Status:
UNKNOWN
CelAgace™ OraRinse Solution for Treatment of Candidiasis
Lead Sponsor:
CelaCare Technologies, Inc.
Collaborating Sponsors:
Texas A&M University
Conditions:
Candidiasis, Oral
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 a...
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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2025
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03250923
Start Date
September 1 2024
End Date
May 1 2025
Last Update
February 9 2024
Active Locations (1)
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1
Texas A&M University College of Dentistry
Dallas, Texas, United States, 75246