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CelAgace™ OraRinse for Oral Thrush

Phase 1 & 2
Waitlist Available
Led By Jacqueline M. Plemons, DDS, MS
Research Sponsored by CelaCare Technologies, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Radiation induced oral mucositis with resulting candidiasis
Stomatitis due to other causes with resulting candidiasis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 1, 3, 7, 14
Awards & highlights

Study Summary

This trial will test a new potential treatment for candidiasis, or thrush. The treatment is a mouth rinse made of silver and a substance called acemannan.

Who is the study for?
This trial is for adults with mild to moderate oral thrush due to immunocompromise or treatments like chemotherapy. It's not for pregnant/breastfeeding individuals, those who can't use an oral rinse, have a history of oral cancer, used antifungals recently, are allergic to Aloe Vera/Silver, wear removable dental appliances, or have severe mouth sores.Check my eligibility
What is being tested?
The trial tests CelAgace™ OraRinse Solution containing silver citrate complex and acemannan for treating candidiasis (oral thrush). The goal is to see if it's safe and effective in healing mouth sores associated with yeast infections.See study design
What are the potential side effects?
Potential side effects may include reactions related to the ingredients such as sensitivity or irritation in the mouth. Since this involves new treatment testing, other unexpected side effects might occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a fungal mouth infection due to radiation treatment.
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I have mouth sores with a yeast infection.
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I have a mouth infection caused by yeast after chemotherapy.
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I have mouth sores and yeast infection due to a weak immune system.
Select...
I currently have mild to moderate mouth sores.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 1, 3, 7, 14
This trial's timeline: 3 weeks for screening, Varies for treatment, and days 1, 3, 7, 14 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clinical cure as demonstrated by change and reduction from baseline in typical candida lesions and a negative candida rinse culture
Secondary outcome measures
Reduction in Pain

Trial Design

1Treatment groups
Experimental Treatment
Group I: silver citrate complex and acemannanExperimental Treatment1 Intervention
This is a single arm open pilot trial. All participants will receive study drug.

Find a Location

Who is running the clinical trial?

CelaCare Technologies, Inc.Lead Sponsor
Texas A&M UniversityOTHER
139 Previous Clinical Trials
23,900 Total Patients Enrolled
Jacqueline M. Plemons, DDS, MSPrincipal InvestigatorTexas A&M University College of Dentistry

Media Library

CelAgace™ OraRinse Solution (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03250923 — Phase 1 & 2
Oral Thrush Research Study Groups: silver citrate complex and acemannan
Oral Thrush Clinical Trial 2023: CelAgace™ OraRinse Solution Highlights & Side Effects. Trial Name: NCT03250923 — Phase 1 & 2
CelAgace™ OraRinse Solution (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03250923 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
CelAgace™ OraRinse Solution for Treatment of Candidiasis
2024. "CelAgace™ OraRinse Solution for Treatment of Candidiasis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03250923.
All > Yeast Infection
~10 spots leftby Sep 2024
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