Safety and Efficacy Study of Subjects With Onychomycosis of the Great Toenail
Condition: Onychomycosis
MeSH terms: Onychomycosis
Intervention: AN2690 Solution, 5.0%
Intervention description: Once daily application for 360 days
Intervention MeSH terms: Tavaborole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 29.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Onychomycosis; Fungal Nail

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.
    

Eligibility criteria:

        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.