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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by National Taiwan University Hospital
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01929187
First received: August 22, 2013
Last updated: NA
Last verified: July 2013
History: No changes posted
  Purpose

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.


Condition Intervention
Onycomycosis
Drug: Phytonail
Drug: Loceryl

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Mycological cure [ Time Frame: At week 16 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • The treatment success rate of the target toenail [ Time Frame: At Week16 and Week 24. ] [ Designated as safety issue: No ]
    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.

  • The complete cure rate of the target toenail [ Time Frame: At Week 16 and Week 24 ] [ Designated as safety issue: No ]
    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.

  • The CNG (clear nail growth) of the target great toenail [ Time Frame: Week 16 and Week 24 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 72
Study Start Date: February 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Phytonail
Phytonail is a mixture of herbal active ingredients including tea tree oil, lavender oil and Australian blue cypress (ABC) oil with BioEqual carrier system.
Drug: Phytonail
Other Name: herbal ingredients combined with a carrier system (Phytonail)
Active Comparator: amorolfine 5% nail lacquer
5% amorolfine
Drug: Loceryl
Other Name: amorolfine 5% nail lacquer (Loceryl)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01929187

Contacts
Contact: shiu-lan Wang, Master +886+975212275 belle896106@yahoo.com.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Chiu-Nun Chen    +886+2-23562141    derm@ntuh.gov.tw   
Principal Investigator: Jin-Bon Hong, MD         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Jin-Bon Hong, MD Department of Dermatology, National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01929187     History of Changes
Other Study ID Numbers: 201207030MSA
Study First Received: August 22, 2013
Last Updated: August 22, 2013
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
Onychomycosis, BioEqual carrier system, amorolfine.

Additional relevant MeSH terms:
Tinea
Onychomycosis
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Nail Diseases
Skin Diseases
Amorolfine
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014