Interleukin 4 and Interferon Gamma Predictors of Human Pa... | NCT05100043

Studies
Interleukin 4 and Interferon Gamma Predictors of Human Papillomavirus Immunotherapy in Warts

NCT05100043

Sponsor

Zagazig University

Status

Completed

Last Update Posted

Feb 19, 2025Actual

Enrollment

80Actual

Phase

Not provided

Conditions

Warts Hand
Wart, Genital

Interventions

IL-4 and IFN-γ measurements

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 2025

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 3, 2020Actual

Primary Completion Date

Jul 3, 2020Actual

Completion Date

Mar 2, 2021Actual

First Submitted Date

Oct 5, 2021

First Submission Date that Met QC Criteria

Oct 18, 2021

First Posted Date

Oct 29, 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

Feb 17, 2025

Last Update Posted Date

Feb 19, 2025Actual

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

In the present study the investigators assessed the invitro role of IL-4 and IFN-γ in predicting the response to bivalent HPV vaccine after whole blood stimulation

Detailed Description

40 Patients and 40 controls are enrolled in the study. Participants suffer from chronic recurrent cutaneous and genital warts. Blood samples were withdrawn then whole blood cultures are prepared. Cultures are stimulated with bivalent HPVvaccine. IL-4 and IFN-γ measurement in culture supernatants by ELISA. IL-4 and IFN-γ are investigated to predict the therapeutic response to bivalent HPV vaccine immunotherapy in warts.

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

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cases		Patients having multiple recurrent and recalcitrant cutaneous and genital warts	Biological: IL-4 and IFN-γ measurements
Controls		Healthy volunteers matched for age and sex	Biological: IL-4 and IFN-γ measurements

Interventions

Name	Type	Description	Arm Group Labels	Other Names
IL-4 and IFN-γ measurements	Biological	Blood samples are withdrawn from participants and whole blood cultures are prepared and stimulated by bivalent HPV vaccine.IL-4 and IFN-γ are measured in culture supernatants

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change of IFN-γ and IL-4 levels	Quantitative measurement of IFN-γ and IL-4 in culture supernatants	48 hours

Secondary Outcomes

Measure	Description	Time Frame
Change in the size of warts	Clinical observation and photographing of wart size	6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with recurrent and recalcitrant cutaneous and anogenital warts.

Exclusion Criteria:

History of allergy to the HPV vaccine
Active viral, fungal, or bacterial infections
Immunosuppressive diseases or drugs.
Autoimmune diseases, or other systemic diseases, e.g., hepatic, or renal disorders, diabetes, meningitis or convulsions
Skin allergies
Pregnancy and lactation
Earlier wart treatment at least one month before enrollment.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

36 Months

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients are attendants in Zagazig University Hospitals Dermatology outpatient clinic

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ayman Marei, MD, PhD	Faculty of Medicine, Zagazig University , Zagazig, Egypt	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zagazig University Faculty of Medicine		Zagazig	Sharqia Province	44519	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003218	Condylomata Acuminata

Ancestor Terms

ID	Term
D030361	Papillomavirus Infections
D015229	Sexually Transmitted Diseases, Viral
D012749	Sexually Transmitted Diseases
D003141	Communicable Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015847	Interleukin-4

Ancestor Terms

ID	Term
D007378	Interleukins
D016207	Cytokines
D036341	Intercellular Signaling Peptides and Proteins
D010455	Peptides

Browse Leaves

Not provided

Browse Branches

Not provided