A Dose-Ranging Study Evaluating the Safety and Efficacy of IDP-108 in Patients With Onychomycosis
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00777868 |
Recruitment Status :
Completed
First Posted : October 22, 2008
Last Update Posted : June 22, 2012
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | 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 (Clinical Trial) |
Actual Enrollment : | 135 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Study Start Date : | October 2007 |
Actual Primary Completion Date : | April 2009 |
Actual Study Completion Date : | April 2009 |
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 |
- Change from baseline in area of infected nail [ Time Frame: 9 months ]
- Change from baseline in mycological results [ Time Frame: 9 months ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00777868
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 | |
MIRC/OCA Hospital | |
Monterrey, Nuevo León, Mexico, CP64000 | |
Centro de Dermatología de Monterrey | |
Monterrey, Nuevo León, Mexico, CP64460 | |
Hospital Universitario "José E. González" | |
Monterrey, Nuevo León, Mexico, CP64460 | |
Unidad de Investigación en Salud | |
Chihuahua, Mexico, CP31205 | |
Hospital Ignacio Morones Prieto SLP | |
San Luis Potosí, Mexico, CP 78240 |
Responsible Party: | Dow Pharmaceutical Sciences |
ClinicalTrials.gov Identifier: | NCT00777868 |
Other Study ID Numbers: |
DPSI-IDP-108-P2-01 |
First Posted: | October 22, 2008 Key Record Dates |
Last Update Posted: | June 22, 2012 |
Last Verified: | June 2012 |
Onychomycosis Tinea Dermatomycoses Skin Diseases, Infectious |
Infection Mycoses Nail Diseases Skin Diseases |