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Sponsored by: |
NanoBio Corporation |
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Information provided by: | NanoBio Corporation |
ClinicalTrials.gov Identifier: | NCT00453271 |
The purpose of the study is to determine whether NB002, 0.25%, and 0.5% are safe and effective in the treatment of distal subungual onychomycosis of the toenail.
Condition | Intervention | Phase |
---|---|---|
Onychomycosis |
Drug: NB-002 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Parallel-Group,Multicenter, Dose-Response, Vehicle-Controlled Study of the Safety and Efficacy of NB-002 in the Treatment of Mild to Moderate Distal Subungual Onychomycosis of the Toenail |
Estimated Enrollment: | 1000 |
Study Start Date: | January 2007 |
Estimated Study Completion Date: | October 2008 |
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
Principal Investigator: | Alicia Barba, MD | International Dermatology Research |
Principal Investigator: | Alicia Bucko, DO | Academic Dermatology Associates |
Principal Investigator: | Richard Pollak, DPM, MS | Endeavor Clinical Trials, PA |
Principal Investigator: | Michael Jarratt, MD | DermResearch Inc. |
Principal Investigator: | Terry Jones, MD | J & S Studies, Inc. |
Principal Investigator: | Robert Kaylor, DPM | Welborne Clinic |
Principal Investigator: | Steven Kempers, MD | Minnesota Clinical Study Center |
Principal Investigator: | Robert Matheson, MD | Oregon Medical Research Center, PC |
Principal Investigator: | Brock McConnehey,, DO | Northwest Clinical Trial |
Principal Investigator: | David Pariser, MD | Virginia Clinical Research, Inc. |
Principal Investigator: | Phoebe Rich, MD | Oregon Dermatology and Research Center |
Principal Investigator: | Dan Stewart, DO | Michigan Center for Research Corp |
Principal Investigator: | Leonard Swinyer, MD | Dermatology Research Center, Inc. |
Principal Investigator: | Robert Bissonette, MD | Innovaderm Research Inc. |
Principal Investigator: | Sylvia Garnis-Jones, MD | EntraLogix Clinical Group Inc. |
Principal Investigator: | David Gratton, MD | International Dermatology Research, Inc. |
Principal Investigator: | Lyn Guenther, MD | The Guenther Dermatology Research Centre |
Principal Investigator: | Rod Kunynetz, MD | Ultranova Skincare |
Principal Investigator: | Charles Lynde, MD | Lynderm Research, Inc. |
Principal Investigator: | Richard Langley, MD | Eastern Canada Cutaneous Research Associates, LTD |
Principal Investigator: | Kim Papp, MD | K. Papp Clinical Research |
Principal Investigator: | Yves Poulin, MD | Centre de Reeberche Dermatologique du Quebec Metropolitain (CRDQ) |
Principal Investigator: | Wayne Gulliver, MD | Newlab Clinical Research Inc. |
Principal Investigator: | R G Sibbald, MD | Dermatology Clinic |
Study ID Numbers: | NB-002-002 |
Study First Received: | March 26, 2007 |
Last Updated: | December 6, 2007 |
ClinicalTrials.gov Identifier: | NCT00453271 History of Changes |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada |
chronic persistent infection of the nail bed or plate |
Mycoses Skin Diseases, Infectious Nail Diseases Onychomycosis |
Skin Diseases Tinea Dermatomycoses |
Mycoses Skin Diseases, Infectious Nail Diseases Onychomycosis |
Skin Diseases Infection Tinea Dermatomycoses |