Triple Intralesional Immunotherapy Combination in Multiple Recalcitrant WartsPhase 2/3NCT05254561
Triple Antigen vs Monoantigen Immunotherapy for Warts
A Phase 2/3 study testing Intralesional antigen immunotherapy in people with Triple Intralesional Immunotherapy Combination in Multiple Recalcitrant Warts, run by Zagazig University at 1 site in Egypt.
Trial summary
Warts can be resistant to treatment or return despite the use of many therapeutic modalities. Combining immunotherapy might contribute to better response rates, particularly in recalcitrant warts, which is a real therapeutic challenge. Read more about this study
- Who is it for?
- Ages 10 to 70 years
- Conditions the study is for
- Triple Intralesional Immunotherapy Combination in Multiple Recalcitrant Warts
- What is being tested?
- Intralesional antigen immunotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Nov 2020to 15 Nov 2021
- Phase
- Phase 2/3
- 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 10 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Multiple (> 3 warts) recalcitrant (at least 6 months duration and who did not respond to at least 2 treatment modalities) warts of different sites, size and duration
Who cannot join
- Patients with acute febrile illness or past history of asthma.
- Allergic skin disorders such as generalized eczema and urticaria.
- Past history of meningitis or convulsions.
- Pregnancy or lactation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Triple Intralesional Antigen Immunotherapy Versus Monoantigen in the Treatment of Multiple Recalcitrant Warts
Warts can be resistant to treatment or return despite the use of many therapeutic modalities. Combining immunotherapy might contribute to better response rates, particularly in recalcitrant warts, which is a real therapeutic challenge. The purpose of this study was to assess the effectiveness and safety of a triple intralesional immunotherapy combination composed of PPD, Candida antigen and MMR versus either agent alone in the management of multiple recalcitrant warts.
Read the detailed description
This study included 160 patients with multiple (>3 warts) recalcitrant (at least 6 months duration and who did not respond to at least 2 treatment modalities) warts of different sites, size and duration, with or without distant warts after approval of the Institutional Review Board of Faculty of medicine, Zagazig university. They were randomly assigned to one of four groups (each with 40 patients): PPD, Candida antigen, MMR, or combination of the 3 antigens. Injections into the biggest wart were repeated every two weeks until clearance or for a total of five sessions.
- Being tested
- Intralesional antigen immunotherapy
- Keywords
- triple intralesional immunotherapy, Warts, tuberculin purified protein derivative, Candida antigen, Measles-Mumps-Rubella vaccine, combination immunotherapy
- Medical subject headings
- Warts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intralesional antigen immunotherapyBiological
Also called PPD, Candida antigen, and MMR
Randomized double-blinded comparative effectiveness and safety clinical trial
| Study group | Role | What they receive |
|---|---|---|
| purified protein derivative (PPD) | Active comparator | Group A Receives: Biological: Intralesional antigen immunotherapy |
| Candida antigen. | Active comparator | Group B Receives: Biological: Intralesional antigen immunotherapy |
| Measles, Mumps and Rubella vaccine (MMR). | Active comparator | Group C Receives: Biological: Intralesional antigen immunotherapy |
| Triple combination of PPD, Candida antigen and MMR | Active comparator | Group D Receives: Biological: Intralesional antigen immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall complete response of both treated and distant warts
Measured: within 12 weeks of starting treatment sessions (up to 1 month after the last session, maximum 5 sessions)
Immediate adverse effects
Measured: during and till 20 minutes after intralesional injection immunotherapy
Secondary outcomes (4)
Distant wart clearance
Measured: within 12 weeks of starting sessions
Time to complete clearance
Measured: within 12 weeks of starting therapy
late adverse effects
Measured: after each session and till the end of sessions and 6 months-follow-up period
Recurrence
Measured: For 6 months after complete response
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study start20 Nov 2020
- Primary completion20 Jun 2021
- Study completion15 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple Intralesional Immunotherapy Combination in Multiple Recalcitrant WartsStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assignment
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Basma Magdy Elkholy, MD, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05254561
- Sponsor's protocol ID
- IRB# 6526/-15-11-2020
- Status last verified
- Feb 2022
- First submitted
- 14 Feb 2022
- Last updated
- 24 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Triple Intralesional Antigen Immunotherapy Versus Monoantigen in the Treatment of Multiple Recalcitrant Warts
- ClinicalTrials.gov ID
- NCT05254561
- Acronym / sponsor ID
- IRB# 6526/-15-11-2020
- Keywords
- triple intralesional immunotherapy, Warts, tuberculin purified protein derivative, Candida antigen, Measles-Mumps-Rubella vaccine, combination immunotherapy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 20 Nov 2020 (actual)
- Primary completion
- 20 Jun 2021 (actual)
- Study completion
- 15 Nov 2021 (actual)
- First posted
- 24 Feb 2022 (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.
Warts can be resistant to treatment or return despite the use of many therapeutic modalities. Combining immunotherapy might contribute to better response rates, particularly in recalcitrant warts, which is a real therapeutic challenge. The purpose of this study was to assess the effectiveness and safety of a triple intralesional immunotherapy combination composed of PPD, Candida antigen and MMR versus either agent alone in the management of multiple recalcitrant warts.
Detailed description
This study included 160 patients with multiple (>3 warts) recalcitrant (at least 6 months duration and who did not respond to at least 2 treatment modalities) warts of different sites, size and duration, with or without distant warts after approval of the Institutional Review Board of Faculty of medicine, Zagazig university. They were randomly assigned to one of four groups (each with 40 patients): PPD, Candida antigen, MMR, or combination of the 3 antigens. Injections into the biggest wart were repeated every two weeks until clearance or for a total of five sessions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Parallel assignment
| Arm | Type | Receives |
|---|---|---|
| purified protein derivative (PPD) | Active comparator | Biological: Intralesional antigen immunotherapyGroup A |
| Candida antigen. | Active comparator | Biological: Intralesional antigen immunotherapyGroup B |
| Measles, Mumps and Rubella vaccine (MMR). | Active comparator | Biological: Intralesional antigen immunotherapyGroup C |
| Triple combination of PPD, Candida antigen and MMR | Active comparator | Biological: Intralesional antigen immunotherapyGroup D |
Who may qualify
- Ages
- 10 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Multiple (> 3 warts) recalcitrant (at least 6 months duration and who did not respond to at least 2 treatment modalities) warts of different sites, size and duration
Key exclusion criteria (4 listed)
- Patients with acute febrile illness or past history of asthma.
- Allergic skin disorders such as generalized eczema and urticaria.
- Past history of meningitis or convulsions.
- Pregnancy or lactation.
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 |
|---|---|---|
| Intralesional antigen immunotherapyAlso: PPD, Candida antigen, and MMRRandomized double-blinded comparative effectiveness and safety clinical trial | Biological | Candida antigen., Measles, Mumps and Rubella vaccine (MMR)., Triple combination of PPD, Candida antigen and MMR, purified protein derivative (PPD) |
Primary outcome
Overall complete response of both treated and distant warts
Time frame: within 12 weeks of starting treatment sessions (up to 1 month after the last session, maximum 5 sessions)
Immediate adverse effects
Time frame: during and till 20 minutes after intralesional injection immunotherapy
4 secondary outcomes
Distant wart clearance
Time frame: within 12 weeks of starting sessions
Time to complete clearance
Time frame: within 12 weeks of starting therapy
late adverse effects
Time frame: after each session and till the end of sessions and 6 months-follow-up period
Recurrence
Time frame: For 6 months after complete response
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2022.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Intralesional antigen immunotherapy in people with Triple Intralesional Immunotherapy Combination in Multiple Recalcitrant Warts, run by Zagazig University at 1 site in Egypt.
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 24 Feb 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 Egypt. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall complete response of both treated and distant warts (time frame: within 12 weeks of starting treatment sessions (up to 1 month after the last session, maximum 5 sessions)). The study lists 2 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 24 Feb 2022.