CelAgace™ OraRinse Solution for Treatment of Candidiasis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Candidiasis, Oral

Intervention / Treatment
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* Drug: silver citrate complex and acemannan


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: silver citrate complex and acemannan<br>This is a single arm open pilot trial. All participants will receive study drug. | Drug: silver citrate complex and acemannan<br>* Oral rinse solution with each dose containing 100μg silver citrate complex and 40mg acemannan<br>* Other names: CelAgace™ OraRinse Solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in Pain | Patients will complete a pain quality assessment rating scale (PQAS) during the course of the study. | Days 1, 3, 7, 14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oral Candidiasis, Thrush, Oral Moniliasis