Back to resultsAuto-inoculation of a Wart in Multiple Viral Warts
Primary Purpose
Viral Wart, Delayed Hypersensitivity
Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Auto-inoculation
Sponsored by
About this trial
This is an interventional treatment trial for Viral Wart focused on measuring Autoinoculation, Viral Warts, Hypersensitivity, Immunology
Eligibility Criteria
Inclusion Criteria:
- Individuals having 5 or warts
- Individuals having any types of warts
Exclusion Criteria:
- Individuals using any other treatment for warts
Sites / Locations
- Pak Emirates Military HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Auto-inoculation recipients
Arm Description
Auto-inoculation of wart to be performed
Outcomes
Primary Outcome Measures
Complete Clearance of Warts
All the warts on any part of the body are cleared
Incomlete Clearance of Warts
No or size of warts are reduced
Non Responders
If no change or increased no of warts
Secondary Outcome Measures
Full Information
NCT ID
NCT04947332
First Posted
June 19, 2021
Last Updated
January 12, 2022
Sponsor
Pak Emirates Military Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04947332
Brief Title
Auto-inoculation of a Wart in Multiple Viral Warts
Official Title
Effectiveness of Auto-inoculation of a Wart in Multiple Viral Warts, in Tertiary Care Hospital : A Single Arm Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 8, 2021 (Actual)
Primary Completion Date
January 31, 2022 (Anticipated)
Study Completion Date
February 10, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pak Emirates Military Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Viral Wart, Delayed Hypersensitivity
Keywords
Autoinoculation, Viral Warts, Hypersensitivity, Immunology
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A single arm study
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Auto-inoculation recipients
Arm Type
Other
Arm Description
Auto-inoculation of wart to be performed
Intervention Type
Procedure
Intervention Name(s)
Auto-inoculation
Intervention Description
A wart will be excised from the body, minced and will be inoculated in a subcutaneous pocket on forearm.
Primary Outcome Measure Information:
Title
Complete Clearance of Warts
Description
All the warts on any part of the body are cleared
Time Frame
12 weeks
Title
Incomlete Clearance of Warts
Description
No or size of warts are reduced
Time Frame
12 weeks
Title
Non Responders
Description
If no change or increased no of warts
Time Frame
12 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Individuals having 5 or warts
Individuals having any types of warts
Exclusion Criteria:
Individuals using any other treatment for warts
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Waseem Shahid, MBBS
Phone
+923347202392
Email
waseem902@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nadia Iftikhar, MBBS, FCPS
Organizational Affiliation
Head of Department
Official's Role
Study Director
Facility Information:
Facility Name
Pak Emirates Military Hospital
City
Rawalpindi
State/Province
Punjab
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Muhammad W Shahid, MBBS
Phone
+923347202392
Email
waseem902@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Auto-inoculation of a Wart in Multiple Viral Warts
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