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NCT Number: NCT02355899

Evaluation of the Suitability of PD P 506 A in the PDT 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.

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Key information

Conditions

Onychomycosis Bacterial Infections and Mycoses Dermatomycoses Infections Mycoses Nail Diseases Skin Diseases Skin Diseases, Infectious Skin and Connective Tissue Diseases Tinea

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Klinik für Dermatologie, Klinikum Lippe, Detmold, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PD P 506 A

Drug

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.

Other names: Alacare®

Primary outcomes

  1. 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".

Secondary outcomes

  1. 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

  2. Percentage of nails with Clinically Complete Cure

    Time frame: 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".

  3. 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

  4. 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

    The severity of AEs is defined as:

    • Grade 1 = mild
    • Grade 2 = moderate
    • Grade 3 = severe
    • Grade 4 = life-threatening
    • Grade 5 = fatal

  5. 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

    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.

  6. 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

    The severity of local reactions is defined as:

    • Grade 1 = mild
    • Grade 2 = moderate
    • Grade 3 = severe

  7. 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.

    Documentation of the course of the study for each treated toenail.

Sponsors and collaborators

Lead sponsor

photonamic GmbH & Co. KG

Industry

Registry information

Official study title

Evaluation of the Suitability of PD P 506 A in the Photodynamic Therapy of Distal Subungual Onychomycosis (DSO) of the Great Toenail.

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Feb 4, 2015
Registry last updated
Sep 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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