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CelAgace™ OraRinse (CAOR) Pilot Clinical Study for Management of Candidiasis Associated With Grade 0-II Mucositis
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.
Details
| Lead sponsor | CelaCare Technologies, Inc. |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | UNKNOWN |
| Enrolment | 15 |
| Start date | 2024-09 |
| Completion | 2025-05 |
Conditions
- Candidiasis, Oral
Interventions
- silver citrate complex and acemannan
Primary outcomes
- Clinical cure as demonstrated by change and reduction from baseline in typical candida lesions and a negative candida rinse culture — Days 1(Baseline), 3, 7 and 14
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.
Countries
United States