Light treatment of superficial fungal infection (ringworm) which is not responding to conventional antifungal medication

Photodynamic therapy of antifungal resistant dermatophytes - PDT for resistant dermatophytosis

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-002644-23-DK

Enrollment

Registered

2020-06-15

Start date

2020-07-23

Completion date

Unknown

Last updated

2024-08-26

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

Conditions

Competent patients over 18 years old with mycological verified antifungal resistant dermatophytosis MedDRA version: 20.1 Level: HLT Classification code 10043870 Term: Tinea infections System Organ Class: 10021881 - Infections and infestations MedDRA version: 20.0 Level: PT Classification code 10043868 Term: Tinea cruris System Organ Class: 10021881 - Infections and infestations MedDRA version: 20.0 Level: PT Classification code 10060889 Term: Tinea infection System Organ Class: 10021881 - Inf

Interventions

Trade Name: Methylthioniniumchlorid Proveblue Product Name: Methylene blue Pharmaceutical Form: Concentrate and solvent for solution for injection/infusion INN or Proposed INN: Methylthioninium chlori

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Written informed consent has been obtained prior to initiating any study specific procedures • Legally competent men and women of at least 18 years old • Subjects confirmed antifungal resistance and dermatophytosis • Women of child bearing potential should be willing to use contraception 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 5

Exclusion criteria

Exclusion criteria: • Subjects who have previously participated in this study • Pregnant or lactating patients will likewise not be included • Subjects who are allergic to colour or light. • Antifungal use 14 days before inclusion • Patients receiving concomitant medication associated with known phototoxicity e.g.tetracyklines, thiazide, SSRI, kinin, lariam or natualmedication with St. John's Wort

Design outcomes

Primary

Measure	Time frame
Main Objective: An exploration of non-pharmaceutical therapeutic options for the treatment of fungal infection with a predictable low adverse effect profile. We aim to investigate resistant fungal skin infections;Secondary Objective: Primary endpoint. Clinical clearance. Secondary endpoint mycological clearance;Primary end point(s): Clinical clearance of infection;Timepoint(s) of evaluation of this end point: 1 month follow-up	—

Measure

Time frame

Main Objective: An exploration of non-pharmaceutical therapeutic options for the treatment of fungal infection with a predictable low adverse effect profile. We aim to investigate resistant fungal skin infections;Secondary Objective: Primary endpoint. Clinical clearance. Secondary endpoint mycological clearance;Primary end point(s): Clinical clearance of infection;Timepoint(s) of evaluation of this end point: 1 month follow-up

—

Secondary

Measure	Time frame
Secondary end point(s): Mycological clearance of the infection;Timepoint(s) of evaluation of this end point: 1 month follow-up	—

Countries

Denmark

Contacts

Public ContactDitte Marie Saunte

Dept. of Dermatology, Zealand University Hospital, Roskilde

disa@regionsjaelland.dk004547322651

Outcome results

None listed

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