NCT02812043

Brief Summary

This study aims to compare the efficacy and safety of amorolfine, long-pulsed Nd:YAG laser and the combination between amorolfine and long-pulsed Nd:YAG in treating the non-dermatophyte and mixed-infection onychomycosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2016

Typical duration 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 13, 2015

Completed
8 months until next milestone

First Posted

Study publicly available on registry

June 23, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

September 28, 2021

Status Verified

September 1, 2021

Enrollment Period

2.8 years

First QC Date

October 13, 2015

Last Update Submit

September 24, 2021

Conditions

Non-dermatophyte Onychomycosis

Keywords

onychomycosisamorolfinelong-pulsed Nd:YAGfungal infection

Outcome Measures

Primary Outcomes (1)

  • Mycological cure rate in patients with onychomycosis after Amorolfine, long-pulsed Nd:YAG and the adjunct treatment

    Mycological cure defined as negative Mycological culture

    6 months after treatment

Secondary Outcomes (15)

  • Mycological cure rate in patients with onychomycosis after Amorolfine, long-pulsed Nd:YAG and the adjunct treatment

    1 month after treatment

  • Mycological cure rate in patients with onychomycosis after Amorolfine, long-pulsed Nd:YAG and the adjunct treatment

    2 months after treatment

  • Mycological cure rate in patients with onychomycosis after Amorolfine, long-pulsed Nd:YAG and the adjunct treatment

    3 months after treatment

  • number of participants who develop paronychia after Amorolfine, long-pulsed Nd:YAG and the adjunct treatment

    1 month after treatment

  • number of participants who develop paronychia after Amorolfine, long-pulsed Nd:YAG and the adjunct treatment

    2 months after treatment

  • +10 more secondary outcomes

Study Arms (3)

Amorolfine

EXPERIMENTAL

This group of patients will receive only amorolfine nail lacquer to apply on the affected nail and the KOH examination and fungal culture will be performed every month

Drug: Amorolfine

Long-pulsed Nd:YAG

EXPERIMENTAL

This group of patients will receive only the long-pulsed Nd:YAG (Cynergy®, 5 Carlisle Road Westford, MA USA) fluence 35-45 J/Cm2, spot size 4mm for 2 passes each visit with 4-week intervals and the KOH examination and fungal culture will be performed every month

Device: 1,064nm Long-pulsed Nd:YAG

Amorolfine+Long-pulsed Nd:YAG

EXPERIMENTAL

This group of patients will receive both amorolfine nail lacquer and the long-pulsed Nd:YAG laser treatment each visit with 4-week intervals and the KOH examination and fungal culture will be performed every month

Device: 1,064nm Long-pulsed Nd:YAGDrug: Amorolfine

Interventions

1,064nm Long-pulsed Nd:YAGDEVICE

Long-pulsed 1,064nm will be used for the treatment of onychomycosis which wll use 35-45 J/cm2 spot size 4, frequency 1 Hz for 2 passes on the infected nails

Also known as: Dualis SP; Fotona, Lujbljana
Amorolfine+Long-pulsed Nd:YAGLong-pulsed Nd:YAG
AmorolfineDRUG

Amorolfine nail lacquer will be applied by the patient once a week on the infected nails

AmorolfineAmorolfine+Long-pulsed Nd:YAG

Eligibility Criteria

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

You may qualify if:

  • The patients aged more than 18 years old.
  • The patients were diagnosed with non-dermatophytes or mixed-infection onychomycosis from both KOH examination and fungal cultured.
  • The patients did not have any prior anti-fungal treatment within 6 months
  • The patients did not receive any vasodilator drugs or isotretinoin within 6 months
  • The patients who are willing to participate, and accept the methods and risk

You may not qualify if:

  • The patients who suffered other medical dermatologic condition associated with onychomycosis such as psoriasis, paronychia etc.
  • The patients who took immunosuppressive drugs, or the immunocompromised host.
  • The patients who had severe vascular disease, such as severe DVT, or poor capillary refill time.
  • The patients who had onychomycosis which involved in nail matrix.
  • Pregnancy or lactation.
  • The patients who had problems communication or have difficulty travel to the faculty for the checkup.

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

OnychomycosisMycoses

Interventions

amorolfine

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2015

First Posted

June 23, 2016

Study Start

August 1, 2016

Primary Completion

June 1, 2019

Study Completion

December 1, 2019

Last Updated

September 28, 2021

Record last verified: 2021-09

Locations

TH(1)