CelAgace™ OraRinse Solution for Treatment of Candidiasis (NCT03250923) | Clinical Trial Compass
UnknownPhase 1/2
CelAgace™ OraRinse Solution for Treatment of Candidiasis
United States15 participantsStarted 2024-09
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Clinical cure as demonstrated by change and reduction from baseline in typical candida lesions and a negative candida rinse culture