Phase 4
Completed N=73
Resin vs. Amorolfine vs. Terbinafine Treatment in Onychomycosis
Onychomycosis
Source: ClinicalTrials.gov NCT01851590 ↗
Enrolled (actual)
73
Serious AEs
0.0%
Results posted
Nov 2015
Primary outcomePrimary: Mycological Cure — 17; 28; 16; 13 Percentage of participants — p=<0.05
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, safety, and cost between topically administered 30% resin lacquer for the treatment of dermatophyte toenail onychomycosis and the current "best practices": topical 5% amorolfine and systemic terbinafine.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mycological Cure |
17; 28; 16; 13; 8; 56 | <0.05 sig |
| SECONDARY Clinical Responses to the Treatments |
0; 0; 44; 0; 0; 0 | <0.05 sig |
| SECONDARY Cost-effectiveness 1 |
0.15; 0.21; 0.56 | <0.05 sig |
| SECONDARY Cost-effectiveness 2 |
40.7; 55.2; 52.1 | <0.05 sig |
| SECONDARY Compliance to the Treatment |
100; 96; 100 | <0.05 sig |
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).
Data sourced from ClinicalTrials.gov (NCT01851590). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.