Gene Polymorphism in Tinea Versicolor | NCT04769804

Studies
Gene Polymorphism in Tinea Versicolor

NCT04769804

Sponsor

Kasr El Aini Hospital

Status

Unknown status

Last Update Posted

Apr 26, 2021Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Recurrent Pityriasis Versicolor

Interventions

Not provided

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

Feb 2021

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

Nov 1, 2019Actual

Primary Completion Date

Jun 1, 2021Estimated

Completion Date

Nov 1, 2021Estimated

First Submitted Date

Feb 21, 2021

First Submission Date that Met QC Criteria

Feb 21, 2021

First Posted Date

Feb 25, 2021Actual

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

Apr 22, 2021

Last Update Posted Date

Apr 26, 2021Actual

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

Blood samples will be taken from cases presenting with recurrent tinea versicolor , after confirmation of diagnosis by wood's light and KOH examination, for the detection of gene polymorphism in IL17 A and IL17 F.

In addition , serum samples from patients and controls will be tested for 25(OH)2 D3

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

200Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
IL 17A gene polymorphism	IL 17A	6months-1 year
IL 17 F gene polymorphism	IL 17 F	6months-1 year

Secondary Outcomes

Measure	Description	Time Frame
Vitamin D	Serum 25(OH)2 D3	6months-1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- Patients with recurrent pityriasis versicolor (active now) and not taking treatment for it.
Patients of both genders.
Age ≥18 years old.

Exclusion Criteria:

- Patients with other cutaneous diseases.
Patient's having dandruff (scaly scalp) even if not symptomatizing.
Pregnant and lactating females, children, prisoners, cognitively impaired or mentally disabled subjects.
Patients with autoimmune diseases.
Patients with immunodeficiency diseases.
Immunosuppressed patients e.g. HIV, diabetics, organ transplant, malignancy, patients taking immunosuppressive drugs e.g. chemotherapy, cortisone.

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 history of disseminated TV, with 2 or more episodes of TV per year.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Rana Hilal, MD	Contact	01001488869	+20	rana.hilal@kasralainy.edu.eg

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kasr Al Ainy Hospital, Cairo university	Recruiting	Cairo	El Manial	11956	Egypt

Condition Browse Module

MeSH Terms

ID	Term
D014010	Tinea Versicolor

Ancestor Terms

ID	Term
D003881	Dermatomycoses
D009181	Mycoses
D001423	Bacterial Infections and Mycoses
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Label	Type	Description	Intervention Names
Patients with recurrent pityriasis versicolor
Healthy age and sex-matched controls