Therapeutic clinical trial of three types of “Phlogosol concentrate for gargle” products, comparing their efficacy in reducing different inflammations of the oral cavity

Therapeutic clinical trial of three types of “Phlogosol concentrate for gargle” products, comparing their efficacy in reducing different inflammations of the oral cavity. (Changing the active ingredient of “Phlogosol concentrate for gargle” of oral cavity from hexachlorophene to chlorhexidine, the two products with different active ingredients in a non-inferiority clinical trial in comparison to the third control product.)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-002190-22-HU

Enrollment

Registered

2014-01-07

Start date

2014-03-26

Completion date

Unknown

Last updated

2022-04-04

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

Conditions

Cold with sore throat, acute stomatitis, chronic pharyngitis acute tonsillitis, acute laryngitis, herpes stomatitis, superficial glossitis, acute and chronic gingivitis, ulcerative gingivitis, parodontitis, before or after tooth extraction, oral surgery, aphta recidivans

Interventions

Product Name: Phlogosol Duo 30 mg/2 mg/ml koncentrátum toroköblítohöz Pharmaceutical Form: Concentrate for gargle INN or Proposed INN: chlorhexidine gluconate CAS Number: 18472-51-0 Other descriptive

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion Criteria -18 years or older male or female -local inflammatory changes in the oral cavity -The indications of the approved SPC of Phlogosol solution, especially the dental indications. - Cold with sore throat, acute stomatitis, chronic pharyngitis acute tonsillitis, acute laryngitis, herpetic stomatitis, superficial glossitis, acute and chronic gingivitis, ulcerative gingivitis, parodontitis, before or after tooth extraction, oral surgery, aphta recidivans, The patient signed the Inform Consent Form and the PIL 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 54 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 21

Exclusion criteria

Exclusion criteria: Contraindications: Contraindications as listed in the SPC manual, as well as: Sensitivity to the active ingredients of the product, or to other ingredients in the sample products. May only be used 10-12 days after tonsillectomy, as early removal of the fibrin layer covering the fresh wound could cause delayed bleeding. Can not be used for treating eyes, vaginal mucosa, injured skin, or in other skin diseases. Exclusion Criteria: In this clinical trial the samples are not to be used in the following cases: -Tumour of the oral cavity, -Surgery, radiation and/or chemotherapy, or other anti-tumour treatment within 4 weeks of planned study enrolment -Active infection requiring systemic antibiotic or antimycotic therapy -Immune deficiency -Acute allergy (caused by medication, food, metal etc.) that causes acute or chronic stomatitis -Participation in any other clinical trial within 1 month time. -Pregnancy or lactation -The patient doesn’t understand the questions or doesn’t want to participate in this clinical trial

Design outcomes

Primary

Measure	Time frame
Main Objective: Cure or improve healing of inflammations of the oral cavity mucosa;Secondary Objective: Reduction of different inflammations of the oral cavity mucosa;Primary end point(s): Phlogosol Duo is not inferior to Phlogosol Solution for external use only;Timepoint(s) of evaluation of this end point: 1 week	—

Secondary

Measure	Time frame
Secondary end point(s): Phlogosol Uno is not inferior to Plogosol Duo and Phlogosol Solution for external use only, in comparison these three products;Timepoint(s) of evaluation of this end point: 1 week	—

Countries

Hungary

Contacts

Public ContactMedical director

PannonPharma Ltd.

info@pannonpharma.hu+3626340594

Outcome results

None listed

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