Thymic Stromal Lymphopoietin (TSLP) in Vitiligo | NCT03367273

Studies
Thymic Stromal Lymphopoietin (TSLP) in Vitiligo

NCT03367273

Sponsor

Cairo University

Status

Completed

Last Update Posted

Dec 20, 2017Actual

Enrollment

50Actual

Phase

Not Applicable

Conditions

Vitiligo

Interventions

skin 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

Dec 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2017Actual

Primary Completion Date

Jul 2017Actual

Completion Date

Jul 2017Actual

First Submitted Date

Dec 5, 2017

First Submission Date that Met QC Criteria

Dec 5, 2017

First Posted Date

Dec 8, 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

Dec 18, 2017

Last Update Posted Date

Dec 20, 2017Actual

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

Description Module

Brief Summary

study & verify the hypothesis of the involvement of TSLP in the pathogenesis of vitiligo in comparison to their levels in the healthy control persons.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
skin biopsy	Other	Lesional skin biopsy was taken from every patient. Also a skin biopsy was taken from every control subject	controls vitiligo patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Expression levels of TSLP in patients of Vitiligo.		7 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

• Patients with generalized non-segmental vitiligo.
- Both sexes.
- Age < 18 years old age.
- New cases or cases not receiving any medication for at least 3 months ago.

Exclusion Criteria:

• Age: Patients < 18 years.
- Segmental or universal vitiligo.
- Pregnant and lactating females. Autoimmune diseases

Accepts Healthy Volunteers

Yes

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

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