Trial document




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  DRKS00007618

Trial Description

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Title

Evaluation of the suitability of PD P 506 A in the photodynamic therapy of Distal Subungual Onychomycosis (DSO) of the great toenail.

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Trial Acronym

OM 01

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URL of the Trial

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Brief Summary in Lay Language

Onychomycosis is a chronic fungal infection of the finger- or toenails and one of the commonest dermatological conditions.Current onychomycosis treatment has to be performed over a long period, needs a high patient compliance and can be costly. In literature, case reports of successful photodynamic therapy of onychomycoses or reports of uncontrolled studies can be found. In these publications, photodynamic therapy of onychomycosis seems to achieve at least the same efficacy as established therapies in a much shorter time period. In order to facilitate photodynamic therapy and to shorten handling times, a self-adhesive, skin coloured thin 5-ALA-containing plaster (product code PD P 506 A, brand name: Alacare®) was developed and approved in 2009 for the treatment of actinic keratoses. PD P 506 A has also the potential to facilitate photodynamic therapy of onychomycosis and make it a viable, effective alternative for the patient. This explorative pilot study aims therefore to assess the safety and tolerability of a fourfold photodynamic therapy with 5-ALA in the treatment of onychomycosis. Prior to PDT, the patient will soften the nail to be treated for 24-30 hours with a 40% urea ointment unter an occlusive dressing. After cleaning the toenail from residual ointment, the investigator will apply the PD P 506 A patch on it. The application duration of PD P 506 A and the subsequent illumination will take place with the same condicions that have been tested and proven safe for Alacare®. Photodynamic therapy will be repeated four times in a weekly interval.

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Brief Summary in Scientific Language

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.
Current OM treatment has to be performed over a long period, needs a high patient compliance and can be costly. For fingernails, the treatment period is around 3-6 months, for toenails it could be more than 12 months. In order to achieve a cure which is as long-lasting as possible, a combination therapy is frequently chosen which consists of topical and systemic antimycotics as well as the atraumatic removal of the nail .
However, because of the long treatment periods, comparatively low cure rates between 25 - 50 % and high recurrence rates of up to 53 %, the treatment of OM still proves to be extremely difficult.
In literature, case reports of successful PDT treatment of onychomycoses or reports of uncontrolled studies can be found. In thgese publications, PDT of onychomycosis seems to achieve at least the same efficacy as established therapies in a much shorter time period.
In order to facilitate PDT and to shorten handling times, a self-adhesive, skin coloured thin 5-aminolevulinic acid hydrochloride-containing plaster (product code PD P 506 A, brand name: Alacare®) was developed and approved for the treatment of actinic keratoses. PD P 506 A has also the potential to facilitate Onychomycosis-PDT and make it a viable, effective alternative for the patient. This explorative pilot study aims therefore to assess the safety and tolerability of a fourfold photodynamic therapy with 5-ALA in the treatment of onychomycosis. Prior to PDT, the patient will soften the nail to be treated for 24-30 hours with a 40% urea ointment unter an occlusive dressing. After cleaning the toenail from residual ointment, the investigator will apply the PD P 506 A patch on it. The application duration of PD P 506 A and the subsequent illumination will take place with the same parameters that have been tested and proven safe for Alacare®. Photodynamic therapy will be repeated four times in a weekly interval.

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Organizational Data

  •   DRKS00007618
  •   2014/12/17
  •   2014/10/14
  •   no
  •   Approved
  •   2014-543-f-A, Ethik-Kommission der Ärztekammer Westfalen-Lippe und der med. Fakultät der Westfälischen Wilhelms-Universität Münster
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Secondary IDs

  •   2014-001493-34 
  •   EUCTR2014-001493-34-DE  (EUCTR)
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Health Condition or Problem studied

  •   B35.1 -  Tinea unguium
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Interventions/Observational Groups

  •   Application of PD P 506 A (active substance: 8 mg 5-aminolevulinic acid/patch) on the diseased nail for 4 h and subsequent illumination with red light (37 J/cm²). 4 treatments in weekly intervalls.
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   II
  •   Yes
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Primary Outcome

Evaluation of the clinical efficacy of PD P 506 A photodynamic therapy of distal subungual onychomycosis of the great toenail(s) on nail basis according to Scher et al. [Onychomycosis: diagnosis and definition of cure. J Am Acad Dermatol. 2007 Jun;56(6):939-44] 12 months after last photodynamic therapy.

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Secondary Outcome

• Evaluation of the efficacy of PD P 506 A photodynamic therapy of distal subungual onychomycosis of the great toenail(s) on nail basis 12 months after treating participants as measured by laboratory methods.

• Evaluation of the clinical efficacy of PD P 506 A photodynamic therapy of distal subungual onychomycosis of the great toenail(s) on nail basis according to Scher et al. 3 and 6 months after treating participants.

• Evaluation of safety and tolerability of PD P 506 A photodynamic therapy of distal subungual onychomycosis of the great toenail(s).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2015/02/04
  •   22
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   75   Years
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Additional 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

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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

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Addresses

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    • photonamic GmbH & Co. KG
    • Theaterstraße 6
    • 22880  Wedel
    • Germany
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    • Klinik für Dermatologie und AllergologieKLINIKUM VEST GMBHKnappschaftskrankenhaus Recklinghausen
    • Mr.  Prof. Dr. med.  Rolf-Markus  Szeimies 
    • Dorstener Str. 151
    • 45657  Recklinghausen
    • Germany
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    • photonamic GmbH & Co. KG
    • Mr.  Dr.  Marcus  Stocker 
    • Theaterstraße 6
    • 22880  Wedel
    • Germany
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Sources of Monetary or Material Support

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    • photonamic GmbH & Co. KG
    • Theaterstraße 6
    • 22880  Wedel
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2017/08/23
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Trial Publications, Results and other Documents

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