CelAgace™ OraRinse Solution for Treatment of Candidiasis

• Status: Not yet recruiting
• Trial end date: 2022-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CelaCare Technologies, Inc.
• Collaborator: Texas A&M University
• Treatments: Acemannan; Citric Acid; Pharmaceutical Solutions

Criteria

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)