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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00680134
Recruitment Status : Completed
First Posted : May 19, 2008
Last Update Posted : February 20, 2018
Information provided by (Responsible Party):

Brief Summary:
The 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.

Condition or disease Intervention/treatment Phase
Onychomycosis Drug: AN2690 Phase 2

Detailed Description:
The 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 : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : June 30, 2006
Actual Primary Completion Date : August 31, 2007
Actual Study Completion Date : August 31, 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Tavaborole

Arm Intervention/treatment
Experimental: Group/Cohort 1
AN2690 1% Solution (30 subjects)
Drug: AN2690
AN2690 1% Solution, once daily for 180 days

Experimental: Group/Cohort 2
AN2690 5% Solution (30 subjects)
Drug: AN2690
AN2690 5% Solution, once daily for 30 days; 3x weekly for 150 days

Primary Outcome Measures :
  1. Complete or partial clinical evidence of great toenail clearance or at least 2 mm of fungal clear linear great toenail growth plus a negative fungal culture from the treatment targeted toenail at the End-of-treatment (Day 180) [ Time Frame: Day 180 ]

Secondary Outcome Measures :
  1. Evaluations of mycological response, changes from baseline linear toenail growth, proportion of subjects who are successful "Complete Responders" [ Time Frame: Day 180 ]

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00680134

United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
United States, California
University of California, San Francisco
San Francisco, California, United States, 94143-0517
United States, New Mexico
Academic Dermatology Associates
Albuquerque, New Mexico, United States, 87106
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
United States, Texas
DermResearch, Inc.
Austin, Texas, United States, 78759
J&S Studies
Bryan, Texas, United States, 77802
Endeavor Clinical Trials, PA & San Antonio Podiatry Associates, PC
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Responsible Party: Pfizer Identifier: NCT00680134     History of Changes
Other Study ID Numbers: AN2690-ONYC-203
C3371007 ( Other Identifier: Alias Study Number )
First Posted: May 19, 2008    Key Record Dates
Last Update Posted: February 20, 2018
Last Verified: February 2018

Keywords provided by Pfizer:
Fungal Nail

Additional relevant MeSH terms:
Skin Diseases, Infectious
Nail Diseases
Skin Diseases
Pharmaceutical Solutions
Antifungal Agents
Anti-Infective Agents