To evaluate the efficacy and safety of 5-fluorouracil 5% cream versus tacrolimus 0.1% ointment versus stand alone with microneedling device in clinically stable vitiligo patients

An open label, non randomized, interventional study to evaluate the efficacy and safety of microneedling combined with 5-fluorouracil 5% cream versus microneedling combined with tacrolimus 0.1% ointment versus microneedling alone in clinically stable vitiligo patients - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/11/059621

Enrollment

Registered

2023-11-07

Start date

Unknown

Completion date

Unknown

Last updated

2023-11-13

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: Under strict aseptic conditions, microneedling of the vitiligo patches will be made using Dr.pen ultima A6. The needle penetration depth will be 0.25 to 0.5mm over face a

Eligibility

Inclusion criteria

Inclusion criteria: 1.All patients aged from 18 to 50 years with localized & stable vitiligo for a year willing to come for regular follow up. 2.No history of topical application for 2 weeks, oral medication for 4 weeks, phototherapy and excimer laser for 8 weeks when enrolled in the study. 3.Patients with 3 or more stable vitiligo patches

Exclusion criteria

Exclusion criteria: 1.Pregnant or lactating women 2.Presence of Bleeding /coagulation disorders 3.Past history of keloidal tendency 4.Patients with active infections 5.Patients with known allergy to 5-fluorouracil, tacrolimus 6.Immunosuppressed patients 7.Any concomitant skin conditions over the vitiligo patch 8.Mucosal and palmoplantar vitiligo

Design outcomes

Primary

Measure	Time frame
To evaluate the efficacy of microneedling combined with 5-fluorouracil 5% cream versus the efficacy of microneedling combined with tacrolimus 0.1% ointment versus microneedling alone in clinically stable vitiligo patientTimepoint: one year	—

Secondary

Measure	Time frame
To evaluate the safety of microneedling combined with 5-fluorouracil 5% cream versus the safety of microneedling combined with tacrolimus 0.1% ointment versus microneedling alone in clinically stable vitiligo patientsTimepoint: one year	—

Countries

India

Contacts

Public ContactDr Sushnitha Johnson

JAWAHARLAL NEHRU MEDICAL COLLEGE

bhavs1982@gmail.com9422306523

Outcome results