CelAgace™ OraRinse Solution for Treatment of Candidiasis
Study Details
Study Description
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 as thrush, which is associated with mouth sores.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
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 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: silver citrate complex and acemannan This is a single arm open pilot trial. All participants will receive study drug. |
Drug: silver citrate complex and acemannan
Oral rinse solution with each dose containing 100μg silver citrate complex and 40mg acemannan
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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.
Secondary Outcome Measures
- Reduction in Pain [Days 1, 3, 7, 14]
Patients will complete a pain quality assessment rating scale (PQAS) during the course of the study.
Eligibility Criteria
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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Texas A&M University College of Dentistry | Dallas | Texas | United States | 75246 |
Sponsors and Collaborators
- CelaCare Technologies, Inc.
- Texas A&M University
Investigators
- Principal Investigator: Jacqueline M. Plemons, DDS, MS, Texas A&M University College of Dentistry
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB2017-0042