Resin vs. Amorolfine vs. Terbinafine Treatment in Onychomycosis
Launched by HELSINKI UNIVERSITY CENTRAL HOSPITAL · May 9, 2013
Trial Information
Current as of May 30, 2025
Completed
Keywords
ClinConnect Summary
The aim of this prospective, investigator-blinded, randomized and controlled clinical trial is to explore potential differences between 5 % amorolfine and 30 % resin lacquer in topical treatment of onychomycosis. In addition, topical treatment methods are compared with the most effective 'drug of choice' for onychomycosis according the current guidelines i.e. oral medication with terbinafine.
Altogether 90 patients (the aim is to collect the 30 patients per group) who have culture or potassium hydroxide (KOH) stain verified dermatophyte onychomycosis are randomly allocated into 3 treatment...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Positive dermatophyte culture in the beginning of the study obtained from the toenail sample.
- • Positive KOH stain in the beginning of the study obtained from the toenail sample.
- Exclusion Criteria:
- • Any other nail disease than dermatophyte culture or KOH stain verified onychomycosis
- • Onychomycosis caused by yeasts or nondermatophyte molds
- • Kidney failure determined by plasma creatinine level (P-Krea \> 100 μmol/l)
- • Liver failure determined by plasma γ-glutamyltransferase level (P-GT \> 120 U/I)
- • Sensitivity or allergy to Resin, Amorolfine or Terbinafine
- • Potential adverse cross-reaction of Terbinafine, Amorolfine or Resin with the patient's permanent medication
- • Presence of total dystrophic onychomycosis (TDO)
- • Any topical or oral antifungal treatment within the 6 months before the beginning of the study (washout period \> 6 months).
About Helsinki University Central Hospital
Helsinki University Central Hospital (HUCH) is a leading academic medical institution in Finland, dedicated to advancing healthcare through innovative research and clinical excellence. As a pivotal sponsor of clinical trials, HUCH integrates cutting-edge medical practices with rigorous scientific inquiry, fostering collaborations between researchers, healthcare professionals, and patients. The hospital is committed to enhancing patient outcomes and contributing to the global body of medical knowledge by conducting high-quality, ethically sound clinical studies across a diverse range of therapeutic areas. With a strong emphasis on education and training, HUCH plays a vital role in shaping the next generation of healthcare leaders and researchers.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Vääksy, , Finland
Patients applied
Trial Officials
Janne J. Jokinen, MD, PhD
Principal Investigator
Department of Cardiac Surgery, Heart and Lung Centre, Helsinki University Hospital, FI-00029, Helsinki, Finland
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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