Auto-inoculation of a Wart in Multiple Viral Warts | NCT04947332

Studies
Auto-inoculation of a Wart in Multiple Viral Warts

NCT04947332

Sponsor

Pak Emirates Military Hospital

Status

Unknown status

Last Update Posted

Jan 13, 2022Actual

Enrollment

80Estimated

Phase

Not Applicable

Conditions

Viral Wart
Delayed Hypersensitivity

Interventions

Auto-inoculation

Countries

Pakistan

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

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 2022

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

Feb 8, 2021Actual

Primary Completion Date

Jan 31, 2022Estimated

Completion Date

Feb 10, 2022Estimated

First Submitted Date

Jun 19, 2021

First Submission Date that Met QC Criteria

Jun 23, 2021

First Posted Date

Jul 1, 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

Jan 12, 2022

Last Update Posted Date

Jan 13, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Muhammad Waseem Shahid, Resident Dermatology, Pak Emirates Military HospitalPrincipal Investigator

Lead Sponsor

Pak Emirates Military HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

This study is being conducted to see effectiveness of auto-inoculation of a wart in multiple viral warts. Patients with recurrent, multiple warts of all types, are being recruited for the study. A wart is excised, minced and then inoculated in a subcutaneous pocket made on the volar aspect of forearm. Patients are to be reviewed after every 4 weeks to note any reduction in number warts.

Detailed Description

A single arm, Phase 1, Clinical Study

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

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Auto-inoculation recipients	Other	Auto-inoculation of wart to be performed	Procedure: Auto-inoculation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Auto-inoculation	Procedure	A wart will be excised from the body, minced and will be inoculated in a subcutaneous pocket on forearm.	Auto-inoculation recipients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Complete Clearance of Warts	All the warts on any part of the body are cleared	12 weeks
Incomlete Clearance of Warts	No or size of warts are reduced	12 weeks
Non Responders	If no change or increased no of warts	12 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Individuals having 5 or warts
Individuals having any types of warts

Exclusion Criteria:

Individuals using any other treatment for warts

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Waseem Shahid, MBBS	Contact	+923347202392		waseem902@yahoo.com

Overall Officials

Name	Affiliation	Role
Nadia Iftikhar, MBBS, FCPS	Head of Department	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pak Emirates Military Hospital	Recruiting	Rawalpindi	Punjab Province		Pakistan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Date	Date Unknown
Release	Mar 17, 2022
Reset	Jun 30, 2022

Submission Tracking

Estimated Results First Submitted Date

Mar 17, 2022

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Mar 17, 2022			Jun 30, 2022

Condition Browse Module

MeSH Terms

ID	Term
D014860	Warts
D006968	Hypersensitivity, Delayed
D006967	Hypersensitivity

Ancestor Terms

ID	Term
D030361	Papillomavirus Infections
D004266	DNA Virus Infections
D014777	Virus Diseases
D007239	Infections

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