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

Primary Purpose

Onychomycosis

Status
Completed
Phase
Phase 2
Locations
Mexico
Study Type
Interventional
Intervention
Low Strength IDP-108
High Strength IDP-108
High Strength IDP-108 under occlusion
Vehicle
Sponsored by
Dow Pharmaceutical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Onychomycosis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Clinical Research Institute
  • Hospital Central Militar
  • Hospital General de México
  • Instituto Dermatólogico de Jalisco "Dr. Jose Barba Rubio"
  • Hospital Dr. Ángel Leaño
  • MIRC/OCA Hospital
  • Centro de Dermatología de Monterrey
  • Hospital Universitario "José E. González"
  • Unidad de Investigación en Salud
  • Hospital Ignacio Morones Prieto SLP

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

1

2

3

4

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline in area of infected nail

Secondary Outcome Measures

Change from baseline in mycological results

Full Information

First Posted
October 20, 2008
Last Updated
June 20, 2012
Sponsor
Dow Pharmaceutical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00777868
Brief Title
A Dose-Ranging Study Evaluating the Safety and Efficacy of IDP-108 in Patients With Onychomycosis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dow Pharmaceutical Sciences

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Onychomycosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
135 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Experimental
Arm Title
4
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Low Strength IDP-108
Intervention Description
Topical application once a day for 9 months
Intervention Type
Drug
Intervention Name(s)
High Strength IDP-108
Intervention Description
Topical application once a day for 9 months
Intervention Type
Drug
Intervention Name(s)
High Strength IDP-108 under occlusion
Intervention Description
Topical application once a day for 9 months
Intervention Type
Drug
Intervention Name(s)
Vehicle
Intervention Description
Topical application once a day for 9 months
Primary Outcome Measure Information:
Title
Change from baseline in area of infected nail
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Change from baseline in mycological results
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Clinical Research Institute
City
Mexico City
State/Province
Federal District
ZIP/Postal Code
CP54055
Country
Mexico
Facility Name
Hospital Central Militar
City
Mexico City
State/Province
Federal District
Country
Mexico
Facility Name
Hospital General de México
City
México City
State/Province
Federal District
ZIP/Postal Code
CP 06726
Country
Mexico
Facility Name
Instituto Dermatólogico de Jalisco "Dr. Jose Barba Rubio"
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
CP45190
Country
Mexico
Facility Name
Hospital Dr. Ángel Leaño
City
Zapopan
State/Province
Jalisco
ZIP/Postal Code
CP45200
Country
Mexico
Facility Name
MIRC/OCA Hospital
City
Monterrey
State/Province
Nuevo León
ZIP/Postal Code
CP64000
Country
Mexico
Facility Name
Centro de Dermatología de Monterrey
City
Monterrey
State/Province
Nuevo León
ZIP/Postal Code
CP64460
Country
Mexico
Facility Name
Hospital Universitario "José E. González"
City
Monterrey
State/Province
Nuevo León
ZIP/Postal Code
CP64460
Country
Mexico
Facility Name
Unidad de Investigación en Salud
City
Chihuahua
ZIP/Postal Code
CP31205
Country
Mexico
Facility Name
Hospital Ignacio Morones Prieto SLP
City
San Luis Potosí
ZIP/Postal Code
CP 78240
Country
Mexico

12. IPD Sharing Statement

Citations:
PubMed Identifier
23377392
Citation
Tschen EH, Bucko AD, Oizumi N, Kawabata H, Olin JT, Pillai R. Efinaconazole solution in the treatment of toenail onychomycosis: a phase 2, multicenter, randomized, double-blind study. J Drugs Dermatol. 2013 Feb;12(2):186-92.
Results Reference
derived

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

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