Safety and Efficacy Study of Subjects With Onychomycosis of the Great Toenail
NCT00679523
ABOUT THIS STUDY
FOR MORE INFORMATION
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1. Witnessed, signed informed consent approved by Ethics Committee
2. Male or female subjects of any race at least 18 years of age but not older than 65 years of age at the time of screening
3. Subjects with a diagnosis of onychomycosis of at least one great toenail and with a positive KOH wet mount from that nail
4. Onychomycosis involving 20-60% of the affected great toenail as determined by visual inspection after the nail has been trimmed
5. The combined thickness of the distal nail plate and the associated hyperkeratotic nail bed <3 mm
6. Affected great toenail to be treated is capable of re-growth as documented by history or recent observation of at least 2 mm of growth
7. Normal or not clinically significant screening safety labs
1. Females of childbearing potential not using a highly effective method of birth control
(e.g. implants, injectables, combined oral contraceptives, some intrauterine
contraceptive devices) during the study
2. Diabetes mellitus requiring treatment other than diet and exercise
3. Subjects with chronic moccasin type of T. pedis
4. Subjects with a history of having failed any previous topical antifungal therapy for
their onychomycosis
5. Subjects unwilling to refrain from the use of nail cosmetics such as clear and or
colored nail lacquers from the screening visit until the end of the study.
6. Subjects that have not undergone the specified washout period(s) for the following
topical preparations or subjects who require the concurrent use of any of the
following topical medications:
- Topical antifungal applied to the feet (does not include antifungals for
treatment of T. pedis during the study): 4 weeks
- Anti-inflammatories, corticosteroids, topical immunomodulators: 2 weeks
7. Subjects that have not undergone the specified washout period(s) for the following
systemic medications or subjects who require the concurrent use of any of the
following systemic medications:
- Corticosteroids (including intramuscular injections): 2 weeks
- Antifungals for treatment of onychomycosis or any systemic antifungal with known
activity against dermatophytes: 24 weeks
- Systemic immunomodulators: 4 weeks
8. Treatment of any type for cancer within the last 6 months
9. History of any significant internal disease
10. Subjects with a medical history of current or past psoriasis of the skin and/or nails
11. Concurrent lichen planus
12. Subjects who are known to be allergic to any of the test product(s) or any components
in the test product(s) or history of hypersensitivity or allergic reactions to any of
the study preparations as described in the Investigator's Brochure
13. Nail or anatomic abnormalities of the toe, e.g., genetic nail disorders, primentary
disorders, onychogryphosis, trauma to the nail(s) to be treated
14. AIDS or AIDS related complex
15. History of street drug or alcohol abuse
16. Any subject not able to meet the study attendance requirements
17. Subjects who have participated in any other trial of an investigational drug or device
within 60 days prior to enrollment or participation in a research study concurrent
with this study
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Descriptive Information | |||
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Brief Title ICMJE | Safety and Efficacy Study of Subjects With Onychomycosis of the Great Toenail | ||
Official Title ICMJE | An Open-Label, Rising Multiple-Dose, Multi-Center Study to Evaluate the Safety and Efficacy of Topically Applied AN2690 5.0% and 7.5% Solution for the Treatment of Adult Subjects With Onychomycosis of the Great Toenail | ||
Brief Summary | The purpose of the study is to determine the safety and efficacy of 5.0% and 7.5% AN2690 Solution in the treatment of distal, subungual onychomycosis of the great target toenail. | ||
Detailed Description | The first group of 30 protocol-qualified subjects will be assigned to Treatment Group 1 and given 5% AN2690 Solution. Provided that there is adequate evidence of clinical safety after two weeks of dosing with 5% AN2690 Solution, a second group of 30 protocol-qualified subjects will be assigned to Treatment Group 2 and given 7.5% AN2690 Solution. A third group of 30 subjects will be enrolled and assigned the highest safe concentration of AN2690 evaluated in this study. | ||
Study Type ICMJE | Interventional | ||
Study Phase ICMJE | Phase 2 | ||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | ||
Condition ICMJE | Onychomycosis | ||
Intervention ICMJE |
| ||
Study Arms ICMJE |
| ||
Publications * | Not Provided | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||
Recruitment Information | |||
Recruitment Status ICMJE | Completed | ||
Actual Enrollment ICMJE | 60 | ||
Original Actual Enrollment ICMJE | Same as current | ||
Actual Study Completion Date ICMJE | February 2007 | ||
Actual Primary Completion Date | February 2007 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| ||
Sex/Gender ICMJE |
| ||
Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | ||
Accepts Healthy Volunteers ICMJE | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | Mexico | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT00679523 | ||
Other Study ID Numbers ICMJE | AN2690-ONYC-201 Cohort 1 and 2 | ||
Has Data Monitoring Committee | No | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement ICMJE | Not Provided | ||
Responsible Party | Karl Beutner, MD, PhD, Anacor Pharmaceuticals, Inc. | ||
Study Sponsor ICMJE | Pfizer | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Pfizer | ||
Verification Date | November 2018 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |