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Terbinafine is recognized as one of the most effective drugs for the treatment of toe nail fungus (onychomycosis). This trial will be the first test of a new device to improve the delivery of terbinafine directly to the toe nail. The device uses a low level of electric current, iontophoresis, to "push" the terbinafine into the nail.
The study will involve a single application of terbinafine, in a gel form, with the iontophoretic device. The treatment will be applied to the surface of both large toenails of healthy subjects. Subjects will be asked to report any sensations in the nail or surrounding skin experienced during or after treatment. Samples from the edge of the treated toe nail will be taken at 2-4 week intervals to measure how much terbinafine was delivered to the nails, and blood samples will be taken for the first 24 hours after treatment to determine how much, if any, terbinafine was absorbed into the subjects's body. Observations will also be made of the treated toes to look for any irritation of the surrounding skin due to the treatment.
Re: Iontophoretic application of terbinafine to toenails
Wondering if they will have a control group / condition, with the gel applied without iontopheresis ? Otherwise the data cannot demonstrate the penetration levels of the drug due to the modality …
The findings may also have greater external validity if subjects had dystrophic nails, rather than healthy….. and if clinical outcomes were used in addition to tissue concentration levels ?
Re: Iontophoretic application of terbinafine to toenails
As they are using normal people and not assessing clinical outcomes, its just a Phase 2 study on the use of terbinafine this way ... begs the question as to why they bothered to register it ???
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Trans-nail permeability is limited due to the innate nature of the nail plate and the recent investigations indicated the potential of iontophoresis in enhancing the transungual drug delivery in normal nails. However, the onychomycotic nails differ from the normal nails with respect to the anatomical and biological features. The current study investigated the effect of iontophoresis (0.5 mA/cm(2) for 1 h) on the transungual delivery of terbinafine in onychomycotic finger and toe nails. The presence of fungi in the onychomycotic nails was diagnosed by potassium hydroxide (KOH) microscopy. Passive and iontophoretic delivery of terbinafine across the infected nail was studied in Franz diffusion cell. Further, the release profile of terbinafine from the drug-loaded nails was investigated by agar diffusion method. KOH microscopy confirmed the presence of fungi in all the nails used. The amount of drug permeated across the nail plate was enhanced significantly during iontophoresis over passive delivery, that is, by 21-fold in case of finger and 37-fold in case of toe nails. Further, the total drug load in the onychomycotic nail was enhanced by ~12-fold (in both finger and toe nails) due to iontophoresis. Release of terbinafine from the iontophoresis-loaded nails into agar plates exhibited two phases, a rapid phase followed by a steady release, which extended >2 months. This study concluded that the drug delivery in onychomycotic nails did not differ significantly when compared with normal nails, although the extent of drug permeation and drug load differs between finger and toe nails.
Iontophoretic application of terbinafine to toenails
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