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

Primary Purpose

Onychomycosis

Status
Completed
Phase
Phase 2
Locations
Mexico
Study Type
Interventional
Intervention
AN2690 Solution, 5.0%
AN2690 Solution, 7.5%
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for 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 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

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 Type

Experimental

Experimental

Arm Label

Group 1

Group 2

Arm Description

AN2690 Solution, 5.0%

AN2690 Solution, 7.5%

Outcomes

Primary Outcome Measures

A calculated endpoint of treatment response at Day 180 comprised of the ISGA, clear nail growth and fungal culture results

Secondary Outcome Measures

Mycological and clinical response of "complete responders", "partial responders", and "non-responder".

Full Information

First Posted
May 15, 2008
Last Updated
November 13, 2018
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00679523
Brief Title
Safety and Efficacy Study of Subjects With Onychomycosis of the Great Toenail
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
February 2007 (Actual)

3. Sponsor/Collaborators

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 5.0% and 7.5% AN2690 Solution in the treatment of distal, subungual onychomycosis of the great target toenail.
Detailed Description
The 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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
AN2690 Solution, 5.0%
Arm Title
Group 2
Arm Type
Experimental
Arm Description
AN2690 Solution, 7.5%
Intervention Type
Drug
Intervention Name(s)
AN2690 Solution, 5.0%
Intervention Description
Once daily application for 180 days
Intervention Type
Drug
Intervention Name(s)
AN2690 Solution, 7.5%
Intervention Description
Once daily application for 180 days
Primary Outcome Measure Information:
Title
A calculated endpoint of treatment response at Day 180 comprised of the ISGA, clear nail growth and fungal culture results
Time Frame
Day 180
Secondary Outcome Measure Information:
Title
Mycological and clinical response of "complete responders", "partial responders", and "non-responder".
Time Frame
Days 180

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 Ethics Committee 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 Subjects with a diagnosis of onychomycosis of at least one great toenail and with a positive KOH wet mount from that nail Onychomycosis involving 20-60% of the affected great toenail as determined 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 dermatophytes: 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
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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Safety and Efficacy Study of Subjects With Onychomycosis of the Great Toenail

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