Efficacy of Oral Tofacitinib in Combination of Narrow Ban... | NCT07044141

Studies
Efficacy of Oral Tofacitinib in Combination of Narrow Band UVB in Treatment of Vitiligo

NCT07044141

Sponsor

Lahore General Hospital

Status

Active, not recruiting

Last Update Posted

Jun 29, 2025Actual

Enrollment

20Estimated

Phase

Phase 1

Conditions

Vitiligo

Interventions

Azathioprine
Tofacitinib

Countries

Pakistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2025Actual

Primary Completion Date

Sep 30, 2025Estimated

Completion Date

Sep 30, 2025Estimated

First Submitted Date

Jun 23, 2025

First Submission Date that Met QC Criteria

Jun 23, 2025

First Posted Date

Jun 29, 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 29, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

20 patients will be enrolled. All were given narrowband UVB . 10 wil be give oral azathriopfine . 10 will be given tofacitinib

Detailed Description

Total 20 patients will be enrolled. All were given narrowband UVB . 10 wil be give oral azathriopfine 50mg twice daily. 10 will be given tofacitinib 5mg twice daily. For 6 months

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

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A	Active Comparator	Azathioprine is an immunomodulator used in treatment of vitiligo	Drug: Azathioprine
Group B	Active Comparator	Tofacitinib It is a Janu kinase pathway inhibitor	Drug: Tofacitinib

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Azathioprine	Drug	azathioprine 50mg twice daily will be given	Group A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
VASI improvement upto 50%	Study will be considered efficacious if 50% improvement in VASI from baseline is seen by end of 6 months of study	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patient of vitiligo with any VASI both genders 18 to 60yrs

Exclusion Criteria:

pregnancy/lactation Hyerlipidrmia Patient on immunemodulator Histry pf tuberculosis Immunocompromised patients

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

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

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014820	Vitiligo

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001379	Azathioprine
C479163	tofacitinib

Ancestor Terms

ID	Term
D013872	Thionucleosides
D013457	Sulfur Compounds
D009930	Organic Chemicals
D015122	Mercaptopurine

Browse Leaves

Not provided

Browse Branches

Not provided