Onychomycosis
Conditions
Brief summary
This study evaluates the potential usefulness of photodynamic therapy with PD P 506 A in patients with distal subungual onychomycosis of the great toenail. Patients will receive four PDT treatments with PD P 506 A in weekly intervals.
Interventions
DRUGPD P 506 A
PD P 506 A is a dermal patch of 4 cm² in size loaded with 2 mg 5-ALA (as 5-ALA HCl) per cm².
Sponsors
photonamic GmbH & Co. KG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Male 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, confirmed before Visit 1 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
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 | Description |
|---|---|---|
| Percentage of nails with Clinically Complete Cure | 12 months after last study treatment | The Complete Clinical Clearance of each treated nail will be determined 3, 6 and 12 months after last study treatment. Based on a visual inspection, the nail(s) will either be defined as completely cleared or partially or not cleared. To be defined as completely cleared, a nail must show 100% absence of the 4 following clinical signs of onychomycosis (according to Scher et al., J Am Acad Dermatol. 2007 Jun;56(6):939-44): * Residual changes of the nail plate compatible with dermatophyte infection * White/yellow or orange brown/patches or streaks in or beneath the nail * Lateral onycholysis with debris in an otherwise clear nail plate * Hyperkeratoses on the lateral nail plate/nailfold edge. If the nail shows an improvement but still one of the above signs, it will be rated as partially cleared. If the nail shows no improvement in comparison to the Screening Visit, it will be rated as not cleared. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of nails with Clinically Complete Cure | 3 and 6 months after last study treatment | The Complete Clinical Clearance of each treated nail will be determined 3, 6 and 12 months after last study treatment. Based on a visual inspection, the nail(s) will either be defined as completely cleared or partially or not cleared. To be defined as completely cleared, a nail must show 100% absence of the 4 following clinical signs of onychomycosis (according to Scher et al., J Am Acad Dermatol. 2007 Jun;56(6):939-44): * Residual changes of the nail plate compatible with dermatophyte infection * White/yellow or orange brown/patches or streaks in or beneath the nail * Lateral onycholysis with debris in an otherwise clear nail plate * Hyperkeratoses on the lateral nail plate/nailfold edge. If the nail shows an improvement but still one of the above signs, it will be rated as partially cleared. If the nail shows no improvement in comparison to the Screening Visit, it will be rated as not cleared. |
| Frequency of adverse events | During the treatment phase on day 0, 7, 14 and 21, and 3, 6 and 12 months after last study treatment | — |
| Severity (grade1-5) of adverse events | During the treatment phase on day 0, 7, 14 and 21, and 3, 6 and 12 months after last study treatment | The severity of AEs is defined as: * Grade 1 = mild * Grade 2 = moderate * Grade 3 = severe * Grade 4 = life-threatening * Grade 5 = fatal |
| Percentage of nails with negative laboratory test results for onychomycosis (KOH test, periodic acid-Schiff (PAS) stain and mycology culture). | 12 months after last study treatment | — |
| Severity (grade1-3) of local reactions. | During the treatment phase on day 0, 7, 14 and 21, and 3, 6 and 12 months after last study treatment | The severity of local reactions is defined as: * Grade 1 = mild * Grade 2 = moderate * Grade 3 = severe |
| One photo of each treated toenail at the beginning of each visit | At screening visit (up to 4 weeks before first treatment), during the treatment phase on day 0, 7, 14 and 21, and 3, 6 and 12 months after last study treatment. | Documentation of the course of the study for each treated toenail. |
| Frequency of local reactions. | During the treatment phase on day 0, 7, 14 and 21, and 3, 6 and 12 months after last study treatment | Photodynamic therapy is intended to produce a phototoxic reaction, which is part of the desired effect. After PDT, treated toes may show local reactions such as redness and swelling. |
Countries
Germany
Outcome results
None listed