NCT06209138

Brief Summary

Vitiligo, a significant dermatologic challenge affecting 0.5 to 2% of the global population. Despite various existing medical approaches, current vitiligo treatments are still far from optimal.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

December 22, 2023

Completed
26 days until next milestone

First Posted

Study publicly available on registry

January 17, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

January 23, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2024

Completed
Last Updated

April 17, 2024

Status Verified

April 1, 2024

Enrollment Period

3 months

First QC Date

December 22, 2023

Last Update Submit

April 15, 2024

Conditions

Vitiligo

Keywords

5FUFilm forming gelvitiligoJAK3 gene expressionDermabrasion

Outcome Measures

Primary Outcomes (2)

  • Guartile grading scale

    A grading system with a quartile grading scale was used. Here, grading of \> 75% will be considered excellent improvement, very good (51-75%), good (50-25%), poor (\<25%), mild (25%), and poor improvement if less than 25% grading.

    2 months

  • analysis of Jak3 expression in vitiligo lesions

    the improvement will be associated with a reduction in JAK levels

    2months

Study Arms (2)

CO2 laser assisted dermabrasion and 5FU film

EXPERIMENTAL
Drug: 5 fluorouracil

CO2 laser assisted dermabrasion and saline

ACTIVE COMPARATOR
Other: Saline

Interventions

5 fluorouracilDRUG

5 fluorouracil (5FU) using different ratios of hydroxyl propyl methyl cellulose (HPMC) and Zein

CO2 laser assisted dermabrasion and 5FU film
SalineOTHER

Normal saline solution contains 0.9 percent sodium chloride (salt)

CO2 laser assisted dermabrasion and saline

Eligibility Criteria

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

You may qualify if:

  • Patients with stable vitlligo

You may not qualify if:

  • patients under the age of 10 years.
  • Individuals with a history of the Koebner phenomenon, a tendency for keloid or hypertrophic scarring
  • Pregnancy.
  • Recent isotretinoin therapy within the last 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al-Azhar University

Asyut, No State, Egypt

Location

MeSH Terms

Conditions

Vitiligo

Interventions

FluorouracilSodium Chloride

Condition Hierarchy (Ancestors)

HypopigmentationPigmentation DisordersSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

UracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 22, 2023

First Posted

January 17, 2024

Study Start

January 23, 2024

Primary Completion

April 15, 2024

Study Completion

April 15, 2024

Last Updated

April 17, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)