NCT06120816

Nitric Oxide Releasing Mouthwash (NORM) for the Management of Oropharyngeal Candidiasis

Phase 1 Single Centre, Open-labeled Clinical Trial to Evaluate the Safety and Tolerability of Topical Nitric Oxide Releasing Mouthwash (NORM) for the Management of Oropharyngeal Candidiasis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Sanotize Research and Development corp. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

Phase 1 Single Centre, open-labeled Clinical Trial to Evaluate the Safety and Tolerability of Topical Nitric Oxide Releasing Mouthwash (NORM) for the Management of Oropharyngeal Candidiasis. Participants that meet all inclusion and exclusion criteria will be enrolled to receive open label NORM 3 doses/day for three weeks.

Detailed description

This is a single-center, open-label phase 1 clinical trial to evaluate NORM safety, tolerance and ability to eliminate Candida sp from the oropharyngeal cavity. Adult volunteer patients with dry mouth and confirmed presence of candida (by oral smear due to any cause will be eligible, including autoimmune disease, idiopathic (aging, tobacco, approved inhaled recreational drug, or alcohol use), and medical management including chemotherapy-induced, radiotherapy-induced, bone marrow transplantation-induced, medication use including antibiotics, anti-inflammatories, etc. Sufficient participants will be enrolled to achieve 10 evaluable participants. Participants who are currently pursuing other forms of treatment (within 2 weeks prior to enrollment) will be excluded from the study (unless participant agrees to a two weeks wash out period).

Conditions

• Candidiasis, Oral

Interventions

Type	Name	Description
DRUG	Nitric Oxide	Nitric Oxide Releasing Mouthwash will be self-administered by the participant three times throughout the day for 21 days. The intervention solution will be poured into their mouth from a medication cup containing 20 mL of the solution. Total exposure to study intervention will be a maximum of 63 treatments totaling 1,260 mL. All participants will be monitored for 7 days post-last treatment dose (to Day 28).

Timeline

• Start date: 2024-01-20
• Primary completion: 2024-05-25
• Completion: 2024-05-25
• First posted: 2023-11-07
• Last updated: 2024-07-10

Locations

1 site across 1 country: Canada