| CTRI Number |
CTRI/2024/11/076203 [Registered on: 04/11/2024] Trial Registered Prospectively |
| Last Modified On: |
24/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparing pigmentation response in patients of Vitiligo post intervention by creating micro trauma to the affected skin followed by application of 5-Fluorouracil cream or Tacrolimus cream |
|
Scientific Title of Study
|
Comparing efficacy of microneedling with topical 5-Fluorouracil Vs microneedling with topical Tacrolimus in 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 |
Avinash Sai |
| Designation |
Resident Dermatology |
| Affiliation |
Base Hospital Delhi Cantonment |
| Address |
Department of dermatology, Base hospital delhi cantt, cantonment, New Delhi
South West
DELHI
110010
India |
| Phone |
9013634325 |
| Fax |
|
| Email |
avinash.sai@outlook.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Shailendra Srivastava |
| Designation |
Senior Advisor and Head of Department |
| Affiliation |
Base Hospital Delhi Cantonment |
| Address |
Department of dermatology, Base hospital delhi cantt, cantonment, New Delhi
South West
DELHI
110010
India |
| Phone |
7023777714 |
| Fax |
|
| Email |
shail951504@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Avinash Sai |
| Designation |
Resident Dermatology |
| Affiliation |
Base Hospital Delhi Cantonment |
| Address |
Department of dermatology, Base hospital delhi cantt, cantonment, New Delhi
DELHI
110010
India |
| Phone |
9013634325 |
| Fax |
|
| Email |
avinash.sai@outlook.in |
|
|
Source of Monetary or Material Support
|
| Commandant, Base hospital delhi cantt, HQ Delhi Area, IHQ MoD Army, Govt Of India |
|
|
Primary Sponsor
|
| Name |
Commandant, Base hospital delhi cantt |
| Address |
for Oic Academic section, Base hospital Delhi Cantt, Cantonment, New Delhi |
| Type of Sponsor |
Government 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 Avinash |
Base Hospital Delhi Cantt |
Room 12, Department of Dermatology, BHDC cantonment, New delhi
South West
DELHI |
9013634325
avinash.sai@outlook.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Base Hospital & Army College of Medical Sciences Delhi Cantt |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
microneedling with topical 0.1% Tacrolimus cream |
microneedling creates minute pores into dermis of skin and 0.1% Tacrolimus is macrolide calcineurin inhibitor which will decrease activity of T-lymphocyte cells. Microneedling with dermaroller will be done once a month for 3 months and cream applied daily at night for 3 months. |
| Intervention |
microneedling with topical 5 % Fluorouracil cream |
microneedling creates minute pores into dermis of skin and 5% Fluorouracil cream is a thymidylate synthetase inhibitor required during DNA replication. loss of DNA replication will inhibit T-lymphocyte function. Microneedling with dermaroller will be done once a month for 3 months and cream applied daily at night for 3 months. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
All patients of stable vitiligo visiting department of dermatology, Base hospital Delhi cantt. |
|
| ExclusionCriteria |
| Details |
Pregnant women.
Age below 6 years and above 70 years.
Lesions over perioral, periocular, patches on the mucosal membrane.
Positive Koebner phenomenon.
Patients with other autoimmune comorbidities.
Patients with coagulation diseases or receiving anticoagulants.
Chronic viral infections of HIV, HBV, HCV.
High risk of keloid or hypersensitivity to the studied drug |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the intensity of re – pigmentation following intervention.
|
every month till 3 months & follow up further 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To measure the rate of re – pigmentation in previously depigmented skin lesions. |
every month till 3 months & follow up further 3 months |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
15/11/2024 |
| 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)
|
Closed to Recruitment of Participants |
| 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
|
To compare the efficacy of microneedling followed by topical 5 Fluorouracil vs microneedling with topical Tacrolimus in improving intensity and area of pigmentation in patients of Vitiligo. All patients of stable vitiligo meeting and inclusion and exclusion criteria will be offered this treatment which will be participant blinded. patients VASI score initially and at each subsequent visit uptill 3 months of follow up following intervention.
|