| CTRI Number |
CTRI/2023/07/055803 [Registered on: 28/07/2023] Trial Registered Prospectively |
| Last Modified On: |
26/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
To compare the effectiveness of needling with 5-fluorouracil 5% cream versus topical 88% phenol application in the treatment of vitiligo |
|
Scientific Title of Study
|
Prospective randomized comparative study of therapeutic efficacy of microneedling with 5-fluorouracil 5% cream versus topical 88% phenol application in the treatment of 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. V SIVASUBRAMANIAN |
| Designation |
PROFESSOR AND HEAD OF DEPARTMENT |
| Affiliation |
VINAYAKA MISSIONS MEDICAL COLLEGE, KARAIKAL |
| Address |
DEPARTMENT OF
DERMATOLOGY, VENEREOLOGY AND LEPROSY, VINAYAKA MISSIONS MEDICAL COLLEGE, KARAIKAL
Karaikal
PONDICHERRY
609609
India |
| Phone |
9884835199 |
| Fax |
|
| Email |
hoddvdvmmckkl@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. V SIVASUBRAMANIAN |
| Designation |
HEAD OF DEPARTMENT |
| Affiliation |
VINAYAKA MISSIONS MEDICAL COLLEGE, KARAIKAL |
| Address |
DEPARTMENT OF
DERMATOLOGY, VENEREOLOGY AND LEPROSY, VINAYAKA MISSIONS MEDICAL COLLEGE, KARAIKAL
Karaikal
PONDICHERRY
609609
India |
| Phone |
9884835199 |
| Fax |
|
| Email |
hoddvdvmmckkl@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. VISMITHA S E |
| Designation |
POSTGRADUATE |
| Affiliation |
VINAYAKA MISSIONS MEDICAL COLLEGE, KARAIKAL |
| Address |
DEPARTMENT OF
DERMATOLOGY, VENEREOLOGY AND LEPROSY, VINAYAKA MISSIONS MEDICAL COLLEGE, KARAIKAL
Karaikal
PONDICHERRY
609609
India |
| Phone |
8105987906 |
| Fax |
|
| Email |
sevismitha17@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vinayaka Missions research foundation |
|
|
Primary Sponsor
|
| Name |
Vinayaka Missions Medical College |
| Address |
Keezhakasakudymedu, Karaikal,
Pondicherry |
| 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 V SIVASUBRAMANIAN |
VINAYAKA MISSIONS MEDICAL COLLEGE |
DEPARTMENT OF
DERMATOLOGY, VENEREOLOGY AND LEPROSY, VINAYAKA MISSIONS MEDICAL COLLEGE, KARAIKAL
Karaikal
PONDICHERRY |
9884835199
hoddvdvmmckkl@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL 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 |
Microneedling with 5-fluorouracil 5 % cream in the treatment of vitiligo |
For patients with vitiligo 5-fluorouracil 5% cream with microneedling given at baseline then every 2 weeks for 3 months and followed up at monthly intervals for next 3 months |
| Comparator Agent |
Topical 88% phenol application in the treatment of vitiligo |
For patients with vitiligo Topical 88% phenol application given at baseline then every 2 weeks for 3 months and followed up at monthly intervals for next 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with clinical diagnosis of stable vitiligo Patients who are willing to participate in the study |
|
| ExclusionCriteria |
| Details |
Patients with unstable vitiligo
Patients allergic to 5-fluorouracil 5% cream and 88% phenol
Patients with predisposition to keloids
Patients and lactating mothers
Patients not willing for procedures |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Compare the clinical response by repigmentation to microneedling with 5-fluorouracil 5% cream and topical 88% phenol application in the treatment of vitiligo |
At the end of 3 months, and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Treatment side effects |
Every 4 weeks for 3 months |
|
|
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 2 |
|
Date of First Enrollment (India)
|
06/08/2023 |
| 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)
|
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
|
After applying inclusion and exclusion criteria .History and written consent from the patient is taken. Topical anesthesia will be applied over lesions .For Group A patients A layer of 5-FU cream 5% will be applied over the lesions. Microneedling will be done with DermaPen using the lowest speed with needle penetration depth. After cleaning with betadine, equal quantities of 5-FU cream 5% and fusidic acid cream 2% were applied The procedure will be repeated every 2 weeks for 6 sessions and followed up at monthly intervals for next 3 months For Group B Patients Topical 88% phenol will applied once gently with uniform smooth strokes to cover the entire lesion till an ivory white uniform frosting appeared. Prophylactic antibiotic cream will be applied twice in a day till the lesions healed Patients followed up at every 2 weeks for 3 months and at monthly intervals for next 3 month Clinical improvement and side effects will be assessed after each session .T The study will be concluded with the comparison of clinical improvement of both group A and group B study population. |