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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.

Comparative study of Microneedling with Topical 5- Fluorouracil 5 percent cream versus Topical Clobetasol propionate 0.05% in stable vitiligo - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/09/094957
Enrollment
40
Registered
2025-09-17
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: 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

Sponsors

Dhyani Vyas
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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.Timepoint: Baseline, 1 month, 2 months, 3 months

Secondary

MeasureTime frame
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 studyTimepoint: baseline, 1 month, 2 months, 3 months

Countries

India

Contacts

Public ContactDhyani Navneet Vyas

Sumandeep Vidyapeeth SBKS MIRC

drkishanninama.dermatologist@gmail.com9049764121

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026