COMPARISON OF EFFICACY AND SAFETY OF NARROWBAND UVB WITH 0.1% TACROLIMUS VS NARROWBAND UVB WITH 0.005% CALCIPOTRIOL IN TREATMENT OF VITILIGO (NB-UVB)

June 23, 2025 updated by: Dr ayesha wahid
Patient of stable and limited vitiligo less than 20% BSA will be recruited And evaluation of efficacy and safety of narrowband UVB with topical tacrolimus vs narrowband UVB and calcipotriol will be assessed

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Evaulation of efficacy and safety of narrowband uvb and tacrolimus and NBUVB and calcipotriol in patient if stable vitiligo with body surface area less than 20% It will be assessed by VASI score and VIisual analogie scale

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan
        • Lahore general.hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

- Localized vitiligo Age 15 to 70years Body surface upto 20% Stable more than 3 months

Exclusion Criteria:

  • • Pregnant or lactating female patients.

    • Skin malignancy or any other malignant skin condition.
    • Photo induced or photo aggravated dermatosis like (SLE, photodermatitis, rosacea, psoriasis, pemphigus vulgaris) along with vitiligo.
    • Prior history of allergy to tacrolimus or calcipotriol.
    • Other form of treatment for vitiligo within at least 1 month.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Tacrolimus
Patient of Limited vitiligo less than 20% BSA will be treated with topical tacrolimus and narrowband UVB
Drug: Tacrolimus
Tacrolimus is calcineurin inhibitor that will act as immunomodulator
Active Comparator: Calcipotriol
Calcipotriol is a vitamin D analogue that will act as immunomodulator
Drug: Calcipotriol
Calcipotriol is a vitamin D analogue that will act as immunomodulator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VASI improvement upto 50%
Time Frame: 3 months
Improvement in VASI score upto 50%
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr ayesha wahid

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2025

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

August 30, 2025

Study Registration Dates

First Submitted

March 11, 2025

First Submitted That Met QC Criteria

March 11, 2025

First Posted (Actual)

March 17, 2025

Study Record Updates

Last Update Posted (Actual)

June 24, 2025

Last Update Submitted That Met QC Criteria

June 23, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LGH

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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