Chlorhexidine and nystatin in the treatment of oral candidosis - a pilot study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-005027-81-FI

Enrollment

Registered

2018-08-14

Start date

2018-08-14

Completion date

Unknown

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

oral candidosis

Interventions

Trade Name: Mykundex Product Name: Mykundex Pharmaceutical Form: Suspension for oral suspension INN or Proposed INN: NYSTATIN CAS Number: 400-61-9 Concentration unit: IU/ml international unit(s)/milli

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Oral candidosis diagnosed with oral swab Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: Age under 18, pregnancy or planning pregnancy, allergy to chlorhexidine, nystatin or additional ingredients of the study products, hereditary fructose-intolerance, fructose-intolerance, glucose-galactose absorption disorder, or saccarose-isomaltase deficiency, oral mucosal disease such as lichen planus or mucous membrane pemphigoid with severe symptoms, immunosuppressive condition such as untreated HIV-infection, on-going treatment for cancer, systemic immunosuppressive medication, desinfectant oral rinse or yeast infection medication used during the last four weeks.

Design outcomes

Primary

Measure	Time frame
Main Objective: To examine the use of chlorhexidine in the treatment of oral candidosis;Secondary Objective: To study the different diagnostic methods of oral candidosis and to study the salivary metabolites in oral candidosis;Primary end point(s): not/applicaple;Timepoint(s) of evaluation of this end point: not/applicaple	—

Secondary

Measure	Time frame
Secondary end point(s): not/applicaple;Timepoint(s) of evaluation of this end point: not/applicaple	—

Countries

Finland

Contacts

Public ContactClinical Trials Information

Maria Siponen

maria.siponen@uef.fi

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026