Status:
COMPLETED
Resin vs. Amorolfine vs. Terbinafine Treatment in Onychomycosis
Lead Sponsor:
Helsinki University Central Hospital
Collaborating Sponsors:
Repolar Pharmaceuticals Oy
Conditions:
Onychomycosis
Eligibility:
All Genders
18-90 years
Phase:
PHASE4
Brief Summary
The current study is conducted to corroborate the previous observational clinical trial with more valid methods and a more clinically relevant experimental design. This study aims to compare efficacy,...
Detailed Description
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 on...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
129 Patients enrolled
Trial Details
Trial ID
NCT01851590
Start Date
October 1 2013
End Date
October 1 2014
Last Update
November 30 2015
Active Locations (2)
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1
Vääksyn Lääkärikeskus
Vääksy, Vääksy, Finland, FI-17200
2
Vääksyn Lääkärikeskus
Vääksy, Finland, FI-17200