation will be assessed using dermoscopy and photographic assessment using MIISP score and GPA score |
Baseline, 4weeks, 8weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Adverse effects of fractional CO2 LASER, Tofacitinib, Latanoprost. |
Before each sitting -every 2 weeks and
At end point of 4 sessions and 2 weeks after last session |
|
|
Target Sample Size
|
Total Sample Size="58"
Sample Size from India="58"
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)
|
30/06/2024 |
| 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="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
This study is to determine the efficacy of fractional CO 2 LASER with topical Latanoprost versus topical Tofacitinib in treatment of stable vitiligo patients, Fractional CO 2 LASER, Fractional CO2 LASER will be done every two weekly once at that time either of the two topical agents according to randomization will be given and patient will be advised to use the same topical agent till completion of 8 weeks. Topical Tofacitinib 2% and Topical Latanoptost are Melanocyte stimulating agents and hence are tried in treatment of vitiligo, as of now no study has compared these groups. Thus making this study first of its kind. |