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

NCT ID: NCT02464826

Last Updated: 2016-06-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2016-06-30

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.

Conditions

Onychomycosis; Chronic Paronychia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Edit arms

Nailprotex apply to the abnormal nail twice daily

Group Type: EXPERIMENTAL

Nailprotex

Intervention Type: DRUG

Nailprotex apply to the abnormal nail twice daily

Interventions

Nailprotex

Nailprotex apply to the abnormal nail twice daily

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mahidol University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Charussri - Leeyaphan, MD.

Role: PRINCIPAL_INVESTIGATOR

Department of Dermatology Faculty of Medicine, Siriraj Hospital Mahidol University

Locations

Department of Dermatology Siriraj Hospital

Bangkoknoi, Bangkok, Thailand

Countries

Thailand

Other Identifiers

Efficacynailprotex

Identifier Type: -

Identifier Source: org_study_id