Expression of LC3-I, LC3-II & Beclin 1 in Vitiligo | NCT03371758

Studies
Expression of LC3-I, LC3-II & Beclin 1 in Vitiligo

NCT03371758

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Jan 23, 2018Actual

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Autophagy

Interventions

skin biopsy

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

Jan 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2017Actual

Primary Completion Date

May 2018Estimated

Completion Date

May 2018Estimated

First Submitted Date

Dec 5, 2017

First Submission Date that Met QC Criteria

Dec 8, 2017

First Posted Date

Dec 13, 2017Actual

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

Jan 19, 2018

Last Update Posted Date

Jan 23, 2018Actual

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

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
vitiligo patients	Experimental		Other: skin biopsy
healthy controls	Experimental		Other: skin biopsy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
skin biopsy	Other	Punch skin biopsy will be taken from the lesional and non-lesional skin of vitiligo patients as well as healthy skin of controls.	healthy controls

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Expression of LC3-I, LC3-II & Beclin 1 in vitiligo patients		1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

• Patients with non-segmental vitiligo whether active or stable.
- Age above 12 years.
- Both sexes.

Exclusion Criteria:

• Patients should not use any topical or systemic treatment at least 6 weeks before inclusion into the study.
- Patients having other autoimmune disease, heart disease, liver disease, kidney disease, neurological disorder, cancer, active infection or any chronic disease.
- Pregnancy or breast feeding for female patients.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder 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
Maha Fathy Elmasry	Recruiting	Cairo			Egypt