IL35 Level in Vitiligo | NCT05980390

Studies
IL35 Level in Vitiligo

NCT05980390

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Aug 8, 2023Actual

Enrollment

84Estimated

Phase

Not provided

Conditions

IL35, Vitiligo

Interventions

IL 35 in tissue biopsy

Countries

Not provided

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

Jul 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 10, 2023Estimated

Primary Completion Date

Sep 30, 2023Estimated

Completion Date

Oct 30, 2023Estimated

First Submitted Date

Jul 29, 2023

First Submission Date that Met QC Criteria

Aug 7, 2023

First Posted Date

Aug 8, 2023Actual

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

Aug 7, 2023

Last Update Posted Date

Aug 8, 2023Actual

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

The aim of this observational study is to evaluate the level of the IL-35 protein in tissue biopsy from patients with active & stable vitiligo.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

84Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Active vitiligo			Diagnostic Test: IL 35 in tissue biopsy
Stable vitiligo			Diagnostic Test: IL 35 in tissue biopsy
Normal controls			Diagnostic Test: IL 35 in tissue biopsy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
IL 35 in tissue biopsy	Diagnostic Test	Elisa testing	Active vitiligo Normal controls Stable vitiligo

Measure	Description	Time Frame
level of IL35 in tissue biopsy		3 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with active and stable vitiligo

Exclusion Criteria:

Pregnant and lactating women.
Patients with associated autoimmune or other dermatological diseases e.g., Alopecia areata and lupus erythematous.
Patients already on both topical and systemic treatment at the time of recruitment.
Patients on Immunosuppressive drugs.
Other hypopigmented diseases such as pityriasis alba, tinea versicolor, lichen sclerosis, post inflammatory hypopigmentation and leprosy as excluded by lack of accentuation by wood's light examination.

Accepts Healthy Volunteers

Not provided

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

Patients with active and stable vitiligo together with normal subjects

Sampling Method

Probability Sample

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

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Browse Branches

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