A Randomized Study to Evaluate the Efficacy of Herbal Ingredients Combined With a Carrier System (Phytonail) Compared With Amorolfine 5% Nail Lacquer (Loceryl) in the Treatment of Toenail Onychomycosis

Launched by NATIONAL TAIWAN UNIVERSITY HOSPITAL · Aug 22, 2013

Keywords

ClinConnect Summary

Subjects aged 20-65 years with toenail onychomychosis involved at least one great toenail will be recruited in the study. Approximately 200 subjects will be screened, in order to randomize 72 eligible subjects. Allowing for approximately 20% drop-outs, it is estimated that for completing 60 eligible subjects, approximately 72 subjects would be enrolled. Subjects must meet all the inclusion criteria and none of the exclusion criteria to receive treatment assignment.

Procedures:

Explain study and obtain written informed consent: Screening Review inclusion/exclusion criteria including prior ...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • The subject must meet ALL the criteria listed below both at Screening and Baseline (Day 1)
• • 1. Subjects must be aged 20 to 65 years at Screening, and can be either sex.
• • 2. Subjects must have onychomycosis, that (a) involves at least one great toenail (if two great toenails are infected, the one with greater involvement will be selected as target nail), and (b) has been mycologically confirmed at Screening Phase (positive potassium hydroxide (KOH) preparation and culture positive for dermatophytes, Candida spp., or molds).
• • 3. Subjects must have the target great toenail capable of growing.
• • 4. Subjects must be able to apply the study drugs to their toenails.
• • 5. Subjects must be willing to sign the informed consent form and be able to adhere to dose and visit schedules during the study
• • 6. Subjects must agree to use no other products including nail polish applied to the toenails during the study.
• Exclusion Criteria:
• • The subject will not be selected for the study if ANY of the criteria listed below are met at Screening and/or Baseline (Day 1)
• • 1. Subjects with a structural deformity of the target great toenail, including but not limited to genetic nail disorders, onychogryphosis, traumatic nail dystrophy, and/or any other abnormalities that in the investigator's judgment may interfere with efficacy assessments.
• • 2. Subjects with a current or past history of psoriasis and /or lichen planus.
• • 3. Subjects with a history of treatment failure (defined as no recognized increase in clean nail growth) after completion of ≧3 months of any oral antifungals.
• • 4. Subjects have controlled diabetes with HbA1C≧8%.
• • 5. Subjects with significant peripheral vascular disease or peripheral circulatory impairment, as evidenced by absence of dorsalis pedis or posterior tibial pulses.
• • 6. Subject with a history of immunosuppression or presence of a serious concurrent medical condition that might adversely affect the evaluation of treatment response.
• • 7. Subjects with chronic tinea pedis (eg, moccasin type) that in the investigator's judgment would require systemic treatment.
• • 8. Subjects who have received any treatment listed below more recently than the indicated washout period or who must continue to receive such treatments Systemic antifungal treatments (24 weeks prior to Screening) Topical antifungal agents applied to the toenails, excluding antifungal agents for the treatment of tinea pedis (4 weeks prior to Screening) Investigational drugs (4 weeks prior to Screening) Oral or intramuscular corticosteroid or immunosuppressive agents (2 weeks prior to Day 1) Topical antifungal agents for the treatment of tinea pedis (prior to Day 1) Topical anti-inflammatory, topical corticosteroids, and topical immunosuppressive agents applied to the feet (2 weeks prior to Day 1)
• • 9. Subject with a history of hypersensitivity to morpholine antifungal agents or essential herbal oil;
• • 10. Women who are breast-feeding, pregnant, or intended to become pregnant; and
• • 11. Subjects who are unable to comply with the treatment regimen.
• • 12. Subjects who are participating in any other clinical study.
• • 13. Subjects who are part of the staff personnel directly involved with the study.