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

Last updated on November 21, 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.
Show details

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.
Show details

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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Descriptive Information
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 SummaryThe 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 DescriptionThe 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
  • Drug: AN2690 Solution, 5.0%
    Once daily application for 180 days
  • Drug: AN2690 Solution, 7.5%
    Once daily application for 180 days
Study Arms  ICMJE
  • Experimental: Group 1
    AN2690 Solution, 5.0%
    Intervention: Drug: AN2690 Solution, 5.0%
  • Experimental: Group 2
    AN2690 Solution, 7.5%
    Intervention: Drug: AN2690 Solution, 7.5%
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
 (submitted: May 16, 2008)
60
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2007
Actual Primary Completion DateFebruary 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  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

Exclusion Criteria:

  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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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 CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyKarl Beutner, MD, PhD, Anacor Pharmaceuticals, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS AccountPfizer
Verification DateNovember 2018

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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

BY EMAIL

Contact

[email protected]

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