CelAgace™ OraRinse Solution for Treatment of Candidiasis

NCT03250923 | Unknown Phase 1 FDA Drug

• 1 other identifier: IRB2017-0042
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Candidiasis, Oral

Keywords

Oral Candidiasis, Thrush, Oral Moniliasis

Outcome Measures

Primary Outcomes (1)

• 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.

  Days 1(Baseline), 3, 7 and 14

Secondary Outcomes (1)

• Reduction in Pain

  Days 1, 3, 7, 14

Study Arms (1)

silver citrate complex and acemannan

EXPERIMENTAL

This is a single arm open pilot trial. All participants will receive study drug.

Drug: silver citrate complex and acemannan

Interventions

silver citrate complex and acemannan DRUG

Oral rinse solution with each dose containing 100μg silver citrate complex and 40mg acemannan

Also known as: CelAgace™ OraRinse Solution

silver citrate complex and acemannan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• CelaCare Technologies, Inc.: lead
• Texas A&M University: collaborator

Study Sites (1)

Texas A&M University College of Dentistry

Dallas, Texas, 75246, United States

Location

MeSH Terms

Conditions

Candidiasis, Oral

Interventions

acemannan

Condition Hierarchy (Ancestors)

Candidiasis; Mycoses; Bacterial Infections and Mycoses; Infections; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Jacqueline M. Plemons, DDS, MS

  Texas A&M University College of Dentistry

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacqueline M. Plemons, DDS, MS

CONTACT

214-828-8467; jplemons@tamhsc.edu

Celeste M. Abraham, DDS, MS

CONTACT

214-828-8467; cabraham@tamhsc.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2017
• First Posted: August 16, 2017
• Study Start: September 1, 2024
• Primary Completion: September 1, 2024
• Study Completion: May 1, 2025
• Last Updated: February 9, 2024

Record last verified: 2023-02

Locations

US (1)