Onychomycosis Clinical Trial
Official title:
A Randomized, Double Blind, Multiple-site, Placebo-Controlled Study, Comparing the Efficacy and Safety of SUBA™-Itraconazole Capsules Compared to SPORANOX® (Itraconazole) Capsules in the Treatment of Onychomycosis of the Toenail
The objective of this study is to compare the relative efficacy and safety of SUBA™-Itraconazole Capsules (HalcyGen Ltd) to an already marketed oral formulation of itraconazole SPORANOX® (itraconazole) capsules (Janssen Pharma) in the treatment of onychomycosis of the toenail. Both the test and the reference formulations will also be compared to a placebo formulation to test for superiority.
Randomized, Double-Blind, Multiple-Site, Placebo-Controlled, Parallel designed study comparing a dosing regimen of 100 mg approximately 30 minutes prior to breakfast for 12 weeks of SUBA™-Itraconazole 50 mg capsules (HalcyGen Ltd) to the approved dosing regimen of 200 mg taken with breakfast of SPORANOX® (itraconazole) 100 mg capsules (Janssen Pharma). Patients will be randomly assigned in a 3:3:1 ratio to the test product 100 mg once-a-day: reference product 200 mg once-a-day: placebo once-a-day. respectively. The patients will complete 5 visits: baseline/screening (within 28 days of randomization), Day 1 (randomization), Week 6, Week 12 and Week 24. ;
| 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 | |
| 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 |
NCT01208129 -
Safety and Efficacy of NAB001 in the Treatment of Mild to Moderate Onychomycosis of the Toenails
|
Phase 3 | |
| 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 EcoNail™ 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 |
NCT00768768 -
Iontophoretic Application of Terbinafine Gel to the Large Toe Nail
|
Phase 1 | |
| 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 |