ight treatment of superficial fungal infection (ringworm) which is not responding to conventional antifungal medicatio

Phase 1

Conditions: Competent patients over 18 years old with mycological verified antifungal resistant dermatophytosis
MedDRA version: 20.1Level: HLTClassification code 10043870Term: Tinea infectionsSystem Organ Class: 10021881 - Infections and infestations
MedDRA version: 20.0Level: PTClassification code 10043868Term: Tinea crurisSystem Organ Class: 10021881 - Infections and infestations
MedDRA version: 20.0Level: PTClassification code 10060889Term: Tinea infectionSystem Organ Class: 10021881 - Infections and infestations
MedDRA version: 21.1Level: PTClassification code 10043873Term: Tinea pedisSystem Organ Class: 10021881 - Infections and infestations
MedDRA version: 20.0Level: PTClassification code 10049591Term: Tinea imbricataSystem Organ Class: 10021881 - Infections and infestations
MedDRA version: 20.0Level: PTClassification code 10067197Term: Tinea manuumSystem Organ Class: 10021881 - Infections and infestations
MedDRA version: 20.0Level: LLTClassification code 10043872Term: Tinea NOSSystem Organ Class: 10021881 - Infections and infestations
MedDRA version: 20.1Level: LLTClassification code 10043869Term: Tinea infection NOSSystem Organ Class: 10021881 - Infections and infestations
MedDRA version: 20.0Level: LLTClassification code 10043867Term: Tinea corporisSystem Organ Class: 10021881 - Infections and infestations

Registration Number: EUCTR2020-002644-23-DK

Lead Sponsor: Dept. of Dermatology, Zealand University Hospital, Roskilde

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 25

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

•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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures