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

June 20, 2012 updated by: Dow Pharmaceutical Sciences
The purpose of this study is to assess the safety and effectiveness of two concentrations of IDP-108 in treating patients with onychomycosis

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

135

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Chihuahua, Mexico, CP31205
        • Unidad de Investigación en Salud
      • San Luis Potosí, Mexico, CP 78240
        • Hospital Ignacio Morones Prieto SLP
    • Federal District
      • Mexico City, Federal District, Mexico, CP54055
        • Clinical Research Institute
      • Mexico City, Federal District, Mexico
        • Hospital Central Militar
      • México City, Federal District, Mexico, CP 06726
        • Hospital General de Mexico
    • Jalisco
      • Guadalajara, Jalisco, Mexico, CP45190
        • Instituto Dermatólogico de Jalisco "Dr. Jose Barba Rubio"
      • Zapopan, Jalisco, Mexico, CP45200
        • Hospital Dr. Ángel Leaño
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, CP64000
        • MIRC/OCA Hospital
      • Monterrey, Nuevo León, Mexico, CP64460
        • Centro de Dermatologia de Monterrey
      • Monterrey, Nuevo León, Mexico, CP64460
        • Hospital Universitario "José E. González"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: Low Strength IDP-108
Topical application once a day for 9 months
Experimental: 2
Drug: High Strength IDP-108
Topical application once a day for 9 months
Experimental: 3
Drug: High Strength IDP-108 under occlusion
Topical application once a day for 9 months
Placebo Comparator: 4
Drug: Vehicle
Topical application once a day for 9 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in area of infected nail
Time Frame: 9 months
9 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in mycological results
Time Frame: 9 months
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dow Pharmaceutical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

October 20, 2008

First Submitted That Met QC Criteria

October 20, 2008

First Posted (Estimate)

October 22, 2008

Study Record Updates

Last Update Posted (Estimate)

June 22, 2012

Last Update Submitted That Met QC Criteria

June 20, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DPSI-IDP-108-P2-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Onychomycosis

Clinical Trials on Low Strength IDP-108

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tanzania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe