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Safety and Efficacy Evaluation of Topically Applied AN2690 Solutions for Subjects With Onychomycosis

Last updated on February 22, 2019

FOR MORE INFORMATION
Study Location
University of Alabama at Birmingham
Birmingham, Alabama, 35233 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Onychomycosis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Witnessed, signed informed consent approved by Institutional Review Board/Ethics
Committee

- A signed Health Insurance Portability and Accountability Act (HIPAA) authorization
form which permits the use and disclosure of subject's individually identifiable
health information for those enrolled in the United States of America

- Male or female subjects of any race 18 -65 years of age

- Subjects with a diagnosis of onychomycosis of at least one great toenail and with a
positive KOH wet mount and a positive fungal culture for dermatophyte species

- Onychomycosis involving 20-60% of the affected great toenail as determined at baseline
(Day1) by visual inspection after the nail has been trimmed

- The combined thickness of the distal nail plate and the associated hyperkeratotic nail
bed

- 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

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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

- 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

- Subjects with chronic moccasin type of T. pedis

- Subjects with a history of having failed any previous topical antifungal therapy for
their onychomycosis

- Diabetes mellitus requiring treatment other than diet and exercise

- 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:

1. Topical antifungal applied to toenails (does not include antifungals for
treatment of T. pedis): 12 weeks

2. Anti-inflammatories, corticosteroids, topical immunomodulators (in the treatment
area): 2 weeks

- 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:

1. Corticosteroids (including intramuscular injections): 2 weeks

2. Antifungals for treatment of onychomycosis or any systemic antifungal with known
activity against dermatophyte species: 24 weeks

3. Systemic immunomodulators: 4 weeks

- Treatment of any type for cancer within the last 6 months

- History of any significant internal disease

- Subjects with a medical history of current or past psoriasis of the skin and/or nails

- Concurrent lichen planus

- 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

- Nail or anatomic abnormalities of the toe, e.g., genetic nail disorders, primentary
disorders, onychogryphosis, trauma to the nail(s) to be treated

- AIDS or AIDS related complex

- History of street drug or alcohol abuse

- Any subject not able to meet the study attendance requirements

- 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

NCT00680134
Pfizer
Completed
Safety and Efficacy Evaluation of Topically Applied AN2690 Solutions for Subjects With Onychomycosis

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Pfizer Clinical Trials Contact Center

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[email protected]

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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]

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