Onychomycosis Clinical Trial
Official title:
A Pilot Study - Safety and Efficacy of Nailprotex® for Onychomycosis Treatment
This study was designed to demonstrate the efficacy of this product in non-dermatophyte (Scytalidium dimidiatum) onychomycosis and chronic paronychia treatment in Thai patients.
Onychomycosis is the common superficial fungal skin infection in general population.
According to the previous study, the prevalence of tinea pedis and onychomycosis in general
Thai population were 3.8% and 1.7% respectively. However, this problem has been neglected
for treatment due to asymptomatic clinical manifestations and low effects in quality of
life.
In Thailand, the previous studies reported that the aetiological pathogens of this disorder
were non-dermatophyte mold (51.6%), dermatophyte (36.3%) and yeast (6%). Additionally,
Scytalidium dimidiatum was the majority causative agents in non-dermatophyte mold.
Systemic therapy such as azoles group and terbinafine is recommended for the standard
management of tinea capitis. In contrast, a prolonged course may be induce serious side
effects. So that topical therapy is the alternative treatment in older patients who are
limited in drug usage. Especially, non-dermatophyte onychomycosis is the recalcitrant
condition. Moreover, none of the standard regimen is recommended.
Nailprotex® is the novel topical treatment in onychomycosis and chronic paronychia. The
active ingredient is phenol which is extracted from Olea European leaf. It is able to
inhibit the fungal growth. Additionally, this product has been applied for nail care in many
European countries over 10 years. The serious side effects have never been reported.
Therefore, this study was designed to demonstrate the efficacy of this product in
non-dermatophyte (Scytalidium dimidiatum) onychomycosis and chronic paronychia treatment in
Thai patients.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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