Onychomycosis (OM) is a chronic fungal infection of the finger- or toenails and one of the commonest dermatological conditions. It accounts for one third of fungal skin infections and constitutes about a half of all nail abnormalities. In most cases, OM is caused by dermatophytes, mostly Trichophyton rubrum (84-90%). Yeasts (e.g. Candida parapsilosis
Conditions
Interventions
Trade Name: Alacare 8 mg medicated plaster
Pharmaceutical Form: Medicated plaster
INN or Proposed INN: 5-aminolevulinic acid hydrochloride
CAS Number: 5451-09-2
Other descriptive name: AMINOLEVULINIC
Sponsors
photonamic GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male patients, 18 - 75 years of age • Females up to an age of 75 years, provided that they are postmenopausal, i.e. with spontaneous amenorrhea for at least 12 months or not of childbearing potential because of tubal ligation or hysterectomy • DSO of at least one of the great toe(s) affecting 20% to 60% of the target nail without spikes will be confirmed by at least one of the three methods: the methods of KOH test, periodic acid-Schiff (PAS) stain and mycology culture • The toenail infection can be due to a dermatophyte, yeast or mixed infections (dermatophyte and non-dermatophyte) • Toenails have to be cut regularly (indicator for existing growth) • Signed written informed consent 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 11 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 11
Exclusion criteria
Exclusion criteria: • Patients with the target toenail involving the matrix (lunula) or having less than 2 mm clear (unaffected) nail plate length beyond the proximal fold • Presence of dermatophytoma (defined as demarcated and localised thick masses (= 3 mm) of fungal hyphae and necrotic keratin between the nail plate and nail bed) on the target nail • Other conditions than DSO known to cause abnormal nail appearance • Topical antifungal treatment of the nails within 1 month before PDT • Systemic use of antifungal treatment within 3 months before PDT • Patients who are unwilling to provide nail clippings • Patients who have been previously reported to be allergic against 5-aminolevulinic acid or other ingredients of PD P 506 A • Diagnosis of porphyria • Diagnosis of polyneuropathy • Dementia or psychic condition that might interfere with the ability to understand the study and thus give written informed consent • Simultaneous participation in another clinical study or participation in another clinical study in the 30 days directly preceding treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of the clinical efficacy of PD P 506 A photodynamic therapy of DSO of the great toenail(s) on nail basis 12 months after treating participants. ;Secondary Objective: • Evaluation of the efficacy of PD P 506 A photodynamic therapy of DSO of the great toenail(s) on nail basis 12 months after treating participants as measured by laboratory methods. • Evaluation of the efficacy of PD P 506 A photodynamic therapy of DSO of the great toenail(s) on nail basis 3 and 6 months after treating participants. • Evaluation of safety and tolerability of PD P 506 A photodynamic therapy of DSO of the great toenail(s). ;Primary end point(s): Percentage of nails with Clinically Complete Cure (CCR; clinically complete clear nail).;Timepoint(s) of evaluation of this end point: 12 months after the last study treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Photo documentation. • Percentage of nails with negative result after 12 months using laboratory methods (KOH test, periodic acid-Schiff (PAS) stain and mycology culture). • Percentage of nails with CCR after 3 and 6 months of treatment. • Frequency and severity of adverse events and local tolerability signs/symptoms. ;Timepoint(s) of evaluation of this end point: 3, 6 and 12 months of treatment (see above). | — |
Countries
Germany
Contacts
Public ContactProject Management
photonamic GmbH & Co. KG
Outcome results
None listed