| CTRI Number |
CTRI/2025/09/094957 [Registered on: 17/09/2025] Trial Registered Prospectively |
| Last Modified On: |
16/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A comparative study of efficacy between two different treatment modalities in stable vitiligo that is microneedling with topical 5-Fluorouracil cream versus potent topical corticosteroid- clobetasol cream. |
|
Scientific Title of Study
|
Comparative study of Microneedling with Topical 5- Fluorouracil 5 percent cream versus Topical Clobetasol propionate 0.05% 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 |
Dhyani Vyas |
| Designation |
First year MD Dermatology |
| Affiliation |
Sumandeep Vidyapeeth SBKS MIRC |
| Address |
Department of dermatology, OPD number 17, old building hospital, Sumandeep Vidyapeeth Waghodiya Road Waghodiya Pipariya Vadodara Gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
9049764121 |
| Fax |
|
| Email |
dhyanivyas47@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kishan Ninama |
| Designation |
Professor |
| Affiliation |
Sumandeep Vidyapeeth SBKS MIRC |
| Address |
Department of dermatology, opd number 17, old building Dhiraj hospital, Sumandeep Vidyapeeth Waghodiya Road Waghodiya Pipariya Vadodara Gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
9049764121 |
| Fax |
|
| Email |
drkishanninama.dermatologist@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dhyani Navneet Vyas |
| Designation |
First year MD Dermatology |
| Affiliation |
Sumandeep Vidyapeeth SBKS MIRC |
| Address |
Department of dermatology, opd number 17, old building Dhiraj hospital, Sumandeep Vidyapeeth Waghodiya Road Waghodiya Pipariya Vadodara Gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
9049764121 |
| Fax |
|
| Email |
dhyanivyas47@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sumandeep Vidyapeeth (SVDU) and Dhiraj hospital, Waghodiya road, Pipariya, Waghodiya, Vadodara, Gujarat, India Pin code: 391760 |
|
|
Primary Sponsor
|
| Name |
Dhyani Vyas |
| Address |
Sumandeep Vidyapeeth Waghodiya Road Waghodiya Pipariya Vadodara Gujarat |
| 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 |
| Dr Dhyani Vyas |
Sumandeep Vidyapeeth and Dhiraj Hospital |
Department of Dermatology, OPD no 17, Dhiraj Hospital old building, Sumandeep Vidyapeeth Waghodiya Road Waghodiya Pipariya Vadodara 391760
Vadodara
GUJARAT |
09049764121
dhyanivyas47@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sumandeep Vidyapeeth Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Stable Vitiligo |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Microneedling with 5- fluorouracil cream |
Microneedling on targeted area with 5% 5- Fluorouracil cream under occlusion for 24 hours once a month for 3 months after carrying out baseline investigations like (CBC, RBS, TSH). The total duration of study is 3 months and VASI score is compared for the targeted area, every month |
| Comparator Agent |
Topical corticosteroid |
Topical application of clobetasol propionate 0.05% on the targeted area |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All cases of stable vitiligo who have given consent for participation in the study and came to Skin OPD of Dhiraj Hospital or being referred from other departments
Patients who have not taken treatment or who have stopped all treatment for more than 1 month will be included in the study |
|
| ExclusionCriteria |
| Details |
Patients with unstable vitiligo
Patients with a history of photosensitive conditions, keloid, hypertrophic scar, Koebner’s phenomenon on the abraded areas will be excluded from the study
Pregnant as well as lactating women will be excluded.
Patients on treatment with topical or systemic steroids, immunosuppressive therapy, immunomodulators, phototherapy at the time of attending the OPD will be excluded.
Lesions over face, intertriginous areas, genitals, palms and soles will be excluded.
Patients who have undergone vitiligo surgery recently, for less than 1 year will be excluded.
Patients less than 12 years will be excluded.
Patients with other skin diseases like eczema, psoriasis or infection which can affect the treatment and the results will also be excluded.
Patients with minimal general health will be excluded.
Patients with bleeding disorder or coagulopathy will be excluded
Patients with hypersensitivity to 5- Fluorouracil or Clobetasol will be excluded
Patients with active skin or systemic infections will be excluded
Patients with associated disorders like diabetes mellitus, thyroid disorder, atopic dermatitis, pernicious anemia, internal malignancy and neurological disorders will also be excluded.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The response to therapies of vitiligo are variable but it is seen that combining medical management with better drug delivery enhancing systems like microneedling will increase the chances of repigmentation leading to better outcome and faster results. Hence, this will help in comparing and finding out a better treatment option for providing safe, effective and easily reproducible option for stable vitiligo, while taking into consideration the side effects observed within 3 months of study. |
Baseline, 1 month, 2 months, 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The response to therapies of vitiligo are variable but it is seen that combining medical management with better drug delivery enhancing systems like microneedling will increase the chances of repigmentation leading to better outcome & faster results. Hence, this will help in comparing & finding out a better treatment option for providing safe, effective & easily reproducible option for stable vitiligo, while taking into consideration the side effects observed at baseline, 1 month, 2 months & 3 months of study |
baseline, 1 month, 2 months, 3 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
01/10/2025 |
| 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 Applicable |
| 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
|
Vitiligo is an acquired primary disorder of pigmentation of unknown etiology, characterized clinically by depigmented macules and patches. Stability in vitiligo is defined as the absence of new lesions, no progression of existing lesions, and no occurrence of the Koebner phenomenon over the past year. Current treatment options include topical and systemic medications, phototherapy, laser therapy, and surgical interventions. Combined treatments, which integrate conventional and newer therapeutic methods, have shown superior efficacy, faster response, and better safety profiles compared to monotherapies. Microneedling is employed as a transdermal drug delivery technique to enhance the absorption of topical immunomodulators. The application of a microneedling device creates microchannels or pores in the stratum corneum, facilitating better drug penetration. This technique helps improve drug efficacy and may reduce the duration of treatment. 5-Fluorouracil (5-FU), an antimitotic agent known to stimulate melanocyte migration and proliferation, is being investigated for topical and intradermal use in the treatment of vitiligo. Topical corticosteroids are considered the first-line treatment for vitiligo. They are typically applied once or twice daily over the entire affected lesion and are especially useful in early or localized disease. The primary outcome of the study includes the clinical repigmentation, evaluated using G-score to compare the efficacy of such combined medical and surgical modalities with the standard treatment of vitiligo, that is, topical potent corticosteroid. Hence, this will help in comparing and finding out a better treatment option for providing safe, effective and easily reproducible option for stable vitiligo, while taking into consideration the side effects, if any, observed in the study. |