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Study comparing two different strengths of tacrolimus with excimer lamp in vitiligo

Double blind randomised control trial to study the repigmentation in non-segmental vitiligo using 0.1% tacrolimus/0.2% tacrolimus/placebo,in combination with excimer lamp

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/08/027127
Enrollment
27
Registered
2020-08-13
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: L80- Vitiligo Health Condition 2: L80- Vitiligo

Interventions

Intervention1: 0.2% tacrolimus with excimer lamp is the intervention: placebo with excimer lamp is the control Control Intervention1: 0.1% tacrolimus with excimer lamp is comparator: 27 patients is th

Sponsors

All India Institute of Medical Sciences New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients consenting to participate;able to visit hospital twice weekly for excimer and have ability to comprehend the different topical application on different patches with multiple or atleast three similar lesions of non-segmental vitiligo of more than 4 cm square size over non-glabrous skin,not developing new lesions or expansion of new lesions within past 2 months,not receiving any kind of systemic therapy for past one month and topical therapy for the past one week.

Exclusion criteria

Exclusion criteria: pregnant ,lactating mothers children less than 12 years active infection or bleeding at site Koebnerization for less than 1 month duration Lesions distal to wrist Patients with photosensitivity

Design outcomes

Primary

MeasureTime frame
Comparison of percentage mean re-pigmentation of the representative vitiligo patches in the each arms by using graphical method, photographic assessment and visual analogue scaleTimepoint: Three months

Secondary

MeasureTime frame
Measurement of blood levels of tacrolimus for systemic toxicity. Recording local and systemic adverse effects and comparing between three arms. Patient outcome over the course of the study by vis-22.Timepoint: Three months except blood tacrolimus levels at the end of one month of enrolling

Countries

India

Contacts

Public ContactDr Gouri RP Anand

All India Institute of Medical Sciences, New Delhi

Someshgupta@hotmail.com8448916412

Outcome results

None listed

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