CelAgace™ OraRinse Solution for Treatment of Candidiasis
| Status: | Not yet recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/27/2018 |
| Start Date: | February 2018 |
| End Date: | May 2018 |
| Contact: | Jacqueline M. Plemons, DDS, MS |
| Email: | jplemons@tamhsc.edu |
| Phone: | 214-828-8467 |
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 being evaluated for
safety and effectiveness as a potential treatment for candidiasis, a yeast infection,
commonly known as thrush, which is associated with mouth sores. CelAgace™ contains two active
ingredients, a silver citrate complex salt that has demonstrated laboratory effectiveness
against yeast organisms and acemannan, 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.
safety and effectiveness as a potential treatment for candidiasis, a yeast infection,
commonly known as thrush, which is associated with mouth sores. CelAgace™ contains two active
ingredients, a silver citrate complex salt that has demonstrated laboratory effectiveness
against yeast organisms and acemannan, 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.
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)
We found this trial at
1
site
3302 Gaston Avenue
Dallas, Texas 75246
Dallas, Texas 75246
Phone: 214-828-8467
Click here to add this to my saved trials
