Ciclopirox 8% hydroxypropyl chitosan (HPCH) is the first topical nail lacquer formulated using the HPCH drug formulation technology. |
This review assesses the efficacy and safety of ciclopirox 8% HPCH in the treatment of mild-to-moderate fungal infections of the nails caused by dermatophytes and/or other ciclopirox-sensitive fungi, without nail matrix involvement. |
In vitro studies found that the application of ciclopirox 8% HPCH nail lacquer improved drug permeation into and/or drug penetration through the nail, relative to water-insoluble ciclopirox 8%, amorolfine 5% and efinaconazole 10% reference lacquers. |
In clinical studies in patients with mild-to-moderate onychomycosis, ciclopirox 8% HPCH was found to be more effective than water-insoluble ciclopirox 8% and amorolfine 5% commercial lacquers, as indicated by higher complete cure, response and mycological cure rates. |
Ciclopirox 8% HPCH was well tolerated. |
Introduction
Ciclopirox
Hydroxypropyl Chitosan Technology
Ciclopirox 8% HPCH Nail Lacquer
Preclinical Studies
Nail Penetration
Ciclopirox 8% HPCH Nail Lacquer Versus Ciclopirox Water-Insoluble Lacquer
Ciclopirox 8% HPCH Nail Lacquer Versus Water-Insoluble Amorolfine 5% Formulation
Ciclopirox 8% HPCH Nail Lacquer Versus Efinaconazole 10% Topical Solution
Antifungal Activity
Study | Efficacy Indexa (CPX vs. MRF)b | ||||
---|---|---|---|---|---|
Trichophyton mentagrophytes var. interdigitale | Trichophyton rubrum | Microsporum canis | Candida parapsilosis | Scopulariopsis brevicaulis | |
Bovine hoof model [23] | 61.3 vs. 32.0 | 61.3 vs. 8.0 | 61.3 vs. 16.0 | 30.6 vs. 1.0 | 30.6 vs. 8.0 |
Healthy human nails [24] | 135.6 vs. 5.2 | 135.6 vs. 1.3 | 135.6 vs. 2.6 | 67.8 vs. 0.16 | 67.8 vs. 1.3 |
Clinical Efficacy
Healthy Subjects
Patients with Onychomycosis
Ciclopirox 8% HPCH Versus Ciclopirox Reference Lacquer
Study design/reference | Time point | Treatment (no. of ITT patients) | Complete cure rate (% of patients)a | Response rate (% of patients)b | Culture conversion to negative (% of patients) | Mycological cure rate (% of patients) |
---|---|---|---|---|---|---|
Randomized, double-blind study/Baran et al. [27] | Week 48 | CPX HPCH (175) | 5.7*c | 24*** | 89*** | |
CPX reference (185) | 3.2c | 17.3 | 91 | |||
Placebo (94) | 0c | 6.4 | 69 | |||
Week 60 | CPX HPCH | 12.7**† | 28.7*† | 79 | ||
CPX reference | 5.8 | 17.3 | 80 | |||
Placebo | 1.3 | 14.7 | 72 | |||
Open-label study/Iorizzo et al. [28] | Week 48 | CPX HPCH (60) | 35‡ | 58.3‡ | 100‡ | |
MRF (60) | 11.7 | 26.7 | 82 |