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Study of Different Doses of a Novel Treatment for Onychomycosis

Primary Purpose

Distal, Subungual Onychomycosis

Status
Completed
Phase
Phase 2
Locations
Mexico
Study Type
Interventional
Intervention
AN2690, 2.5%
AN2690, 5%
AN2690, 7.5%
AN2690 Solution Vehicle
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Distal, Subungual Onychomycosis focused on measuring Onychomycosis, Fungal Nail

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Unidad de Investigación en Salud (UIS)
  • Hospital "Dr. Angel Leaño"
  • Instituto Dermatologico Jalisciense
  • Centro Dermatologico Pascua
  • CIF-BIOTEC Medica Sur.
  • IMIC
  • Hospital Universitario Dr. José Eleuterio González
  • MIRC / OCA Hospital
  • ISSEMYM

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Group 1

Group 2

Group 3

Group 4

Arm Description

AN2690 Solution, 2.5%

AN2690 Solution: 5%

AN2690 Solution, 7.5%

AN2690 Solution Vehicle

Outcomes

Primary Outcome Measures

Clinical evidence of complete great toenail clearance or at least fungal-clear great toenail growth ("complete" = 5mm; "partial" = 2mm), plus a negative fungal culture from the treatment-targeted great toenail.

Secondary Outcome Measures

Absence of signs and symptoms of onychomycosis plus a negative fungal culture & negative KOH from the treatment-targeted toenail.

Full Information

First Posted
May 15, 2008
Last Updated
December 10, 2018
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00679965
Brief Title
Study of Different Doses of a Novel Treatment for Onychomycosis
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
February 28, 2006 (Actual)
Primary Completion Date
July 31, 2007 (Actual)
Study Completion Date
July 31, 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distal, Subungual Onychomycosis
Keywords
Onychomycosis, Fungal Nail

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
159 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
AN2690 Solution, 2.5%
Arm Title
Group 2
Arm Type
Experimental
Arm Description
AN2690 Solution: 5%
Arm Title
Group 3
Arm Type
Experimental
Arm Description
AN2690 Solution, 7.5%
Arm Title
Group 4
Arm Type
Placebo Comparator
Arm Description
AN2690 Solution Vehicle
Intervention Type
Drug
Intervention Name(s)
AN2690, 2.5%
Intervention Description
Once daily application for 90 days and 3 x weekly for 90 days
Intervention Type
Drug
Intervention Name(s)
AN2690, 5%
Intervention Description
Once daily application for 90 days and 3 x weekly for 90 days
Intervention Type
Drug
Intervention Name(s)
AN2690, 7.5%
Intervention Description
Once daily application for 90 days and 3 x weekly for 90 days
Intervention Type
Drug
Intervention Name(s)
AN2690 Solution Vehicle
Intervention Description
Once daily application for 90 days and 3x weekly for 90 days
Primary Outcome Measure Information:
Title
Clinical evidence of complete great toenail clearance or at least fungal-clear great toenail growth ("complete" = 5mm; "partial" = 2mm), plus a negative fungal culture from the treatment-targeted great toenail.
Time Frame
Day 180
Secondary Outcome Measure Information:
Title
Absence of signs and symptoms of onychomycosis plus a negative fungal culture & negative KOH from the treatment-targeted toenail.
Time Frame
Day 360

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Witnessed, signed informed consent approved by Institutional Review Board/Ethics Committee. Male or female subjects of any race at least 18 years of age but not older than 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 a dermatophyte. Onychomycosis involving 20-60% of the affected great toenail as determined at baseline (Day 1) by visual inspection after the nail has been trimmed. The combined thickness of the distal nail plate and the associated hyperkeratotic nail bed < 3 mm. 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. Normal or not clinically significant screening safety labs. Exclusion Criteria: 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. Diabetes mellitus requiring treatment other than diet and exercise. Subjects with chronic moccasin type of T. pedis. Subjects with a history of having failed any previous topical antifungal therapy for their onychomycosis. 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 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 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 dermatophyte: 24 weeks 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Unidad de Investigación en Salud (UIS)
City
Chihuahua
Country
Mexico
Facility Name
Hospital "Dr. Angel Leaño"
City
Guadalajara
Country
Mexico
Facility Name
Instituto Dermatologico Jalisciense
City
Guadalajara
Country
Mexico
Facility Name
Centro Dermatologico Pascua
City
Mexico City
Country
Mexico
Facility Name
CIF-BIOTEC Medica Sur.
City
Mexico City
Country
Mexico
Facility Name
IMIC
City
Mexico City
Country
Mexico
Facility Name
Hospital Universitario Dr. José Eleuterio González
City
Monterrey
Country
Mexico
Facility Name
MIRC / OCA Hospital
City
Monterrey
Country
Mexico
Facility Name
ISSEMYM
City
Toluca
Country
Mexico

12. IPD Sharing Statement

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Study of Different Doses of a Novel Treatment for Onychomycosis

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