Back to resultsCelAgace™ OraRinse Solution for Treatment of Candidiasis
Primary Purpose
Candidiasis, Oral
Status
Not yet recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
silver citrate complex and acemannan
Sponsored by
About this trial
This is an interventional treatment trial for Candidiasis, Oral focused on measuring Oral Candidiasis, Thrush, Oral Moniliasis
Eligibility 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)
Sites / Locations
- Texas A&M University College of Dentistry
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
silver citrate complex and acemannan
Arm Description
This is a single arm open pilot trial. All participants will receive study drug.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Reduction in Pain
Patients will complete a pain quality assessment rating scale (PQAS) during the course of the study.
Full Information
NCT ID
NCT03250923
First Posted
August 10, 2017
Last Updated
February 7, 2023
Sponsor
CelaCare Technologies, Inc.
Collaborators
Texas A&M University
1. Study Identification
Unique Protocol Identification Number
NCT03250923
Brief Title
CelAgace™ OraRinse Solution for Treatment of Candidiasis
Official Title
CelAgace™ OraRinse (CAOR) Pilot Clinical Study for Management of Candidiasis Associated With Grade 0-II Mucositis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
November 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CelaCare Technologies, Inc.
Collaborators
Texas A&M University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Candidiasis, Oral
Keywords
Oral Candidiasis, Thrush, Oral Moniliasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
silver citrate complex and acemannan
Arm Type
Experimental
Arm Description
This is a single arm open pilot trial. All participants will receive study drug.
Intervention Type
Drug
Intervention Name(s)
silver citrate complex and acemannan
Other Intervention Name(s)
CelAgace™ OraRinse Solution
Intervention Description
Oral rinse solution with each dose containing 100μg silver citrate complex and 40mg acemannan
Primary Outcome Measure Information:
Title
Clinical cure as demonstrated by change and reduction from baseline in typical candida lesions and a negative candida rinse culture
Description
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.
Time Frame
Days 1(Baseline), 3, 7 and 14
Secondary Outcome Measure Information:
Title
Reduction in Pain
Description
Patients will complete a pain quality assessment rating scale (PQAS) during the course of the study.
Time Frame
Days 1, 3, 7, 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jacqueline M. Plemons, DDS, MS
Phone
214-828-8467
Email
jplemons@tamhsc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Celeste M. Abraham, DDS, MS
Phone
214-828-8467
Email
cabraham@tamhsc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacqueline M. Plemons, DDS, MS
Organizational Affiliation
Texas A&M University College of Dentistry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Texas A&M University College of Dentistry
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacqueline M. Plemons, DDS, MS
Phone
214-828-8467
Email
jplemons@tamhsc.edu
First Name & Middle Initial & Last Name & Degree
Celeste M. Abraham, DDS, MS
Phone
214-828-8467
Email
cabraham@tamhsc.edu
First Name & Middle Initial & Last Name & Degree
Celeste M. Abraham, DDS, MS
First Name & Middle Initial & Last Name & Degree
Jacqueline M. Plemons, DDS, MS
12. IPD Sharing Statement
Learn more about this trial
CelAgace™ OraRinse Solution for Treatment of Candidiasis
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