Nitric Oxide Releasing Mouthwash (NORM) for the Management of

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06120816
Study type	Interventional
Source	Sanotize Research and Development corp.
Contact
Status	Active, not recruiting
Phase	Phase 1
Start date	January 20, 2024
Completion date	August 30, 2024

View Details

See also
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