NCT03250923

CelAgace™ OraRinse Solution for Treatment of Candidiasis

CelAgace™ OraRinse (CAOR) Pilot Clinical Study for Management of Candidiasis Associated With Grade 0-II Mucositis

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: CelaCare Technologies, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

CelAgace™ OraRinse (silver citrate complex and acemannan) Solution is planned to be evaluated for safety and effectiveness as a potential treatment for candidiasis, a yeast infection, commonly known as thrush, which is associated with mouth sores.

Detailed description

CelAgace™ contains two active ingredients, a silver citrate complex salt (0.01mg/ml) that has demonstrated laboratory effectiveness against yeast organisms and acemannan (4.0mg/ml), a purified extract isolated from the inner leaf gel of the Aloe vera plant that has been used as a key ingredient in other oral care products. Patients will swish and spit the product 4 times daily (after meals and at bedtime) for 14 days. Following an initial office visit, patients will be evaluated on days 7 and 14 to determine response to the product.

Conditions

• Candidiasis, Oral

Interventions

Type	Name	Description
DRUG	silver citrate complex and acemannan	Oral rinse solution with each dose containing 100μg silver citrate complex and 40mg acemannan

Timeline

• Start date: 2024-09-01
• Primary completion: 2024-09-01
• Completion: 2025-05-01
• First posted: 2017-08-16
• Last updated: 2024-02-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study