Possible Augmentation Of NB-UVB Induced Pigmentation In N... | NCT07563049

Studies
Possible Augmentation Of NB-UVB Induced Pigmentation In NSV By Carboxy.

NCT07563049

Sponsor

Kasr El Aini Hospital

Status

Active, not recruiting

Last Update Posted

May 1, 2026Actual

Enrollment

59Actual

Phase

Phase 4

Conditions

Vitiligo Vulgaris

Interventions

NB-UVB alone
NB-UVB combined with carboxy

Countries

Egypt

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

Apr 2026

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

Sep 15, 2024Actual

Primary Completion Date

Dec 22, 2025Actual

Completion Date

Jun 1, 2026Estimated

First Submitted Date

Apr 25, 2026

First Submission Date that Met QC Criteria

Apr 25, 2026

First Posted Date

May 1, 2026Actual

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

Apr 25, 2026

Last Update Posted Date

May 1, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

Patients with stable vitiligo with 2 or more symmetric patches, 2 on acral sites and/or 2 on non acral sites will be recruited and assessed for eligibility for inclusion to receive NB-UVB on the whole body, and carboxytherapy on one randomized side.

Detailed Description

Not provided

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

59Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NB-UVB	Placebo Comparator		Device: NB-UVB alone
NB-UVB combined with carboxy	Active Comparator		Device: NB-UVB combined with carboxy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NB-UVB alone	Device	Narrow-Band Ultraviolet B phototherapy full cabin	NB-UVB

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Vitiligo Extent Score for a Target Area (VESTA)	Assessment of the treatment response in a target area Range 0-100%	6 months- 1 year
Estimation of human E-Cadherin using ELISA		6 months -1 year
Estimation of malondialdehyde by spectrophotometer		6 months-1 year

Secondary Outcomes

Measure	Description	Time Frame
Patients' global satisfaction	five-point grading scale -1-3	6 months -1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects with stable non-segmental vitiligo (≥2 symmetrical patches of diameter less than 2 cm on acral or ≥ 2 symmetrical patches on non-acral sites). Subjects were stable for twelve or more months.

Exclusion Criteria:

Subjects with unstable vitiligo.
- Subjects with segmental vitiligo.
- Pregnant females.
- Severe anemia (Hb <7 gm/dl).
- Cardiac/hepatic/renal/respiratory failure.
- Superficial thrombophlebitis.
- Subjects with history of skin malignancy or precancerous conditions like Xeroderma pigmentosum.
- Subjects with other autoimmune disorders.
- Systemic drugs for vitiligo in the last 3 months.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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
Faculty of Medicine, Cairo University		Cairo	El Manial	11956	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Study Protocol

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