Candidiasis, OralPhase 1/2NCT03250923
CelAgace™ OraRinse Solution for Treatment of Candidiasis
A Phase 1/2 study testing silver citrate complex and acemannan in people with Candidiasis, Oral, run by CelaCare Technologies, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Candidiasis, Oral
- What is being tested?
- silver citrate complex and acemannan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2024to May 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas A&M University College of Dentistry
Dallas, Texas, 75246
Jacqueline M. Plemons, DDS, MS, 214-828-8467, jplemons@tamhsc.edu
Celeste M. Abraham, DDS, MS, 214-828-8467, cabraham@tamhsc.edu
About this study
Official title: 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 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.
Read the 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.
- Conditions
- Candidiasis, Oral
- Being tested
- silver citrate complex and acemannan
- Keywords
- Oral Candidiasis, Thrush, Oral Moniliasis
- Medical subject headings
- Candidiasis, Oral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
silver citrate complex and acemannanDrug
Also called CelAgace™ OraRinse Solution
Oral rinse solution with each dose containing 100μg silver citrate complex and 40mg acemannan
| Study group | Role | What they receive |
|---|---|---|
| silver citrate complex and acemannan | Experimental | This is a single arm open pilot trial. All participants will receive study drug. Receives: Drug: silver citrate complex and acemannan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Days 1(Baseline), 3, 7 and 14
Secondary outcomes (1)
Reduction in Pain
Patients will complete a pain quality assessment rating scale (PQAS) during the course of the study.
Measured: Days 1, 3, 7, 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2017
- Study startSep 2024 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Candidiasis, OralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CelaCare Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Texas A&M University
- Responsible party
- Sponsor
- Investigators
- Jacqueline M. Plemons, DDS, MS, Principal investigator, Texas A&M University College of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03250923
- Sponsor's protocol ID
- IRB2017-0042
- Status last verified
- Feb 2023
- First submitted
- 10 Aug 2017
- Last updated
- 9 Feb 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CelAgace™ OraRinse (CAOR) Pilot Clinical Study for Management of Candidiasis Associated With Grade 0-II Mucositis
- ClinicalTrials.gov ID
- NCT03250923
- Acronym / sponsor ID
- IRB2017-0042
- Conditions
- Candidiasis, Oral
- Keywords
- Oral Candidiasis, Thrush, Oral Moniliasis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- CelaCare Technologies, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Texas A&M University
- Study start
- Sep 2024 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 16 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| silver citrate complex and acemannan | Experimental | Drug: silver citrate complex and acemannanThis is a single arm open pilot trial. All participants will receive study drug. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| silver citrate complex and acemannanAlso: CelAgace™ OraRinse SolutionOral rinse solution with each dose containing 100μg silver citrate complex and 40mg acemannan | Drug | silver citrate complex and acemannan |
Primary outcome
Clinical cure as demonstrated by change and reduction from baseline in typical candida lesions and a negative candida rinse culture
Time frame: 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.
1 secondary outcome
Reduction in Pain
Time frame: Days 1, 3, 7, 14
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacqueline M. Plemons, DDS, MS principal investigator
Texas A&M University College of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing silver citrate complex and acemannan in people with Candidiasis, Oral, run by CelaCare Technologies, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jacqueline M. Plemons, DDS, MS (214-828-8467, jplemons@tamhsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical cure as demonstrated by change and reduction from baseline in typical candida lesions and a negative candida rinse culture (time frame: Days 1(Baseline), 3, 7 and 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2024.