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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00777868
Enrollment
135
Registered
2008-10-22
Start date
2007-10-31
Completion date
2009-04-30
Last updated
2012-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Onychomycosis

Brief summary

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

Interventions

DRUGLow Strength IDP-108

Topical application once a day for 9 months

DRUGHigh Strength IDP-108

Topical application once a day for 9 months

DRUGHigh Strength IDP-108 under occlusion

Topical application once a day for 9 months

DRUGVehicle

Topical application once a day for 9 months

Sponsors

Dow Pharmaceutical Sciences
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Change from baseline in area of infected nail9 months

Secondary

MeasureTime frame
Change from baseline in mycological results9 months

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026