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

Onychomycosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02464826
• Other study ID #: Efficacynailprotex
• Status: Completed
• Phase: Phase 4
• First received: April 30, 2015
• Last updated: June 16, 2016
• Start date: July 2015
• Est. completion date: June 2016

Study information

• Verified date: June 2016
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Paronychia
• Onychomycosis
• Paronychia

Intervention

Drug:
• Nailprotex
Nailprotex apply to the abnormal nail twice daily

Locations

Country	Name	City	State
Thailand	Department of Dermatology Siriraj Hospital	Bangkoknoi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change in the severity of onychomycosis by using SCIO (Scoring Clinical Index for Onychomycosis) score from baseline and 6 months-after using Nailprotex®	Patients who were treated by Nailprotex® in this study were evaluated the severity of onychomycosis by using SCIO (Scoring Clinical Index for Onychomycosis) score at baseline and after using Nailprotex® 6 months. Then the change in SCIO score was analyzed in percentage and compare mean.	6 months	Yes
Secondary	The side effects of Nailprotex®	The side effects of Nailprotex® was observed in patients from date of first application or first side effects documented progression until the date of end of study, assessed up to 6 months.	6 months	Yes
Secondary	Mycological cure rate which mean KOH and fungal culture result are both nagative after using Nailprotex® at 6 month after treated with Nailprotex®	Patients who were treated by Nailprotex® in this study were evaluated the results of laboratory investigation (KOH examination and fungal culture) at baseline and after using Nailprotex® 6 months. Then mycological cure rate was analyzed in percentage.	6 months	Yes