OnychomycosisPhase 2NCT02355899
Evaluation of the Suitability of PD P 506 A in the PDT of Distal Subungual Onychomycosis (DSO) of the Great Toenail.
A Phase 2 study testing PD P 506 A in people with Onychomycosis, run by photonamic GmbH & Co. KG at 2 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Onychomycosis
- What is being tested?
- PD P 506 A
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesGermany
- Study dates
- Jan 2015to 23 Aug 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Klinik für Dermatologie, Klinikum Lippe
Detmold, 32756
Klinik für Dermatologie und Allergologie KLINIKUM VEST GMBH Knappschaftskrankenhaus Recklinghausen
Recklinghausen, 45657
About this study
Official title: Evaluation of the Suitability of PD P 506 A in the Photodynamic Therapy of Distal Subungual Onychomycosis (DSO) of the Great Toenail.
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.
- Conditions
- Onychomycosis
- Being tested
- PD P 506 A
- Medical subject headings
- Onychomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD P 506 ADrug
Also called Alacare®
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.
| Study group | Role | What they receive |
|---|---|---|
| PD P 506 A-PDT | Experimental | One PD P 506 A-patch will be administered to each great toenail for 4 hours. After removal of the study medication the study nail(s) s will be illuminated with red light of defined wavelength (PDT). Receives: Drug: PD P 506 A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of nails with Clinically Complete Cure
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".
Measured: 12 months after last study treatment
Secondary outcomes (7)
Percentage of nails with negative laboratory test results for onychomycosis (KOH test, periodic acid-Schiff (PAS) stain and mycology culture).
Measured: 12 months after last study treatment
Percentage of nails with Clinically Complete Cure
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".
Measured: 3 and 6 months after last study treatment
Frequency of adverse events
Measured: 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
The severity of AEs is defined as:
- Grade 1 = mild
- Grade 2 = moderate
- Grade 3 = severe
- Grade 4 = life-threatening
- Grade 5 = fatal
Measured: During the treatment phase on day 0, 7, 14 and 21, and 3, 6 and 12 months after last study treatment
Frequency of local reactions.
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.
Measured: During the treatment phase on day 0, 7, 14 and 21, and 3, 6 and 12 months after last study treatment
Severity (grade1-3) of local reactions.
The severity of local reactions is defined as:
- Grade 1 = mild
- Grade 2 = moderate
- Grade 3 = severe
Measured: During the treatment phase on day 0, 7, 14 and 21, and 3, 6 and 12 months after last study treatment
One photo of each treated toenail at the beginning of each visit
Documentation of the course of the study for each treated toenail.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2015 (estimated)
- Study startJan 2015
- Primary completion23 Aug 2017
- Study completion23 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OnychomycosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- photonamic GmbH & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rolf-Markus Szeimies, Prof. Dr., Principal investigator, KLINIKUM VEST GMBH Knappschaftskrankenhaus Recklinghausen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02355899
- Sponsor's protocol ID
- OM 01
- Status last verified
- Sep 2017
- First submitted
- 22 Jan 2015
- Last updated
- 19 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Suitability of PD P 506 A in the Photodynamic Therapy of Distal Subungual Onychomycosis (DSO) of the Great Toenail.
- ClinicalTrials.gov ID
- NCT02355899
- Acronym / sponsor ID
- OM 01
- Conditions
- Onychomycosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- photonamic GmbH & Co. KGIndustry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- 23 Aug 2017 (actual)
- Study completion
- 23 Aug 2017 (actual)
- First posted
- 4 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PD P 506 A-PDT | Experimental | Drug: PD P 506 AOne PD P 506 A-patch will be administered to each great toenail for 4 hours. After removal of the study medication the study nail(s) s will be illuminated with red light of defined wavelength (PDT). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PD P 506 AAlso: Alacare®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. | Drug | PD P 506 A-PDT |
Primary outcome
Percentage of nails with Clinically Complete Cure
Time frame: 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".
7 secondary outcomes
Percentage of nails with negative laboratory test results for onychomycosis (KOH test, periodic acid-Schiff (PAS) stain and mycology culture).
Time frame: 12 months after last study treatment
Percentage of nails with Clinically Complete Cure
Time frame: 3 and 6 months after last study treatment
Frequency of adverse events
Time frame: 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
Time frame: During the treatment phase on day 0, 7, 14 and 21, and 3, 6 and 12 months after last study treatment
Frequency of local reactions.
Time frame: During the treatment phase on day 0, 7, 14 and 21, and 3, 6 and 12 months after last study treatment
Severity (grade1-3) of local reactions.
Time frame: During the treatment phase on day 0, 7, 14 and 21, and 3, 6 and 12 months after last study treatment
One photo of each treated toenail at the beginning of each visit
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rolf-Markus Szeimies, Prof. Dr. principal investigator
KLINIKUM VEST GMBH Knappschaftskrankenhaus Recklinghausen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PD P 506 A in people with Onychomycosis, run by photonamic GmbH & Co. KG at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of nails with Clinically Complete Cure (time frame: 12 months after last study treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2017.