Viral WartNCT04947332
Auto-inoculation of a Wart in Multiple Viral Warts
A study testing Auto-inoculation in people with Viral Wart and Delayed Hypersensitivity, run by Pak Emirates Military Hospital at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Viral Wart, Delayed Hypersensitivity
- What is being tested?
- Auto-inoculation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 sitePakistan
- Study dates
- 8 Feb 2021to 10 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Individuals having 5 or warts
- Individuals having any types of warts
Who cannot join
- Individuals using any other treatment for warts
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Pak Emirates Military Hospital
Rawalpindi, Punjab Province
Muhammad W Shahid, MBBS, +923347202392, waseem902@yahoo.com
About this study
Official title: Effectiveness of Auto-inoculation of a Wart in Multiple Viral Warts, in Tertiary Care Hospital : A Single Arm Study
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.
Read the detailed description
A single arm, Phase 1, Clinical Study
- Conditions
- Viral Wart, Delayed Hypersensitivity
- Being tested
- Auto-inoculation
- Keywords
- Autoinoculation, Viral Warts, Hypersensitivity, Immunology
- Medical subject headings
- Warts, Hypersensitivity, Delayed, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auto-inoculationProcedure or surgery
A wart will be excised from the body, minced and will be inoculated in a subcutaneous pocket on forearm.
| Study group | Role | What they receive |
|---|---|---|
| Auto-inoculation recipients | Other | Auto-inoculation of wart to be performed Receives: Procedure: Auto-inoculation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Clearance of Warts
All the warts on any part of the body are cleared
Measured: 12 weeks
Incomlete Clearance of Warts
No or size of warts are reduced
Measured: 12 weeks
Non Responders
If no change or increased no of warts
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2021
- Study start8 Feb 2021
- Primary completion31 Jan 2022 (estimated)
- Study completion10 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Viral WartStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A single arm study
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pak Emirates Military Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Waseem Shahid, Pak Emirates Military Hospital
- Investigators
- Nadia Iftikhar, MBBS, FCPS, Study director, Head of Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04947332
- Sponsor's protocol ID
- A/28/EC/230/2021
- Status last verified
- Jan 2022
- First submitted
- 19 Jun 2021
- Last updated
- 13 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Auto-inoculation of a Wart in Multiple Viral Warts, in Tertiary Care Hospital : A Single Arm Study
- ClinicalTrials.gov ID
- NCT04947332
- Acronym / sponsor ID
- A/28/EC/230/2021
- Conditions
- Viral Wart, Delayed Hypersensitivity
- Keywords
- Autoinoculation, Viral Warts, Hypersensitivity, Immunology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Pak Emirates Military HospitalUniversity, hospital or other
- Study start
- 8 Feb 2021 (actual)
- Primary completion
- 31 Jan 2022 (estimated)
- Study completion
- 10 Feb 2022 (estimated)
- First posted
- 1 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single arm study
| Arm | Type | Receives |
|---|---|---|
| Auto-inoculation recipients | Other | Procedure: Auto-inoculationAuto-inoculation of wart to be performed |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Individuals having 5 or warts
- Individuals having any types of warts
Key exclusion criteria (1 listed)
- Individuals using any other treatment for warts
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auto-inoculationA wart will be excised from the body, minced and will be inoculated in a subcutaneous pocket on forearm. | Procedure or surgery | Auto-inoculation recipients |
Primary outcome
Complete Clearance of Warts
Time frame: 12 weeks
All the warts on any part of the body are cleared
Incomlete Clearance of Warts
Time frame: 12 weeks
No or size of warts are reduced
Non Responders
Time frame: 12 weeks
If no change or increased no of warts
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nadia Iftikhar, MBBS, FCPS study director
Head of Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auto-inoculation in people with Viral Wart and Delayed Hypersensitivity, run by Pak Emirates Military Hospital at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Waseem Shahid, MBBS (+923347202392, waseem902@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Clearance of Warts (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2022.