WartsPhase 2NCT02567149
Intralesional Cidofovir for the Treatment of Recalcitrant Warts in the Pediatric Immune-suppressed Population.
A Phase 2 study testing Cidofovir in people with Warts, run by University of Minnesota at 1 site in United States.
Trial summary
The primary objective is to determine whether intralesional cidofovir is effective at bringing about the total or near-total resolution of warts that have already proven recalcitrant to standard therapy. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Warts
- What is being tested?
- Cidofovir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to Jun 2016
- 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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 1. The first cohort will include a total of 4 patients ages 12 to 17. After all tests indicate treatment safety, the second cohort will be recruited and will include patients ages 8 to 17.Patient is in immune-suppressed status by one of the following:
- Primary immunodeficiency, which may include but is not limited to the following:
- Chronic Granulomatous Disease (CGD)
- Common Variable Immunodeficiency (CVID)
- DiGeorge Syndrome (DGS)
- Selective IgA Deficiency
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- Severe Combined Immunodeficiency (SCID)
- X-Linked Agammaglobulinemia (XLA)
- Pharmacologic immune-suppressed status from medications including but not limited to:
- prednisone
- cyclosporine
- azathioprine
- tacrolimus/ FK506
- mycophenolate mofetil
- sirolimus
- 2. Patient has history of clinically-significant warts that are either refractory to standard therapy or for which standard therapy is contra-indicated or unreasonable 3. Patient has a total wart burden of at least 1cm 4. Patients must have tried and failed at least 2 other conventional treatments for cutaneous warts, including but not limited to:
- cryotherapy
- topical salicylic acid
- imiquimod
- topical 5FU
- pulsed dye laser therapy
- sinecatechins
- tretinoin or other topical retinoid
- intralesional candida injection
- bleomycin
- electrocautery
- topical cidofovir cream or gel
- There will be a one month washout period for all treatment modalities, with the exception of intralesional candida, which will be 3 months.
- 5. Patient desires ongoing treatment of their warts 6. Patient and/or their parent/guardian consents to participating in this study
Who cannot join
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- Treatment area is either ulcerated, secondarily infected, or significantly inflamed
- Treatment area is on face or groin area
- Patient is pregnant, attempting to become pregnant, or lactating
- Patient reports active kidney disease, or chart review reveals recent serum creatinine ≥1.5mg/dL or a history of renal disease/insufficiency or history of diabetes
- Patient is currently receiving a nephrotoxic medication
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- Patient has history of hypersensitivity to cidofovir
- Patient is severely ill and/or hospitalized
- Patient is receiving chemotherapy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota Medical Center
Minneapolis, Minnesota, 55455
About this study
The primary objective is to determine whether intralesional cidofovir is effective at bringing about the total or near-total resolution of warts that have already proven recalcitrant to standard therapy.
The secondary objective is to determine the tolerability of this new mode of administration of cidofovir in the pediatric population
Read the detailed description
This study includes pediatric patients with history of either primary or iatrogenic immune-suppression who are seeking treatment of warts that have already proven recalcitrant to standard therapy. The first cohort will include 4 patients ages 12 to 17. After all tests indicate treatment safety, the second cohort will be recruited and will include patients ages 8 to 17.
- Conditions
- Warts
- Being tested
- Cidofovir
- Keywords
- Wart
- Medical subject headings
- Warts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CidofovirDrug
Cidofovir
| Study group | Role | What they receive |
|---|---|---|
| Cidofovir | Experimental | Cidofovir clinical resolution of treated warts as evaluated by the investigators Receives: Drug: Cidofovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical resolution of treated warts as evaluated by the investigators
Total or near-total clinical resolution of treated warts as evaluated by the investigators
Measured: 6 months
Improvement of wart-associated symptoms
- Patient-perceived improvement of wart-associated symptoms
Measured: 6 months
Secondary outcomes (1)
Patient/parent reported tolerability of the treatment
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 posted2 Oct 2015 (estimated)
- Study startJun 2016
- Primary completionJun 2016
- Study completionJun 2016
Why it stopped: No funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WartsStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ingrid Polcari, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02567149
- Sponsor's protocol ID
- Version 1.0
- Status last verified
- Jun 2017
- First submitted
- 30 Sep 2015
- Last updated
- 2 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intralesional Cidofovir for the Treatment of Recalcitrant Warts in the Pediatric Immune-suppressed Population.
- ClinicalTrials.gov ID
- NCT02567149
- Acronym / sponsor ID
- Version 1.0
- Conditions
- Warts
- Keywords
- Wart
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 2 Oct 2015 (estimated)
- 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 primary objective is to determine whether intralesional cidofovir is effective at bringing about the total or near-total resolution of warts that have already proven recalcitrant to standard therapy.
The secondary objective is to determine the tolerability of this new mode of administration of cidofovir in the pediatric population
Detailed description
This study includes pediatric patients with history of either primary or iatrogenic immune-suppression who are seeking treatment of warts that have already proven recalcitrant to standard therapy. The first cohort will include 4 patients ages 12 to 17. After all tests indicate treatment safety, the second cohort will be recruited and will include patients ages 8 to 17.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cidofovir | Experimental | Drug: CidofovirCidofovir clinical resolution of treated warts as evaluated by the investigators |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (29 listed)
- 1. The first cohort will include a total of 4 patients ages 12 to 17. After all tests indicate treatment safety, the second cohort will be recruited and will include patients ages 8 to 17.Patient is in immune-suppressed status by one of the following:
- 2. Patient has history of clinically-significant warts that are either refractory to standard therapy or for which standard therapy is contra-indicated or unreasonable 3. Patient has a total wart burden of at least 1cm 4. Patients must have tried and failed at least 2 other conventional treatments for cutaneous warts, including but not limited to:
- There will be a one month washout period for all treatment modalities, with the exception of intralesional candida, which will be 3 months.
- 5. Patient desires ongoing treatment of their warts 6. Patient and/or their parent/guardian consents to participating in this study
Key exclusion criteria (9 listed)
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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 |
|---|---|---|
| CidofovirCidofovir | Drug | Cidofovir |
Primary outcome
Clinical resolution of treated warts as evaluated by the investigators
Time frame: 6 months
Total or near-total clinical resolution of treated warts as evaluated by the investigators
Improvement of wart-associated symptoms
Time frame: 6 months
2. Patient-perceived improvement of wart-associated symptoms
1 secondary outcome
Patient/parent reported tolerability of the treatment
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- 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.
Ingrid Polcari, MD principal investigator
University of Minnesota
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 Cidofovir in people with Warts, run by University of Minnesota at 1 site in United States.
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 29 inclusion and 9 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: withdrawn, as of the sponsor's last update on 2 Jul 2017. 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Clinical resolution of treated warts as evaluated by the investigators (time frame: 6 months). 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 2 Jul 2017.