NCT06546059

Brief Summary

The aim of this study is to:

  1. 1.Evaluate the role of tissue Gasdermin D expression using immunehistochemstry techniques in patients with generalized vitiligo and compare it with healthy controls.
  2. 2.Evaluation expression of tissue Gasdermin D using immunehistochemstry techniques in patients with generalized vitiligo after narrow band ultraviolet B therapy.
  3. 3.Determine whether there is a relationship between Gasdermin D levels and disease duration and involved body surface area (VISA) in vitiligo patients.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2024

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

August 5, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 9, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
Last Updated

August 9, 2024

Status Verified

August 1, 2024

Enrollment Period

2 months

First QC Date

August 5, 2024

Last Update Submit

August 8, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Evaluate the role of tissue Gasdermin D expression using immunehistochemstry techniques in patients with generalized vitiligo and compare it with healthy controls.

    1- Evaluate the role of tissue Gasdermin D expression using immunehistochemstry techniques in patients with generalized vitiligo and compare it with healthy controls.techniques in patients with generalized vitiligo and compare it with healthy controls.

    three months

Secondary Outcomes (2)

  • 2- Evaluation expression of tissue Gasdermin D using immunehistochemstry techniques in patients with generalized vitiligo after narrow band ultraviolet B therapy.

    three months

  • 3- Determine whether there is a correlation between tissue immunehistochemstry Gasdermin D levels and disease duration and involved body surface area (VISA) in vitiligo patients.

    three months

Study Arms (1)

one group

OTHER
Device: narrow band ultraviolet-B

Interventions

vitiligo patients will recevie twice sessions per week

one group

Eligibility Criteria

Age10 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with stable vitiligo of 6 months duration,
  • Both sex and ages(10-75)

You may not qualify if:

  • pregnancy,
  • lactation,
  • patients under or previous phototherapy,
  • patients on other immunosuppressives,
  • patients receiving topical or systemic therapy like antioxidants and vitamins were kept off treatment for 2 weeks prior to recruitment into the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Vitiligo

Condition Hierarchy (Ancestors)

HypopigmentationPigmentation DisordersSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Soheir Abdel-Hamid, MD

CONTACT

Basma Tito Abd Elhameed, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Soheir Abdel-Hamid, principle investigator

Study Record Dates

First Submitted

August 5, 2024

First Posted

August 9, 2024

Study Start

August 1, 2024

Primary Completion

October 1, 2024

Study Completion

November 1, 2024

Last Updated

August 9, 2024

Record last verified: 2024-08