Study of Antimicrobial Efficacy of PDT and SDT in Human Volunteers

Pilot Study of Combined PDT and SDT Efficacy In Vivo in Human Volunteers for Application in Hygiene and Clinical Practice

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2023-000126-29-CZ

Enrollment

Registered

2023-01-31

Start date

2023-04-21

Completion date

Unknown

Last updated

2024-11-11

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

Conditions

Antimicrobial efficacy of combined PDT and SDT on the skin

Interventions

Trade Name: Methylthioniniumchlorid Proveblue Product Name: Methylthioniniumchlorid Proveblue Pharmaceutical Form: Solution for injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Healthy volunteers 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 16 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2

Exclusion criteria

Exclusion criteria: Persons not meeting the inclusion criteria

Design outcomes

Primary

Measure	Time frame
Main Objective: Validation of the antimicrobial effect of the methylene blue and selection of the most effective testing strategy in conjunction with PDT and SDT.;Secondary Objective: Not applicable;Primary end point(s): Termination of application of the substance with PDT and SDT;Timepoint(s) of evaluation of this end point: Discontinuation of application	—

Secondary

Measure	Time frame
Secondary end point(s): Not applicable for design of this study;Timepoint(s) of evaluation of this end point: Not applicable for design of this study	—

Countries

Czech Republic

Contacts

Public ContactDagmar Jírová

Státní zdravotní ústav

dagmar.jirova@szu.cz420267082522

Outcome results

None listed

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