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Efficacy of Amorolfine in Onychomycosis Treatment: A Mixed-Effects Models and Multivariate Logistic Regression
Chichi Du1,2, Mingming Ding3, Lin Zhang1,2
1Department of Dermatology, Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.
Background:
Onychomycosis (OM) is a common nail infection treated with amorolfine hydrochloride nail lacquer in China. Monitoring drug concentrations and using dermoscopy to evaluate treatment efficacy may provide new insights.
Objective:
The study aims to analyse amorolfine concentrations in nails with mild to moderate OM, assess treatment outcomes using dermoscopy and explore factors influencing drug concentrations and efficacy.
Methods:
Patients with mild to moderate OM confirmed by fungal microscopy were enrolled. Amorolfine nail lacquer was applied twice weekly for 36 weeks. Monthly nail samples measured amorolfine concentrations using liquid chromatography. Dermoscopy was performed before and after treatment to evaluate responses. Mixed-effects models and logistic regression analysed factors affecting drug concentrations and outcomes.
Results:
Ninety-seven nails were included. Amorolfine concentrations increased over time, with higher levels in females, fingernails, 2nd-5th digits and superficial white OM (p < 0.05). Age was a risk factor, while drug concentration and OM type were protective for clinical efficacy (p < 0.05). Peak concentration correlated with clinical (r = 0.487, p = 0.000) and mycological (r = 0.433, p = 0.000) responses. Dermoscopic features improved significantly in successful cases (p < 0.05).
Limitations:
In the assessment of fungal efficacy, only fungal microscopy was used, and fungal cultures were not performed. The study was limited by a small sample size and the lack of a longer follow-up to assess relapse.
Conclusion:
Amorolfine concentrations vary with patient and nail characteristics, influencing efficacy. Dermoscopy is valuable for monitoring OM treatment.
Insights
Amorolfine nail lacquer concentrations in nails vary by patient and nail characteristics, impacting treatment efficacy for onychomycosis (OM). Dermoscopy effectively monitors treatment success in this common fungal infection.
Area of Science:
- Dermatology
- Mycology
- Pharmacokinetics
Background:
- Onychomycosis (OM) is a prevalent nail fungal infection.
- Amorolfine hydrochloride nail lacquer is a common treatment in China.
- Monitoring drug levels and using dermoscopy can enhance understanding of OM treatment.
Purpose of the Study:
- To analyze amorolfine concentrations in nails with mild to moderate OM.
- To assess treatment outcomes using dermoscopy.
- To explore factors influencing drug concentrations and treatment efficacy.
Main Methods:
- Patients with mild to moderate OM underwent treatment with amorolfine nail lacquer (twice weekly for 36 weeks).
- Monthly nail samples were analyzed for amorolfine concentrations via liquid chromatography.
- Dermoscopy was used for pre- and post-treatment evaluation.
Main Results:
- Amorolfine concentrations increased over time, with higher levels observed in females, fingernails, specific digits, and superficial white OM.
- Higher drug concentrations and specific OM types were associated with better clinical efficacy.
- Peak amorolfine concentration positively correlated with clinical and mycological treatment responses.
Conclusions:
- Amorolfine concentrations are influenced by patient and nail-specific factors, affecting treatment outcomes.
- Dermoscopy is a valuable tool for monitoring the efficacy of onychomycosis treatment.
- Fungal cultures were not performed, and the study had limitations including sample size and follow-up duration.
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