COMPARISON OF EFFICACY AND SAFETY OF NARROWBAND UVB WITH... | NCT06880042

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2025Actual

Primary Completion Date

Jun 30, 2025Estimated

Completion Date

Aug 30, 2025Estimated

First Submitted Date

Mar 11, 2025

First Submission Date that Met QC Criteria

Mar 11, 2025

First Posted Date

Mar 17, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 23, 2025

Last Update Posted Date

Jun 24, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Tacrolimus	Drug	Tacrolimus is calcineurin inhibitor that will act as immunomodulator	Tacrolimus

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

70 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Lahore general.hospital		Lahore	Punjab Province		Pakistan

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

ID	Term
D017496	Hypopigmentation
D010859	Pigmentation Disorders
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

ID	Term
D016559	Tacrolimus
C055085	calcipotriene

ID	Term
D018942	Macrolides
D007783	Lactones
D009930	Organic Chemicals