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Study of Different Doses of a Novel Treatment for Onychomycosis

Last updated on November 21, 2019

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Study Location
Academic Dermatology Associates
Albuquerque, New Mexico, 87106 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Subungual Onychomycosis Distal
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 Institutional Review Board/Ethics
Committee.

2. Male or female subjects of any race at least 18 years of age but not older than 65
years of age.

3. 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 a dermatophyte.

4. Onychomycosis involving 20-60% of the affected great toenail as determined at
baseline (Day 1) 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:

1. Topical antifungal applied to the feet (does not include antifungals for
treatment of T. pedis during the study): 4 weeks

2. 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:

1. Corticosteroids (including intramuscular injections): 2 weeks

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

3. 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

NCT00679770
Pfizer
Completed
Study of Different Doses of a Novel Treatment for Onychomycosis

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Descriptive Information
Brief Title  ICMJE Study of Different Doses of a Novel Treatment for Onychomycosis
Official Title  ICMJE A Randomized, Double-blind, Vehicle-controlled, Multi-center Study To Evaluate The Safety And Efficacy Of Topically Applied An2690 2.5%, 5.0%, And 7.5% Solutions Vs. Vehicle 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 2.5%, 5.0%, and 7.5% AN2690 Solutions compared to the vehicle alone in the treatment of distal, subungual onychomycosis of the great target toenail.
Detailed Description

The intent is for all subjects to complete a 180 day treatment period consisting of 90 consecutive days of once daily treatment with their assigned study treatment followed by an additional 90 days of three times weekly dosing, even if the treated toenail(s) is evaluated as a "complete responder" prior to the end of treatment 180 day treatment period.

At the end of the 180-Day treatment period, subjects who remain in the study will be classified as complete responders, partial responders, or non-responders. All complete or partial responders will continue to be followed for an additional 180 days until the last evaluation for inclusion in the final analysis.

Periodic efficacy and local tolerance evaluations of the test medication will be performed of the target great toenail and all other treated toenails. KOH wet mounts and fungal cultures from the treatment-targeted great toenail will be performed on the same schedule.

Subjects will also be queried for adverse events and evaluated for application site reactions. Clinical laboratory assessment for safety will be made at Screening, periodically throughout the study, and upon premature discontinuation from the study.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Distal, Subungual Onychomycosis
Intervention  ICMJE
  • Drug: AN2690, 2.5%
    Once daily application for 90 days and 3 x weekly for 90 days
  • Drug: AN2690, 5%
    Once daily application for 90 days and 3 x weekly for 90 days
  • Drug: AN2690, 7.5%
    Once daily application for 90 days and 3 x weekly for 90 days
  • Drug: Vehicle
    Once daily application for 90 days and 3x weekly for 90 days
Study Arms  ICMJE
  • Experimental: Group 1
    AN2690 Solution: 2.5%
    Intervention: Drug: AN2690, 2.5%
  • Experimental: Group 2
    AN2690 Solution: 5%
    Intervention: Drug: AN2690, 5%
  • Experimental: Group 3
    AN2690 Solution: 7.5%
    Intervention: Drug: AN2690, 7.5%
  • Placebo Comparator: Group 4
    AN2690 Solution Vehicle
    Intervention: Drug: Vehicle
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 15, 2008)
28
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 31, 2007
Actual Primary Completion DateAugust 31, 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Witnessed, signed informed consent approved by Institutional Review Board/Ethics Committee.
  2. Male or female subjects of any race at least 18 years of age but not older than 65 years of age.
  3. 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 a dermatophyte.
  4. Onychomycosis involving 20-60% of the affected great toenail as determined at baseline (Day 1) 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:

    1. Topical antifungal applied to the feet (does not include antifungals for treatment of T. pedis during the study): 4 weeks
    2. 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:

    1. Corticosteroids (including intramuscular injections): 2 weeks
    2. Antifungals for treatment of onychomycosis or any systemic antifungal with known activity against dermatophyte: 24 weeks
    3. 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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00679770
Other Study ID Numbers  ICMJE AN2690-ONYC-200A
C3371002 ( Other Identifier: Alias Study Number )
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateFebruary 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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