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

Dova Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Onychomycosis

Treatments: Drug: High Strength IDP-108; Drug: Vehicle; Drug: High Strength IDP-108 under occlusion; Drug: Low Strength IDP-108

Study type: Interventional

Funder types: Industry

Identifiers

NCT00777868

DPSI-IDP-108-P2-01

Details and patient eligibility

About

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

Enrollment: 135 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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135 participants in 4 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: Low Strength IDP-108

2

Experimental group

Treatment:

Drug: High Strength IDP-108

3

Experimental group

Treatment:

Drug: High Strength IDP-108 under occlusion

4

Placebo Comparator group

Treatment:

Drug: Vehicle