A Pilot Study - Safety and Efficacy of Nailprotex® for Onychomycosis Treatment

Mahidol University

Status and phase

Completed

Phase 4

Conditions

Chronic Paronychia

Onychomycosis

Treatments

Drug: Nailprotex

Study type

Interventional

Funder types

Other

Identifiers

NCT02464826

Efficacynailprotex

Details and patient eligibility

About

This study was designed to demonstrate the efficacy of this product in non-dermatophyte (Scytalidium dimidiatum) onychomycosis and chronic paronychia treatment in Thai patients.

Full description

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.

Enrollment

19 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Male or female participants was 18 years old or above.
Participants were diagnosed Scytalidium dimidiatum onychomycosis or chronic paronychia by dermatologists based on clinical presentation and mycological identification.
Participants accept the aim of this project and sign the consent form by themselves.

Exclusion criteria

Participants have other nail disorders before participate the research.
Participants have the history of immunocompromised host.
Participants were diagnosed onychomycosis more than 3 nails or matrix involvement.