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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dow Pharmaceutical Sciences
ClinicalTrials.gov Identifier:
NCT00777868
First received: October 20, 2008
Last updated: June 20, 2012
Last verified: June 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Onychomycosis
 Drug: Low Strength IDP-108
Drug: High Strength IDP-108
Drug: High Strength IDP-108 under occlusion
Drug: Vehicle
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Further study details as provided by Dow Pharmaceutical Sciences:

Primary Outcome Measures:
  • Change from baseline in area of infected nail [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in mycological results [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Enrollment: 135
Study Start Date: October 2007
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00777868

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

No publications provided by Dow Pharmaceutical Sciences

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Dow Pharmaceutical Sciences
ClinicalTrials.gov Identifier: NCT00777868     History of Changes
Other Study ID Numbers: DPSI-IDP-108-P2-01
Study First Received: October 20, 2008
Last Updated: June 20, 2012
Health Authority: Mexico: Ministry of Health

Additional relevant MeSH terms:
Onychomycosis
Tinea
Dermatomycoses
Skin Diseases, Infectious
 Infection
Mycoses
Nail Diseases
Skin Diseases

ClinicalTrials.gov processed this record on June 18, 2013