NCT06880042

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started May 2025

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 17, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2025

Completed
Last Updated

June 24, 2025

Status Verified

March 1, 2025

Enrollment Period

2 months

First QC Date

March 11, 2025

Last Update Submit

June 23, 2025

Conditions

Vitiligo - Macular DepigmentationTacrolimus

Keywords

Vitiligo

Outcome Measures

Primary Outcomes (1)

  • VASI improvement upto 50%

    Improvement in VASI score upto 50%

    3 months

Study Arms (2)

Tacrolimus

ACTIVE COMPARATOR

Patient of Limited vitiligo less than 20% BSA will be treated with topical tacrolimus and narrowband UVB

Drug: Tacrolimus

Calcipotriol

ACTIVE COMPARATOR

Calcipotriol is a vitamin D analogue that will act as immunomodulator

Drug: Calcipotriol

Interventions

TacrolimusDRUG

Tacrolimus is calcineurin inhibitor that will act as immunomodulator

Tacrolimus
CalcipotriolDRUG

Calcipotriol is a vitamin D analogue that will act as immunomodulator

Calcipotriol

Eligibility Criteria

Age15 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lahore general.hospital

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Vitiligo

Interventions

Tacrolimuscalcipotriene

Condition Hierarchy (Ancestors)

HypopigmentationPigmentation DisordersSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Awahid

Study Record Dates

First Submitted

March 11, 2025

First Posted

March 17, 2025

Study Start

May 1, 2025

Primary Completion

June 30, 2025

Study Completion

August 30, 2025

Last Updated

June 24, 2025

Record last verified: 2025-03

Locations

PA(1)