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Safety and Efficacy Study of Subjects With Onychomycosis of the Great Toenail

Last updated on March 14, 2019

FOR MORE INFORMATION
Study Location
Unidad de Investigación en Salud (UIS)
Chihuahua, , Mexico
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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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

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

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

NCT00679523
Pfizer
Completed
Safety and Efficacy Study of Subjects With Onychomycosis of the Great Toenail

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