CelAgace™ OraRinse Solution for Treatment of Candidiasis

Candidiasis, Oral Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03250923
• Other study ID #: IRB2017-0042
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: September 2024
• Est. completion date: May 2025

Study information

• Verified date: February 2023
• Source: CelaCare Technologies, Inc.
• Contact: Jacqueline M. Plemons, DDS, MS
• Phone: 214-828-8467
• Email: jplemons[@]tamhsc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: May 2025
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Radiation induced oral mucositis with resulting candidiasis
• Chemotherapy induced oral mucositis with resulting candidiasis
• Oral mucositis due to being immunocompromised with resulting candidiasis
• Stomatitis due to other causes with resulting candidiasis
• Currently have mild to moderate mucositis Exclusion Criteria:

Patient:

• under the age of 18
• pregnant or breastfeeding
• inability to use an oral rinse
• hypersensitivity to Aloe Vera and/or Silver
• whose candida rinse culture was performed greater than 10 days prior to study entry.
• has any sort of removable dental appliance
• with previous or current history of any cancer of the oral cavity
• who received therapy for candidiasis within the past 30 days
• who used antifungal medication in the last 30 days
• who has severe to life threatening oral muositis (Grade III-IV) oral mucositis
• with impaired renal or hepatic function
• receiving high dose chemotherapy and total body irradiation in preparation for Hemopoietic Stem Cell Transplant (HSCT) or Concomitant use of Kepivance® (palifermin or rhKGF)

Related Conditions & MeSH terms

• Candidiasis
• Candidiasis, Oral

Intervention

Drug:
• silver citrate complex and acemannan
Oral rinse solution with each dose containing 100µg silver citrate complex and 40mg acemannan

Locations

Country	Name	City	State
United States	Texas A&M University College of Dentistry	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
CelaCare Technologies, Inc.	Texas A&M University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical cure as demonstrated by change and reduction from baseline in typical candida lesions and a negative candida rinse culture	Rinse culture will be taken on Days 1, 7 and 14 to quantify Candidal Colony Forming Units and observational assessment will be done at study entry, Day 1, Days 3, 7, 14 using the WHO grading scale for response evaluation.	Days 1(Baseline), 3, 7 and 14
Secondary	Reduction in Pain	Patients will complete a pain quality assessment rating scale (PQAS) during the course of the study.	Days 1, 3, 7, 14