Itraconazole Tablets Vs. Itraconazole Capsules vs. Placebo in Onychomycosis of the Toenail.
Public ClinicalTrials.gov record NCT00356915. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase III Randomized, Evaluator-Blind, Parallel Group Study of the Safety and Efficacy of Itraconazole Tablets, Itraconazole Capsules and Placebo in the Treatment of Onychomycosis of the Toenail.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Onychomycosis is a common condition accounting for approximately half of all nail disorders. It is most commonly caused by dermatophytes. Itraconazole has been approved for the treatment of onychomycosis in the United States with an approved dosage regimen for the treatment of onychomycosis of the toenail of once daily (QD) treatment with 200mg of itraconazole (two 100 mg capsules) for 12 weeks. Barrier Therapeutics has developed a 200 mg tablet which could be used in a more convenient one-tablet-per-day dosing regimen. This clinical trial will compare the efficacy and safety of this new tablet formulation with itraconazole capsules and placebo.
Study identification
- NCT ID
- NCT00356915
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,381 participants
Conditions and interventions
Conditions
Interventions
- Itraconazole 100mg capsules Drug
- Itraconazole 200mg tablets Drug
- Placebo tablets Drug
Drug
Eligibility (public fields only)
- Age range
- 16 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 2006 (Type not available)
- Primary completion
- Oct 2008 (Actual)
- Completion
- Oct 2008 (Actual)
- Last update posted
- Feb 9, 2017
2006 – 2008
United States locations
- U.S. sites
- 52
- U.S. states
- 26
- U.S. cities
- 46
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Radiant Research -Birmingham | Birmingham | Alabama | 35209 | — |
| University of Alabama School of Medicine | Birmingham | Alabama | 35233 | — |
| Radiant Research - Tucson | Tuscon | Arizona | 85710 | — |
| Burke Pharmaceutical Research | Hot Springs | Arkansas | 71913 | — |
| East Bay Dermatology Medical Group Inc. | Fremont | California | 94538 | — |
| Skin Surgey Medical Group | San Diego | California | 92117 | — |
| Therapeutics Clinical Research | San Diego | California | 92123 | — |
| University of California | San Francisco | California | 94143-0517 | — |
| Radiant Research - Santa Rosa | Santa Rosa | California | 95405 | — |
| Meridian Skincare | Englewood | Colorado | 80112 | — |
| The Savin Center | New Haven | Connecticut | 06511 | — |
| Dr. Stephen Horwitz | Aventure | Florida | 33180 | — |
| International Dermatology Research Inc. | Miami | Florida | 33144 | — |
| FMX Research Corporation | Miami | Florida | 33175 | — |
| Advanced Dermatology and Cosmetic Surgery | Ormond Beach | Florida | 32174 | — |
| Radiant Research - St. Petersburg | St. Petersburg | Florida | 33781 | — |
| Radiant Research - West Palm Beach | West Palm Beach | Florida | 33407 | — |
| Radiant Research - Atlanta West | Austell | Georgia | 30106 | — |
| Gwinnett Clinical Research Center Inc. | Snellville | Georgia | 30078 | — |
| Northwest Clinical Trials | Boise | Idaho | 83704 | — |
| Radiant Research - Chicago | Chicago | Illinois | 60610 | — |
| Radiant Research - Kansas City | Overland Park | Kansas | 66215 | — |
| Dr. David Fivenson | Ann Arbour | Michigan | 48103 | — |
| Skin and Vein Center | Troy | Michigan | 48083 | — |
| Minnesota Clinical Study Center | Fridley | Minnesota | 55432 | — |
| VA Medical Center | Minneapolis | Minnesota | 55417 | — |
| Dr. Eduardo Tschen | Albuquerque | New Mexico | 87106 | — |
| Skin Specialty Group | New York | New York | 10021 | — |
| Columbia University Medical Center | New York | New York | 10032 | — |
| Dermatology Consulting Services | High Point | North Carolina | 27262 | — |
| Dermatology Clinical Research Center | Cincinnati | Ohio | 45219 | — |
| Radiant Research - Cincinnati | Cincinnati | Ohio | 45249 | — |
| Northwest Cutaneous Research | Portland | Oregon | 97210 | — |
| Oregon Medical Research Center | Portland | Oregon | 97223 | — |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | — |
| Radiant Research - Anderson | Anderson | South Carolina | 29621 | — |
| Radiant Research - Greenville | Greenville | South Carolina | 29617 | — |
| Dr. J. M. Humeniuk | Greer | South Carolina | 29651 | — |
| Dermatology East | Germantown | Tennessee | 38138 | — |
| Dermatology Associates of Knoxville | Knoxville | Tennessee | 37917 | — |
| Tennessee Clinical Research Center | Nashville | Tennessee | 37215 | — |
| DermResearch Inc. | Austin | Texas | 78759 | — |
| Dr. Terry Jones | Bryan | Texas | 77802 | — |
| Radiant Research - Dallas North | Dallas | Texas | 75231 | — |
| Dr. Stephen Miller | San Antoinio | Texas | 78229 | — |
| Endeavor Clinical Trials | San Antonio | Texas | 78229 | — |
| Dermatology Research Center | Salt Lake City | Utah | 84124 | — |
| South Valley Dermatology Center | West Jordan | Utah | 84088 | — |
| Pariser Dermatology Specialists Ltd. | Norfolk | Virginia | 235507 | — |
| Radiant Research - Tacoma | Tacoma | Washington | 98499 | — |
| Madison Skin and Research Inc. | Madison | Wisconsin | 53719 | — |
| Advanced Healthcare S. C. | Milwaukee | Wisconsin | 53209 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 16 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00356915, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 9, 2017 · Synced Oct 19, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00356915 live on ClinicalTrials.gov.