Carrageenan for the Prevention of Oral HPV Infection

McGill University

Status: Enrolling

Conditions: Human Papilloma Virus

Treatments: Other: Mouthwash gargling

Study type: Interventional

Funder types: Other

Identifiers

NCT05746988

A03-M01-22A

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups, including a placebo group

Carrageenan-based Mouthwash

Experimental group

Description:

Mouthwash with Carrageenan as an active ingredient

Treatment:

Other: Mouthwash gargling

Placebo Mouthwash

Placebo Comparator group

Description:

Mouthwash without Carrageenan but similar in colour, taste, and "mouthfeel" to the experimental mouthwash

Treatment:

Other: Mouthwash gargling