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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%
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. Subjects must meet all of the following criteria to be included in the study:
  2. Witnessed, signed informed consent approved by Ethics Committee.
  3. 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.
  4. For Cohorts 1 and 2, subjects with a diagnosis of onychomycosis of at least one great toenail and with a positive KOH wet mount from that nail. For Cohort 3, subjects must have a diagnosis of onychomycosis of at least one great toenail and a positive KOH wet mount AND fungal culture from that nail.
  5. Onychomycosis involving 20-60% of the affected great toenail as determined by visual inspection after the nail has been trimmed.
  6. The combined thickness of the distal nail plate and the associated hyperkeratotic nail bed <3 mm.
  7. 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.
  8. 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

  • Instituto Dermatologico Jalisciense
  • IMIC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Group 1

Arm Description

AN2690 Solution, 5.0%

Outcomes

Primary Outcome Measures

Clinical Evidence of Complete Clearance of the Treatment-targeted Great Toenail Plus a Negative Fungal Culture at Day 360
Proportion of subjects with a clinical assessment of a clear (completely normal) nail unit plus a negative fungal culture from the treatment-targeted toenail at Day 360.

Secondary Outcome Measures

Clear Nail Growth of the Targeted Toenail
Clear nail was measured on digital images as the distance in millimeters from the proximal nail fold to the proximal limit of the disease as marked by the Investigator. New Clear Nail Growth (CNG) was calculated from the clear nail measurements.
Mycological Evaluations (Negative Potassium Hydroxide (KOH) and Negative Fungal Culture) Compared to Baseline
Number of subjects with negative KOH, and number of subjects with negative fungal cultures.
Mycological Evaluations (Negative KOH and Negative Fungal Culture) Compared to Baseline
Number of subjects with negative KOH, and number of subjects with negative fungal cultures.
Mycological Evaluations (Negative KOH and Negative Fungal Culture) Compared to Baseline
Number of subjects with negative KOH, and number of subjects with negative fungal cultures.
Mycological Evaluations (Negative KOH and Negative Fungal Culture) Compared to Baseline
Number of subjects with negative KOH, and number of subjects with negative fungal cultures.
Length of Time to Clinical Evaluation of Clear or at Least 5 mm of CNG
Length of time to clinical evaluation of clear or at least 5 mm of CNG.

Full Information

First Posted
January 14, 2011
Last Updated
November 13, 2018
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01278394
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
March 2007 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (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 5.0% AN2690 Solution in the treatment of distal, subungual onychomycosis of the great target toenail.
Detailed Description
In this cohort, only the targeted great toenail identified at Baseline prior to the commencement of treatment from culture results collected at the Screening visit were evaluated for primary efficacy whereas all treated toenails were evaluated for safety. At each visit, the investigator was asked to make a clinical evaluation of the targeted great nail, marking whether or not they considered the nail to be clear of onychomycosis. This evaluation was the basis for determining whether or not study medication should be dispensed at the visit. This record includes information only for Cohort 3 (5% solution) of the study. Cohorts 1 and 2, are described in NCT00679523 (7.5% solution). No comparison was made between Cohorts 1&2 and Cohort 3.

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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
AN2690 Solution, 5.0%
Intervention Type
Drug
Intervention Name(s)
AN2690 Solution, 5.0%
Intervention Description
Once daily application for 360 days
Primary Outcome Measure Information:
Title
Clinical Evidence of Complete Clearance of the Treatment-targeted Great Toenail Plus a Negative Fungal Culture at Day 360
Description
Proportion of subjects with a clinical assessment of a clear (completely normal) nail unit plus a negative fungal culture from the treatment-targeted toenail at Day 360.
Time Frame
Day 360
Secondary Outcome Measure Information:
Title
Clear Nail Growth of the Targeted Toenail
Description
Clear nail was measured on digital images as the distance in millimeters from the proximal nail fold to the proximal limit of the disease as marked by the Investigator. New Clear Nail Growth (CNG) was calculated from the clear nail measurements.
Time Frame
Day 360
Title
Mycological Evaluations (Negative Potassium Hydroxide (KOH) and Negative Fungal Culture) Compared to Baseline
Description
Number of subjects with negative KOH, and number of subjects with negative fungal cultures.
Time Frame
Day 90
Title
Mycological Evaluations (Negative KOH and Negative Fungal Culture) Compared to Baseline
Description
Number of subjects with negative KOH, and number of subjects with negative fungal cultures.
Time Frame
Day 180
Title
Mycological Evaluations (Negative KOH and Negative Fungal Culture) Compared to Baseline
Description
Number of subjects with negative KOH, and number of subjects with negative fungal cultures.
Time Frame
Day 270
Title
Mycological Evaluations (Negative KOH and Negative Fungal Culture) Compared to Baseline
Description
Number of subjects with negative KOH, and number of subjects with negative fungal cultures.
Time Frame
Day 360
Title
Length of Time to Clinical Evaluation of Clear or at Least 5 mm of CNG
Description
Length of time to clinical evaluation of clear or at least 5 mm of CNG.
Time Frame
Baseline to 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: Subjects must meet all of the following criteria to be included in the study: 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. For Cohorts 1 and 2, subjects with a diagnosis of onychomycosis of at least one great toenail and with a positive KOH wet mount from that nail. For Cohort 3, subjects must have a diagnosis of onychomycosis of at least one great toenail and a positive KOH wet mount AND fungal culture 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
Instituto Dermatologico Jalisciense
City
Guadalajara
Country
Mexico
Facility Name
IMIC
City
Mexico City
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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