Palmar or Plantar WartsPhase 3VAC-WARTSNCT04814446
Nonavalent HPV Vaccine in the Treatment of Difficult-to-treat Palmo-plantar Warts
A Phase 3 study testing Vaccination in people with Palmar or Plantar Warts, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Cutaneous viral warts are very common and are caused by the human papilloma virus (HPV). Most people experience warts in one form or another at some point in their lives. Cutaneous warts are related to different types of HPV. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Palmar or Plantar Warts
- What is being tested?
- Vaccination
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 146 participants
- Where
- 1 siteFrance
- Study dates
- 29 Jun 2022to 29 Jun 2026
- Phase
- Phase 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients of age ≥ 15 years and 3 months with palmar or plantar warts (including periungueal and back of hands or feet warts) since more than one year with:
- ≥ 5 warts (X palmar and X plantar) or
- ≥ 4 cm2 of Total surface involved by the warts (Y cm x Z cm).
- Patients should have received two lines of treatment during the past year before inclusion, the last treatment must be at 3 weeks maximum before inclusion:
- At total one month of application of topical salicylic acid, with minimum 3 weeks continuous.
- At least two sprays of liquid nitrogen (two applications at the same session, or at different sessions with a few intervals).
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- Painful warts (VAS ≥ 4) or functional discomfort (Revised foot function index (RFFI) or Cochin Hand Function Scale (CHSF) or social discomfort (DLQI)).
- No topical or systemic immunosuppresive/ immunomodulating drugs
- Women of childbearing potential must have a negative pregnancy test and an effective contraception (V1) and up the end of the vaccination period of 6 months;
- Individuals affiliated to a social security regimen;
- Individuals able to participate and to follow up during the study period.
Who cannot join
- Suspicion of COVID, with confirmation by autotest.
- Any causes of immunosupression: organ transplant recipients, bone-marrow transplantation, immunosupressive regimens for any diseases, HIV positivity.
- Women or men who received HPV Vaccine previously of the study;
- Any serious chronic or progressive disease according to the judgement of the investigator;
- Individuals with history of known allergies/hypersensitivity to any component of study vaccine;
- Individuals who have any malignancy or lymphoproliferative disorder;
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- Individuals with thrombocytopenia or coagulation disorder contre-indicating intramusculary injections;
- Patient with anticoagulant therapy
- Individuals with body temperature > 38.0 degrees Celsius or/and acute disease within 3 days of intended study vaccination;
- Women who are pregnant or are breast-feeding, or are of childbearing age who have not used or do not plan to use acceptable birth control measures, during the first 6 months ½ of the study;
- Individuals under a measure of legal protection or unable to consent;
- Individuals participating in any clinical trial with another investigational product 28 days prior to first study visit or intent to participate in another clinical study at any time during the conduct of the study.
- Participation in another interventional study involving human participants or being in the exclusion period at the end of a previous study involving human participants, if applicable
- Patient on AME (state medical aid) (unless exemption from affiliation).
- Patient wishing to be vaccinated with Gardasil 9® within 6 months or refusing the principle of postponing vaccination.
- Immunosuppressive therapy including use of systemic corticosteroids or chronic immunosuppressant medication (more than 14 days)
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hospital Cochin
Paris, 75014
Johan CHANAL, Dr, +33 1 58 41 18 25, johan.chanal@aphp.fr
About this study
Official title: Efficacy of the Nonavalent HPV Vaccine in the Treatment of Difficult-to-treat Palmo-plantar Warts
Cutaneous viral warts are very common and are caused by the human papilloma virus (HPV). Most people experience warts in one form or another at some point in their lives. Cutaneous warts are related to different types of HPV. For the palms and soles, HPV 2 has been the most frequently found but HPV 1, 4, 27, and 57 have also been described. Our hypothesis is that vaccination by nonavalent vaccine against HPV could lead to a complete resolution of difficult-to-treat palmo-plantar warts patients of more than 15 years and 3 months of age.
Read the detailed description
The qHPV and nHPV has been used as a therapeutic approached for the treatment of cutaneous warts in case reports and some case series. Very recently, the Journal of the American Academy of Dermatology (JAAD)-the journal with the highest impact factor in the dermatological field- has published a review of all the cases reported in the scientific literature. The authors were strongly in favor of the use of the vaccine in case of difficult-to-treat warts and have highlighted the need for clinical trials. In the literature, 80 patients have been described with cutaneous warts treated by qHPV or nHPV with more than 50% of efficacy.Our hypothesis is that vaccination by nonavalent vaccine against HPV could lead to a complete resolution of difficult-to-treat palmo-plantar warts patients of more than 15 years and 3 months of age.
- Conditions
- Palmar or Plantar Warts
- Being tested
- Vaccination
- Keywords
- WARTS, Vaccine HPV
- Medical subject headings
- Warts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VaccinationBiological
Intramuscular injections of 0,5 ml will be administered at M0, M2 and M6
| Study group | Role | What they receive |
|---|---|---|
| Gardasil 9® | Experimental | Nonavalent HPV vaccine Receives: Biological: Vaccination |
| Placebo | Placebo comparator | NaCl 0.9 % solution for injection Receives: Biological: Vaccination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete remission of cutaneous warts
Complete remission of cutaneous warts 7 months after the first injection of the vaccine
Measured: 7 months
Secondary outcomes (5)
Quality of Life evaluated
Quality of Life will be evaluated with QoL Questionnaire (DLQI)
Measured: Inclusion, 2 months, 6 months, 7 months
Pain (VAS)
Pain will be assess using VAS
Measured: Inclusion, 2 months, 6 months, 7 months
Functional discomfort for walking and functional disability in hands
Functional discomfort for walking and functional disability in hands will be evaluated using the Revised Foot Function index or Cochin hand function scale respectively at M0, M2, M6, M7.
Measured: Inclusion, 2 months, 6 months, 7 months
Partial remission of cutaneous warts
Partial remission of cutaneous warts 7 months after the first injection of the vaccine.
Measured: 7 months
Number of warts appeared
Number of warts appeared at M2, M6, M7
Measured: Inclusion, 2 months, 6 months, 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start29 Jun 2022
- Primary completion29 Jun 2025 (estimated)
- Study completion29 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palmar or Plantar WartsStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter national clinical trial, phase III, two parallel group randomized (in a 1:1 ratio)
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Johan CHANAL, Dr, Principal investigator, Hospital CochinOlivier CHOSIDOW, Pr, Study director, Henri Mondor University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04814446
- Sponsor's protocol ID
- APHP200046
- Other IDs
- 2024-513671-40-00
- Acronym
- VAC-WARTS
- Status last verified
- Jan 2024
- First submitted
- 22 Mar 2021
- Last updated
- 23 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the Nonavalent HPV Vaccine in the Treatment of Difficult-to-treat Palmo-plantar Warts
- ClinicalTrials.gov ID
- NCT04814446
- Acronym / sponsor ID
- VAC-WARTS / APHP200046
- Conditions
- Palmar or Plantar Warts
- Keywords
- WARTS, Vaccine HPV
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 29 Jun 2022 (actual)
- Primary completion
- 29 Jun 2025 (estimated)
- Study completion
- 29 Jun 2026 (estimated)
- First posted
- 24 Mar 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.
Cutaneous viral warts are very common and are caused by the human papilloma virus (HPV). Most people experience warts in one form or another at some point in their lives. Cutaneous warts are related to different types of HPV. For the palms and soles, HPV 2 has been the most frequently found but HPV 1, 4, 27, and 57 have also been described. Our hypothesis is that vaccination by nonavalent vaccine against HPV could lead to a complete resolution of difficult-to-treat palmo-plantar warts patients of more than 15 years and 3 months of age.
Detailed description
The qHPV and nHPV has been used as a therapeutic approached for the treatment of cutaneous warts in case reports and some case series. Very recently, the Journal of the American Academy of Dermatology (JAAD)-the journal with the highest impact factor in the dermatological field- has published a review of all the cases reported in the scientific literature. The authors were strongly in favor of the use of the vaccine in case of difficult-to-treat warts and have highlighted the need for clinical trials. In the literature, 80 patients have been described with cutaneous warts treated by qHPV or nHPV with more than 50% of efficacy.Our hypothesis is that vaccination by nonavalent vaccine against HPV could lead to a complete resolution of difficult-to-treat palmo-plantar warts patients of more than 15 years and 3 months of age.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Multicenter national clinical trial, phase III, two parallel group randomized (in a 1:1 ratio)
| Arm | Type | Receives |
|---|---|---|
| Gardasil 9® | Experimental | Biological: VaccinationNonavalent HPV vaccine |
| Placebo | Placebo comparator | Biological: VaccinationNaCl 0.9 % solution for injection |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Patients of age ≥ 15 years and 3 months with palmar or plantar warts (including periungueal and back of hands or feet warts) since more than one year with:
- ≥ 5 warts (X palmar and X plantar) or
- ≥ 4 cm2 of Total surface involved by the warts (Y cm x Z cm).
- Patients should have received two lines of treatment during the past year before inclusion, the last treatment must be at 3 weeks maximum before inclusion:
- At total one month of application of topical salicylic acid, with minimum 3 weeks continuous.
Key exclusion criteria (16 listed)
- Suspicion of COVID, with confirmation by autotest.
- Any causes of immunosupression: organ transplant recipients, bone-marrow transplantation, immunosupressive regimens for any diseases, HIV positivity.
- Women or men who received HPV Vaccine previously of the study;
- Any serious chronic or progressive disease according to the judgement of the investigator;
- Individuals with history of known allergies/hypersensitivity to any component of study vaccine;
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 |
|---|---|---|
| VaccinationIntramuscular injections of 0,5 ml will be administered at M0, M2 and M6 | Biological | Gardasil 9®, Placebo |
Primary outcome
Complete remission of cutaneous warts
Time frame: 7 months
Complete remission of cutaneous warts 7 months after the first injection of the vaccine
5 secondary outcomes
Quality of Life evaluated
Time frame: Inclusion, 2 months, 6 months, 7 months
Pain (VAS)
Time frame: Inclusion, 2 months, 6 months, 7 months
Functional discomfort for walking and functional disability in hands
Time frame: Inclusion, 2 months, 6 months, 7 months
Partial remission of cutaneous warts
Time frame: 7 months
Number of warts appeared
Time frame: Inclusion, 2 months, 6 months, 7 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2025.
- Individual participant dataSharing planned: No
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.
Johan CHANAL, Dr principal investigator
Hospital Cochin
Olivier CHOSIDOW, Pr study director
Henri Mondor University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vaccination in people with Palmar or Plantar Warts, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 11 inclusion and 16 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 23 Jan 2025. 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 France. 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. Some participants in this study may receive a placebo. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Johan CHANAL, Dr (+33 1 58 41 18 25, johan.chanal@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete remission of cutaneous warts (time frame: 7 months). 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 23 Jan 2025.