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Safety and Efficacy Evaluation of Topically Applied AN2690 Solutions for Subjects With Onychomycosis

Last updated on November 14, 2019

FOR MORE INFORMATION
Study Location
University of Alabama at Birmingham
Birmingham, Alabama, 35233 United States
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

- Witnessed, signed informed consent approved by Institutional Review Board/Ethics
Committee

- A signed Health Insurance Portability and Accountability Act (HIPAA) authorization
form which permits the use and disclosure of subject's individually identifiable
health information for those enrolled in the United States of America

- Male or female subjects of any race 18 -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 dermatophyte species

- Onychomycosis involving 20-60% of the affected great toenail as determined at
baseline (Day1) by visual inspection after the nail has been trimmed

- The combined thickness of the distal nail plate and the associated hyperkeratotic
nail bed

- 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

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

- 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 with chronic moccasin type of T. pedis

- Subjects with a history of having failed any previous topical antifungal therapy for
their onychomycosis

- Diabetes mellitus requiring treatment other than diet and exercise

- 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 toenails (does not include antifungals for
treatment of T. pedis): 12 weeks

2. Anti-inflammatories, corticosteroids, topical immunomodulators (in the treatment
area): 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:

1. Corticosteroids (including intramuscular injections): 2 weeks

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

3. 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

NCT00680134
Pfizer
Completed
Safety and Efficacy Evaluation of Topically Applied AN2690 Solutions for Subjects With Onychomycosis

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Descriptive Information
Brief Title  ICMJE Safety and Efficacy Evaluation of Topically Applied AN2690 Solutions for Subjects With Onychomycosis
Official Title  ICMJE An Open Label, Multi-center Study To Evaluate The Safety And Efficacy Of Topically Applied An2690 1% And 5% Solutions 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 1% and 5% AN2690 solutions in the treatment of distal, subungual onychomycosis of the great toenail.
Detailed DescriptionThe first group of 30 protocol-qualified subjects will be assigned to Treatment Group 1 and given 1% AN2690 Solution. The second group of 30 protocol-qualified subjects will be assigned to Treatment Group 2 and given 5% AN2690 Solution.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Onychomycosis
Intervention  ICMJE
  • Drug: AN2690
    AN2690 1% Solution, once daily for 180 days
  • Drug: AN2690
    AN2690 5% Solution, once daily for 30 days; 3x weekly for 150 days
Study Arms  ICMJE
  • Experimental: Group/Cohort 1
    AN2690 1% Solution (30 subjects)
    Intervention: Drug: AN2690
  • Experimental: Group/Cohort 2
    AN2690 5% Solution (30 subjects)
    Intervention: Drug: AN2690
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)
60
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:

  • Witnessed, signed informed consent approved by Institutional Review Board/Ethics Committee
  • A signed Health Insurance Portability and Accountability Act (HIPAA) authorization form which permits the use and disclosure of subject's individually identifiable health information for those enrolled in the United States of America
  • Male or female subjects of any race 18 -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 dermatophyte species
  • Onychomycosis involving 20-60% of the affected great toenail as determined at baseline (Day1) 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

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
  • 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 with chronic moccasin type of T. pedis
  • Subjects with a history of having failed any previous topical antifungal therapy for their onychomycosis
  • Diabetes mellitus requiring treatment other than diet and exercise
  • 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 toenails (does not include antifungals for treatment of T. pedis): 12 weeks
    2. Anti-inflammatories, corticosteroids, topical immunomodulators (in the treatment area): 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:

    1. Corticosteroids (including intramuscular injections): 2 weeks
    2. Antifungals for treatment of onychomycosis or any systemic antifungal with known activity against dermatophyte species: 24 weeks
    3. 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
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 NCT00680134
Other Study ID Numbers  ICMJE AN2690-ONYC-203
C3371007 ( 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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