NCT02464826

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jul 2015

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 8, 2015

Completed
23 days until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

June 17, 2016

Status Verified

June 1, 2016

Enrollment Period

11 months

First QC Date

April 30, 2015

Last Update Submit

June 16, 2016

Conditions

OnychomycosisChronic Paronychia

Keywords

OnychomycosisChronic paronychiaTreatment

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • The side effects of Nailprotex®

    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®

    6 months

Study Arms (1)

Edit arms

EXPERIMENTAL

Nailprotex apply to the abnormal nail twice daily

Drug: Nailprotex

Interventions

NailprotexDRUG

Nailprotex apply to the abnormal nail twice daily

Edit arms

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Dermatology Siriraj Hospital

Bangkoknoi, Bangkok, 10700, Thailand

Location

MeSH Terms

Conditions

Onychomycosis

Condition Hierarchy (Ancestors)

TineaDermatomycosesMycosesBacterial Infections and MycosesInfectionsSkin Diseases, InfectiousNail DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Charussri - Leeyaphan, MD.

    Department of Dermatology Faculty of Medicine, Siriraj Hospital Mahidol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2015

First Posted

June 8, 2015

Study Start

July 1, 2015

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

June 17, 2016

Record last verified: 2016-06

Locations

TH(1)