Clinical trial NCT02464826: A Pilot Study - Safety and Efficacy of Nailprotex® for Onychomycosis Treatment
Official title: A Pilot Study - Safety and Efficacy of Nailprotex® for Onychomycosis Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Onychomycosis
Chronic Paronychia
Keywords: Onychomycosis
Chronic paronychia
Treatment
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2015-06-08
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The change in the severity of onychomycosis by using SCIO (Scoring Clinical Index for Onychomycosis) score from baseline and 6 months-after using Nailprotex®
timeFrame: 6 months
Secondary outcomes:
measure: The side effects of Nailprotex®
timeFrame: 6 months
measure: Mycological cure rate which mean KOH and fungal culture result are both nagative after using Nailprotex® at 6 month after treated with Nailprotex®
timeFrame: 6 months
Other outcomes:
Locations:
city: Bangkoknoi
country: Thailand
facility: Department of Dermatology Siriraj Hospital
state: Bangkok
Study officials:
affiliation: Department of Dermatology Faculty of Medicine, Siriraj Hospital Mahidol University
name: Charussri - Leeyaphan, MD.
role: PRINCIPAL_INVESTIGATOR
References: