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.

Study Overview

• Status: Completed
• Conditions: Onychomycosis; Chronic Paronychia
• Intervention / Treatment: Drug: Nailprotex

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.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 4

Contacts and Locations

Study Locations

• Thailand
  • Bangkok
    • Bangkoknoi, Bangkok, Thailand, 10700
      • Department of Dermatology Siriraj Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Edit arms; Nailprotex apply to the abnormal nail twice daily	Drug: Nailprotex; Nailprotex apply to the abnormal nail twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Mahidol University
• Investigators: Principal Investigator: Charussri - Leeyaphan, MD., Department of Dermatology Faculty of Medicine, Siriraj Hospital Mahidol University

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: April 30, 2015
• First Submitted That Met QC Criteria: June 3, 2015
• First Posted (Estimate): June 8, 2015

Study Record Updates

• Last Update Posted (Estimate): June 17, 2016
• Last Update Submitted That Met QC Criteria: June 16, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: Treatment; Onychomycosis; Chronic paronychia
• Additional Relevant MeSH Terms: Skin Diseases; Infections; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Mycoses; Tinea; Dermatomycoses; Nail Diseases; Onychomycosis; Paronychia
• Other Study ID Numbers: Efficacynailprotex