Patches for powered penetration
Results from Power Paper's safety and efficacy clinical trial demonstrate that the delivery of the proprietary formulation under electrical current is effective, safe and well tolerated. The trial was designed to compare the efficacy of a treatment with the formulation using a Power Paper iontophoretic onychomycosis treatment patch versus a passive treatment (without iontophoresis) with same formulation. Treatment was applied overnight, every day, five days per week, for four weeks, and patients were monitored for an additional 10 weeks.
Patients treated with twenty applications of the formulation with the active patch showed higher clinical improvement and a higher percentage of the nail plate was covered by healthy new nail. In addition, the drug content in nail samples taken from the patients treated with the active patch was several orders of magnitude higher than the published required minimum inhibitory concentration (MIC) for dermatophytes (the parasitic fungus thought to cause Onychomycosis). Furthermore, the amount of anti-fungal drug eluted from the patient's treated nails a month after treatment was over 350 times more than the amount observed after oral treatment with the same active drug.
By the end of treatment there was a significant increase in clear nail growth in the Power Paper patch group compared to the passive group. Furthermore, the percentage of patients with fungal elements in their nail specimens was significantly reduced for the group treated with the active patch, when compared with the passive group.
Follow-up visits, two and a half months after completing the treatment, further revealed that patients treated with the iontophoretic patch demonstrated a reservoir of the formulation in the nail bed.
Clinical laboratory results did not show any deleterious effects of the treatment and no adverse events were reported.
Power Paper's topical treatment of Onychomycosis has demonstrated a number of patient benefits, including:
- No systemic toxicity
- Fewer side effects
- Faster results
- Shorter treatment time
- Higher rate of efficiency
- Improved patient compliance
- Lower overall treatment costs
- Reduced relapse of fungal infection
The company is conducting Phase IIb clinical trials in 2008.