CelAgace™ OraRinse Solution for Treatment of Candidiasis

CelaCare Technologies

Status and phase

Not yet enrolling

Phase 2

Phase 1

Conditions

Candidiasis, Oral

Treatments

Drug: silver citrate complex and acemannan

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03250923

IRB2017-0042

Details and patient eligibility

About

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.

Full 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.

Enrollment

15 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)