Onycomycosis Clinical Trial
Official title:
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
Background: Onychomycosis, the most common nail disorder, is a superficial fungal infection
affecting toenails more than fingernails. Onychomycosis can cause pain and discomfort and
has the potential to be a source of morbidity. Although oral antifungal agents achieve a
better complete cure rate for onychomycosis, many patients are worried about the side
effects and unwilling to take oral medications. Phytonail is a mixture of herbal active
ingredients including tea tree oil, lavender oil and Australian blue cypress oil with
BioEqual carrier system. A preliminary trial has shown a 100% KOH negative rate in 32 nails
after 12 weeks of Phytonail therapy. Amorolfine 5% nail lacquer (Loceryl) is a
broad-spectrum morpholine antifungal demonstrated 60-75% mycological cure rate in several
randomized controlled trials for the treatment of toenail onychomycosis.
Objective: To evaluate the efficacy and safety of Phytonail relative to amorolfine 5% nail
lacquer in the treatment of toenail onychomycosis.
Methods: This is a randomized, parallel-group, open-labeled study in adult subjects with
toenail onychomycosis. In this study, 60 eligible patients will be randomized in a 1: 1
ratio to one of the two treatment groups: Phytonail or amorolfine 5% nail lacquer. Before
randomization, patients are to have onychomycosis in at least one great toenail with
positive KOH examination and positive fungal culture. During the treatment phase, Phytonail
will be applied twice daily and amorolfine 5% nail lacquer once weekly for 16 weeks to all
affected toenails. Physician's assessments and photographic analyses will be carried out at
baseline, Week 4, 8, 16, and 24. Mycological evaluation including KOH examination will be
performed at baseline, Week 4, 8, and 16. Fungal culture will be performed at baseline and
for KOH negative patients.
| Status | Recruiting |
| Enrollment | 72 |
| Est. completion date | July 2014 |
| Est. primary completion date | December 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 20 Years to 65 Years |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Taiwan | National Taiwan University Hospital | Taipei |
| Lead Sponsor | Collaborator |
|---|---|
| National Taiwan University Hospital |
Taiwan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Mycological cure | The primary efficacy endpoint of the study is the mycological cure rate of the target great toenail at Week 16. Mycological cure is defined as both negative KOH and negative fungal culture. | At week 16 | No |
| Secondary | The treatment success rate of the target toenail | Treatment success is defined as both almost clear nail (<10% nail involvement) after proper trimming, as determined by the investigator, and negative KOH and negative fungal culture. | At Week16 and Week 24. | No |
| Secondary | The complete cure rate of the target toenail | Complete cure is defined as both completely clear nail (0% nail involvement) after proper trimming, as determined by the investigator, and negative KOH and negative fungal culture. | At Week 16 and Week 24 | No |
| Secondary | The CNG (clear nail growth) of the target great toenail | For other toenail excluding the target toenail, the proportion of nails that are completely clear (0% nail involvement) or almost clear (<10% nail involvement) at Baseline, Week 16 and Week 24. | Week 16 and Week 24 | No |