Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

n/a


Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00768768
Study type Interventional
Source Transport Pharmaceuticals
Contact
Status Completed
Phase Phase 1
Start date October 2008
Completion date March 2009

See also
  Status Clinical Trial Phase
Completed NCT03098615 - Study Evaluating the Effect of Jublia on Dermatophytomas Phase 4
Recruiting NCT01666002 - Treatment of Onychomycosis Using a 0.65 Millisecond Pulsed Nd:YAG 1064 nm Laser N/A
Terminated NCT01208129 - Safety and Efficacy of NAB001 in the Treatment of Mild to Moderate Onychomycosis of the Toenails Phase 3
Completed NCT01180491 - A Clinical Investigation on Early Visible Effects of Application of K101 During 8 Weeks on Discoloured and Deformed Nails Resulting From Onychomycosis N/A
Terminated NCT01208168 - Safety & Efficacy of NAB001 in the Treatment of Mild to Moderate Onychomycosis of the Toenails Phase 3
Completed NCT00385502 - A Trial of the Safety and Efficacy of EcoNailâ„¢ in the Treatment of Fungus Infections of the Great Toenail Phase 2
Completed NCT00253305 - Topical Gel Anti-Fungal Agent for Tinea Unguium Phase 2
Not yet recruiting NCT05809297 - Diode Laser and Photodynamic Therapy Vs. Ciclopirox. Phase 4
Completed NCT03405818 - An Evaluation of the Safety and Pharmacokinetics of Tavaborole Topical Solution for the Treatment of Fungal Disease of the Toenail in Children and Adolescents Phase 4
Completed NCT02588599 - A Retrospective Analysis of the Effects of Low Level Laser Therapy on Toenail Onychomycosis N/A
Recruiting NCT02436291 - Evaluation of the Efficacy of CURE-EX Treatment in Onychomycosis Phase 4
Completed NCT01851590 - Resin vs. Amorolfine vs. Terbinafine Treatment in Onychomycosis Phase 4
Completed NCT01452490 - Diode Laser Treatment of Onychomycosis N/A
Withdrawn NCT00938925 - Effectiveness of Podiatry Care on Onychomycosis (EPOCAON) N/A
Recruiting NCT00808366 - Efficacy and Safety of RV4104A Ointment in Onychomycosis N/A
Completed NCT00781820 - Comparative Efficacy of Bifonazole Cream vs Placebo After Nail Ablation With Urea Paste Phase 3
Completed NCT00777868 - A Dose-Ranging Study Evaluating the Safety and Efficacy of IDP-108 in Patients With Onychomycosis Phase 2
Recruiting NCT06074315 - Evaluation of the Effectiveness of Nail Genesis DLSO Product for Onychomycosis N/A
Completed NCT01039883 - A Study to Compare the Blood Levels of Albaconazole in Healthy Subjects Who Have Received a Single Dose of 400 mg Albaconazole as a Tablet Versus Albaconazole as a Capsule Phase 1
Suspended NCT05491603 - A Trial to Evaluate the Safety and Efficacy of DBI-001 Gel, DBI-002 Gel, and Aqueous Gel in Subjects With Onychomycosis Phase 2