Human Papilloma VirusNCT05746988
Carrageenan for the Prevention of Oral HPV Infection
A study testing Mouthwash gargling in people with Human Papilloma Virus, run by McGill University at 1 site in Canada.
Trial summary
This is a placebo-controlled, triple-blind randomized clinical trial (RCT) designed to evaluate the feasibility of conducting a larger multicentric RCT investigating the effect of a Carrageenan mouthwash on oral HPV infection. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Human Papilloma Virus
- What is being tested?
- Mouthwash gargling
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 26 May 2023to Mar 2024
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged between 18 and 45 years old
- Sexually active and have had oral sex in the past month
- Will be residing in Montreal for the next six (6) months after study enrolment
Who cannot join
- Previous vaccination against HPV
- Previous cancer of the mouth or throat
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
McGill University
Montreal, Quebec, H3G 1Y6
Belinda Nicolau, PhD, 1-514-398-7203 ext. 09465, belinda.nicolau@mcgill.ca
Babatunde Alli, BDS, MSc, babatunde.alli@mcgill.ca
About this study
Official title: Carrageenan for the Prevention of Oral HPV Infection: a Feasibility, Randomized Clinical Trial
This is a placebo-controlled, triple-blind randomized clinical trial (RCT) designed to evaluate the feasibility of conducting a larger multicentric RCT investigating the effect of a Carrageenan mouthwash on oral HPV infection. Eligible participants will complete a single in-person visit at baseline, filling out a questionnaire on their electronic device and giving an oral rinse sample for HPV testing. They will receive an adequate supply of mouthwash and instructions on its use. They will subsequently be followed up for up to six months. Every two weeks, participants will fill out a follow-up questionnaire on mouthwash use and sexual activities and self-collect oral rinse sample to be returned by mail.
- Conditions
- Human Papilloma Virus
- Being tested
- Mouthwash gargling
- Keywords
- Oral HPV infection, Mouthwash, Carrageenan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mouthwash garglingOther
15 - 20 ml of mouthwash to be gargled vigorously for 30 to 60 seconds daily (morning and night) as an adjunct to regular toothbrushing, and before and/or immediately after sexual activities.
| Study group | Role | What they receive |
|---|---|---|
| Carrageenan-based Mouthwash | Experimental | Mouthwash with Carrageenan as an active ingredient Receives: Other: Mouthwash gargling |
| Placebo Mouthwash | Placebo comparator | Mouthwash without Carrageenan but similar in colour, taste, and "mouthfeel" to the experimental mouthwash Receives: Other: Mouthwash gargling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
This will be measured by the total number of participants recruited into the study. The investigators intend to recruit 40 participants. Recruitment rate will be calculated as number of participants per month.
Measured: 1 year
Drop-out rate
The proportion of individuals who enrolled into the study but left before the end of the study will be documented.
Measured: 1 year
Adherence rate for mouthwash use
This will be calculated as the proportion of participants who completed the study and complied with the mouthwash use regimen.
Measured: 6 months
Adherence rate for self-sampling
This will be calculated as the proportion of participants who completed the study and complied with the bi-weekly self-sampling procedure
Measured: 6 month
Acceptability of study procedures as assessed by satisfaction on a Visual Analog Scale
Qualitative and quantitative assessment will be used to evaluate participants' experience with the RCT through the follow-up questionnaire and an exit question. Participants will be asked to rate their satisfaction with the study procedure on a scale of 1-10 (10 being the highest satisfaction level). This will focus on level of satisfaction of the participants with mouthwash use around sexual activities and the level of satisfaction of the participants with the biweekly self-sampling.
Measured: 6 months
Secondary outcomes (1)
Mouthwash safety (Pain score) as assessed by the Visual Analog Scale
The mean pain score (for any pain ascribed to the mouthwash e.g., burning mouth, recurrent aphthous stomatitis e.t.c.) measured on the VAS (1-10; 10 being the worst pain) will be recorded.
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 posted28 Feb 2023
- Study start26 May 2023
- Primary completionDec 2023 (estimated)
- Study completionMar 2024 (estimated)
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 Human Papilloma VirusStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Belinda Nicolau, McGill University
- Investigators
- Belinda Nicolau, DDS, PhD, Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05746988
- Sponsor's protocol ID
- A03-M01-22A
- Status last verified
- Jun 2023
- First submitted
- 17 Jan 2023
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alli BY, Madathil S, Tran SD, Nicolau B. Protocol: carrageenan for the prevention of oral HPV infection - a feasibility randomised clinical trial. BMJ Open. 2023 Jul 27;13(7):e074498. doi: 10.1136/bmjopen-2023-074498.
PubMed 37500273
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carrageenan for the Prevention of Oral HPV Infection: a Feasibility, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05746988
- Acronym / sponsor ID
- A03-M01-22A
- Conditions
- Human Papilloma Virus
- Keywords
- Oral HPV infection, Mouthwash, Carrageenan
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Study start
- 26 May 2023 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 28 Feb 2023 (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 is a placebo-controlled, triple-blind randomized clinical trial (RCT) designed to evaluate the feasibility of conducting a larger multicentric RCT investigating the effect of a Carrageenan mouthwash on oral HPV infection. Eligible participants will complete a single in-person visit at baseline, filling out a questionnaire on their electronic device and giving an oral rinse sample for HPV testing. They will receive an adequate supply of mouthwash and instructions on its use. They will subsequently be followed up for up to six months. Every two weeks, participants will fill out a follow-up questionnaire on mouthwash use and sexual activities and self-collect oral rinse sample to be returned by mail.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carrageenan-based Mouthwash | Experimental | Other: Mouthwash garglingMouthwash with Carrageenan as an active ingredient |
| Placebo Mouthwash | Placebo comparator | Other: Mouthwash garglingMouthwash without Carrageenan but similar in colour, taste, and "mouthfeel" to the experimental mouthwash |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Aged between 18 and 45 years old
- Sexually active and have had oral sex in the past month
- Will be residing in Montreal for the next six (6) months after study enrolment
Key exclusion criteria (2 listed)
- Previous vaccination against HPV
- Previous cancer of the mouth or throat
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 |
|---|---|---|
| Mouthwash gargling15 - 20 ml of mouthwash to be gargled vigorously for 30 to 60 seconds daily (morning and night) as an adjunct to regular toothbrushing, and before and/or immediately after sexual activities. | Other | Carrageenan-based Mouthwash, Placebo Mouthwash |
Primary outcome
Recruitment rate
Time frame: 1 year
This will be measured by the total number of participants recruited into the study. The investigators intend to recruit 40 participants. Recruitment rate will be calculated as number of participants per month.
Drop-out rate
Time frame: 1 year
The proportion of individuals who enrolled into the study but left before the end of the study will be documented.
Adherence rate for mouthwash use
Time frame: 6 months
This will be calculated as the proportion of participants who completed the study and complied with the mouthwash use regimen.
Adherence rate for self-sampling
Time frame: 6 month
This will be calculated as the proportion of participants who completed the study and complied with the bi-weekly self-sampling procedure
Acceptability of study procedures as assessed by satisfaction on a Visual Analog Scale
Time frame: 6 months
Qualitative and quantitative assessment will be used to evaluate participants' experience with the RCT through the follow-up questionnaire and an exit question. Participants will be asked to rate their satisfaction with the study procedure on a scale of 1-10 (10 being the highest satisfaction level). This will focus on level of satisfaction of the participants with mouthwash use around sexual activities and the level of satisfaction of the participants with the biweekly self-sampling.
1 secondary outcome
Mouthwash safety (Pain score) as assessed by the Visual Analog Scale
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Derived from this study: PubMed 37500273Alli BY, Madathil S, Tran SD, Nicolau B. Protocol: carrageenan for the prevention of oral HPV infection - a feasibility randomised clinical trial. BMJ Open. 2023 Jul 27;13(7):e074498. doi: 10.1136/bmjopen-2023-074498.
- Individual participant dataSharing planned: No
Related trials for Human Papilloma Virus
Not yet recruitingPhase 1/2
Clinical Trial to Assess the Safety, Tolerability, Reactogenicity, and Immunogenicity of a 10 Valent Human Papillomavirus Virus (10vHPV) Vaccine
Human Papillomavirus Infection
Active, not recruitingPhase 4
Comparing Immune Response of 2 vs 3 HPV Doses (27-45 Years Old)
Immunization, HPV Infection
Not yet recruitingPhase 2
Combination Bevacizumab and PRGN-2012 in Adults With Recurrent Respiratory Papillomatosis (RRP)
Respiratory Recurrent Papillomatosis (RRP), Human Papillomavirus (HPV)
RecruitingPhase 2
A Study of the Preliminary Efficacy of DARE-HPV to Treat High-risk Persistent Human Papillomavirus (hrHPV)
Human Papilloma Virus (HPV), High-risk Human Papillomavirus Infection
RecruitingPhase 2
A Single Arm Phase II Trial in p16-positive Oropharynx Cancer of Selective Dose De-escalation of nodAl VolumEs at Minimal Risk and Primary Site Disease (SAVED)
Head and Neck Cancer, Head and Neck Squamous Cell Cancer
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.
Belinda Nicolau, DDS, PhD principal investigator
McGill University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mouthwash gargling in people with Human Papilloma Virus, run by McGill University at 1 site in Canada.
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 3 inclusion and 2 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 22 Jun 2023. 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 Canada. 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.
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 Belinda Nicolau, DDS, PhD (1-514-398-7203 ext. 09465, belinda.nicolau@mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: 1 year). The study lists 5 primary outcomes in all. 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 NCT05746988, 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 22 Jun 2023.