Onychomycosis Clinical Trial
Verified date | June 2012 |
Source | Dow Pharmaceutical Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | Mexico: Ministry of Health |
Study type | Interventional |
The purpose of this study is to assess the safety and effectiveness of two concentrations of IDP-108 in treating patients with onychomycosis
Status | Completed |
Enrollment | 135 |
Est. completion date | April 2009 |
Est. primary completion date | April 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Presence of onychomycosis of the target toenail - A positive fungal culture from the target toenail Exclusion Criteria: - Any disease or condition that might cause nail abnormalities or may interfere with clinical evaluations - Presence of tinea pedis (athletes foot) - Female subjects who are pregnant, nursing, planning a pregnancy, or become pregnant during the study |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Mexico | Unidad de Investigación en Salud | Chihuahua | |
Mexico | Instituto Dermatólogico de Jalisco "Dr. Jose Barba Rubio" | Guadalajara | Jalisco |
Mexico | Clinical Research Institute | Mexico City | Federal District |
Mexico | Hospital Central Militar | Mexico City | Federal District |
Mexico | Hospital General de México | México City | Federal District |
Mexico | Centro de Dermatología de Monterrey | Monterrey | Nuevo León |
Mexico | Hospital Universitario "José E. González" | Monterrey | Nuevo León |
Mexico | MIRC/OCA Hospital | Monterrey | Nuevo León |
Mexico | Hospital Ignacio Morones Prieto SLP | San Luis Potosí | |
Mexico | Hospital Dr. Ángel Leaño | Zapopan | Jalisco |
Lead Sponsor | Collaborator |
---|---|
Dow Pharmaceutical Sciences |
Mexico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in area of infected nail | 9 months | No | |
Secondary | Change from baseline in mycological results | 9 months | No |
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 |
NCT01208168 -
Safety & 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 |
NCT01208129 -
Safety and 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 |
NCT00768768 -
Iontophoretic Application of Terbinafine Gel to the Large Toe Nail
|
Phase 1 | |
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 |