Carrageenan for the Prevention of Oral HPV Infection

• Sponsor: McGill University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05746988
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 12.9
• Patients Per Site Per Month: 3.1

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Human Papilloma Virus	Other: Mouthwash gargling	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Carrageenan for the Prevention of Oral HPV Infection: a Feasibility, Randomized Clinical Trial
• Anticipated Study Start Date: Feb 1, 2023
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Mar 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Carrageenan-based Mouthwash Mouthwash with Carrageenan as an active ingredient	Other: Mouthwash gargling; 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.
Placebo Comparator: Placebo Mouthwash Mouthwash without Carrageenan but similar in colour, taste, and "mouthfeel" to the experimental mouthwash	Other: Mouthwash gargling; 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.

Outcome Measures

Primary Outcome Measures

1. Recruitment rate [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.

2. Drop-out rate [1 year]

   The proportion of individuals who enrolled into the study but left before the end of the study will be documented.

3. Adherence rate for mouthwash use [6 months]

   This will be calculated as the proportion of participants who completed the study and complied with the mouthwash use regimen.

4. Adherence rate for self-sampling [6 month]

   This will be calculated as the proportion of participants who completed the study and complied with the bi-weekly self-sampling procedure

5. Acceptability of study procedures as assessed by satisfaction on a Visual Analog Scale [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.

Secondary Outcome Measures

1. Mouthwash safety (Pain score) as assessed by the Visual Analog Scale [6 months]

   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.

Other Outcome Measures

1. Time to oral HPV infection [6 months]

   Time to type-specific oral HPV infection will be recorded for participants with negative type-specific oral HPV status at baseline

2. Time to oral HPV clearance [6 months]

   Time to type-specific oral HPV clearance will be recorded for participants with positive type-specific oral HPV status at baseline

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• 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

Exclusion Criteria:

• Previous vaccination against HPV

• Previous cancer of the mouth or throat

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	McGill University	Montreal	Quebec	Canada	H3G 1Y6

Sponsors and Collaborators

• McGill University

Investigators

• Principal Investigator: Belinda Nicolau, DDS, PhD, McGill University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr. Belinda Nicolau, Professor, McGill University
• ClinicalTrials.gov Identifier: NCT05746988
• Other Study ID Numbers: A03-M01-22A
• First Posted: Feb 28, 2023
• Last Update Posted: Feb 28, 2023
• Last Verified: Feb 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Dr. Belinda Nicolau, Professor, McGill University: Oral HPV infection; Mouthwash; Carrageenan
• Additional relevant MeSH terms: Infections; Papillomavirus Infections; Papilloma

Study Results

No Results Posted as of Feb 28, 2023