WartsPhase 2NCT04399577
Complement Component 3c and Tumor Necrosis Factor-α in Patients With Human Papillomavirus-Induced Cutaneous Warts
A Phase 2 study testing Candida antigen in people with Warts, run by Zagazig University at 1 site in Egypt.
Trial summary
The investigators explore the role of the complement pathway and T helper 1 immune response in clinical response to Candida immunotherapy via complement component and tumor necrosis factor, respectively. Read more about this study
- Who is it for?
- Ages 9 to 45 years
- Conditions the study is for
- Warts
- What is being tested?
- Candida antigen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2017to 3 Sep 2019
- Phase
- Phase 2
- 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 9 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Chronic multiple cutaneous
Who cannot join
- Hypersensitivity to Candida antigen
- Fever
- Immunosuppressive disorders
- Previous wart therapy in the last month
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Zagazig University Faculty of Medicine
Zagazig, Sharqia Province, 44519
About this study
The investigators explore the role of the complement pathway and T helper 1 immune response in clinical response to Candida immunotherapy via complement component and tumor necrosis factor, respectively.
Read the detailed description
39 patients are enrolled in the study They suffer from chronic recurrent cutaneous warts Patients receive Candida antigen immunotherapy vial intra-lesional injection every 2 weeks till complete resolution or the maximum of 5 sessions Blood samples are withdrawn before and after intervention C3, C4, MBL, C3C and TNF alpha serum levels are measured
- Conditions
- Warts
- Being tested
- Candida antigen
- Medical subject headings
- Warts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Candida antigenBiological
Patient receive candida antigen immunotherapy and blood samples will be withdrawn before and after intervention
| Study group | Role | What they receive |
|---|---|---|
| Wart Patients | Experimental | Patient receive 0.1 mL of diluted preparation of candida solution at 2 weeks interval for the maximum of 5 sessions Receives: Biological: Candida antigen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resolution of warts
100% clearance of warts
Measured: 12 weeks
Secondary outcomes (1)
Recurrence
Reappearance of warts
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2020
- Study start1 Jul 2017
- Primary completion3 Mar 2019
- Study completion3 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Noha M Hammad, MD, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04399577
- Sponsor's protocol ID
- 3140/23-10-2016
- Status last verified
- May 2020
- First submitted
- 19 May 2020
- Last updated
- 27 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hammad NM, Abdelhadi AA, Fawzy MM, Marei A. Complement component 3c and tumor necrosis factor-alpha systemic assessment after Candida antigen immunotherapy in cutaneous warts. Braz J Microbiol. 2020 Dec;51(4):1673-1681. doi: 10.1007/s42770-020-00322-0. Epub 2020 Jun 27.
PubMed 32594377
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complement Component 3c and Tumor Necrosis Factor-α in Patients With Human Papillomavirus-Induced Cutaneous Warts
- ClinicalTrials.gov ID
- NCT04399577
- Acronym / sponsor ID
- 3140/23-10-2016
- Conditions
- Warts
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 3 Mar 2019 (actual)
- Study completion
- 3 Sep 2019 (actual)
- First posted
- 22 May 2020 (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.
The investigators explore the role of the complement pathway and T helper 1 immune response in clinical response to Candida immunotherapy via complement component and tumor necrosis factor, respectively.
Detailed description
39 patients are enrolled in the study They suffer from chronic recurrent cutaneous warts Patients receive Candida antigen immunotherapy vial intra-lesional injection every 2 weeks till complete resolution or the maximum of 5 sessions Blood samples are withdrawn before and after intervention C3, C4, MBL, C3C and TNF alpha serum levels are measured
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Wart Patients | Experimental | Biological: Candida antigenPatient receive 0.1 mL of diluted preparation of candida solution at 2 weeks interval for the maximum of 5 sessions |
Who may qualify
- Ages
- 9 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Chronic multiple cutaneous
Key exclusion criteria (4 listed)
- Hypersensitivity to Candida antigen
- Fever
- Immunosuppressive disorders
- Previous wart therapy in the last month
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 |
|---|---|---|
| Candida antigenPatient receive candida antigen immunotherapy and blood samples will be withdrawn before and after intervention | Biological | Wart Patients |
Primary outcome
Resolution of warts
Time frame: 12 weeks
100% clearance of warts
1 secondary outcome
Recurrence
Time frame: 6 months
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 27 May 2020.
- Derived from this study: PubMed 32594377Hammad NM, Abdelhadi AA, Fawzy MM, Marei A. Complement component 3c and tumor necrosis factor-alpha systemic assessment after Candida antigen immunotherapy in cutaneous warts. Braz J Microbiol. 2020 Dec;51(4):1673-1681. doi: 10.1007/s42770-020-00322-0. Epub 2020 Jun 27.
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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.
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 study testing Candida antigen in people with 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 27 May 2020. 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 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.
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?
Resolution of warts (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04399577, which also lists 1 linked publication.
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 27 May 2020.