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

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: NCT00679523
Recruitment Status : Completed
First Posted : May 19, 2008
Last Update Posted : May 19, 2008
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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.

Condition or disease Intervention/treatment Phase
Onychomycosis Drug: AN2690 Solution, 5.0% Drug: AN2690 Solution, 7.5% Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : November 2005
Actual Primary Completion Date : February 2007
Actual Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Tavaborole
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Group 1
AN2690 Solution, 5.0%
Drug: AN2690 Solution, 5.0%
Once daily application for 180 days
Experimental: Group 2
AN2690 Solution, 7.5%
Drug: AN2690 Solution, 7.5%
Once daily application for 180 days

Primary Outcome Measures :
  1. 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 Measures :
  1. Mycological and clinical response of "complete responders", "partial responders", and "non-responder". [ Time Frame: Days 180 ]

Information from the National Library of Medicine

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

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

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): NCT00679523

Unidad de Investigación en Salud (UIS)
Chihuahua, Mexico
Hospital "Dr. Angel Leaño"
Guadalajara, Mexico
Instituto Dermatologico Jalisciense
Guadalajara, Mexico
Centro Dermatologico Pascua
Mexico City, Mexico
CIF-BIOTEC Medica Sur.
Mexico City, Mexico
Mexico City, Mexico
Hospital Universitario Dr. José Eleuterio González
Monterrey, Mexico
MIRC / OCA Hospital
Monterrey, Mexico
Toluca, Mexico
Sponsors and Collaborators
Study Director: Karl Beutner, MD, PhD Pfizer

Responsible Party: Karl Beutner, MD, PhD, Anacor Pharmaceuticals, Inc. Identifier: NCT00679523     History of Changes
Other Study ID Numbers: AN2690-ONYC-201 Cohort 1 & 2
First Posted: May 19, 2008    Key Record Dates
Last Update Posted: May 19, 2008
Last Verified: May 2008

Keywords provided by Pfizer:
Fungal Nail

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