A Dose-Ranging Study Evaluating the Safety and Efficacy of IDP-108 in Patients With Onychomycosis

Dow Pharmaceutical Sciences135 enrolled

Overview

The purpose of this study is to assess the safety and effectiveness of two concentrations of IDP-108 in treating patients with onychomycosis

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

135

Conditions

Onychomycosis

Interventions

Low Strength IDP-108DRUG

Topical application once a day for 9 months

High Strength IDP-108DRUG

Topical application once a day for 9 months

High Strength IDP-108 under occlusionDRUG

Topical application once a day for 9 months

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (10)

Unidad de Investigación en Salud

Chihuahua City, Chihuahua, Mexico

Clinical Research Institute

Mexico City, Federal District, Mexico

Hospital Central Militar

Mexico City, Federal District, Mexico

Outcomes

Primary Outcomes

Change from baseline in area of infected nail

Time frame: 9 months

Secondary Outcomes

Change from baseline in mycological results

Time frame: 9 months

Data from ClinicalTrials.gov

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