NCT01851590

Brief Summary

The current study is conducted to corroborate the previous observational clinical trial with more valid methods and a more clinically relevant experimental design. This study aims to compare efficacy, safety, and cost between topically administered 30% resin lacquer for the treatment of dermatophyte toenail onychomycosis and the current "best practices": topical 5% amorolfine and systemic terbinafine.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
129

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2013

Shorter than P25 for phase_4

Geographic Reach
1 country

2 active sites

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

May 8, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 10, 2013

Completed
5 months until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

November 30, 2015

Completed
Last Updated

November 30, 2015

Status Verified

October 1, 2015

Enrollment Period

1 year

First QC Date

May 8, 2013

Results QC Date

March 20, 2015

Last Update Submit

October 24, 2015

Conditions

Onychomycosis

Keywords

Dermatophyte onychomycosisFungal nail infectionResin LacquerAmorolfineTerbinafine

Outcome Measures

Primary Outcomes (1)

  • Mycological Cure

    To analyze the rate of complete mycological cure i.e. fungal eradication in terms of negative mycological culture AND negative potassium hydroxide (KOH) stain at 4- and 10 months time-points from the beginning of the study.

    At 4- and 10 months time-points from the beginning of the study.

Secondary Outcomes (4)

  • Clinical Responses to the Treatments

    At 4- and 10 months time-points from the beginning of the study.

  • Cost-effectiveness 1

    At 10-month time-point

  • Cost-effectiveness 2

    At 10-month time-point

  • Compliance to the Treatment

    At 4-month time-point

Study Arms (3)

Resin Lacquer

EXPERIMENTAL

Topical 30% Resin Lacquer applied once daily for 9 months (Abicin® 30% Nail Lacquer).

Device: Resin Lacquer

Amorolfine

ACTIVE COMPARATOR

Topical 5% Amorolfine Lacquer applied once weekly for 9 months (Loceryl® 5% Nail Lacquer).

Drug: Amorolfine

Terbinafine

ACTIVE COMPARATOR

250 mg of Terbinafine taken orally once daily for 3 months (Generics).

Drug: Terbinafine

Interventions

Resin LacquerDEVICE

30% Resin Lacquer is applied once daily for 9 months (Abicin®) in toenail onychomycosis.

Also known as: Resin Lacquer arm
Resin Lacquer
AmorolfineDRUG

5% Amorolfine Lacquer is applied once weekly for 9 months (Loceryl®) in toenail onychomycosis.

Also known as: Amorolfine Lacquer arm
Amorolfine
TerbinafineDRUG

250 mg of Terbinafine is taken orally once daily for 3 months (Generics) in toenail onychomycosis.

Also known as: Terbinafine arm
Terbinafine

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Positive dermatophyte culture in the beginning of the study obtained from the toenail sample.
  • Positive KOH stain in the beginning of the study obtained from the toenail sample.

You may not qualify if:

  • Any other nail disease than dermatophyte culture or KOH stain verified onychomycosis
  • Onychomycosis caused by yeasts or nondermatophyte molds
  • Kidney failure determined by plasma creatinine level (P-Krea \> 100 μmol/l)
  • Liver failure determined by plasma γ-glutamyltransferase level (P-GT \> 120 U/I)
  • Sensitivity or allergy to Resin, Amorolfine or Terbinafine
  • Potential adverse cross-reaction of Terbinafine, Amorolfine or Resin with the patient's permanent medication
  • Presence of total dystrophic onychomycosis (TDO)
  • Any topical or oral antifungal treatment within the 6 months before the beginning of the study (washout period \> 6 months).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Vääksyn Lääkärikeskus

Vääksy, Vääksy, FI-17200, Finland

Location

Vääksyn Lääkärikeskus

Vääksy, FI-17200, Finland

Location

Related Publications (1)

  • Sigurgeirsson B et al. Efficacy of amorfine nail lacquer for the prophylaxis of onychomycosis over 3 years. J Eur Acad Dermatol Venereol 2010;24: 910-5. Rautio M et al. Antibacterial effects of home-made resin salve from Norway spruce (Picea abies). APMIS 2007;115: 335-340. Rautio M et al. In vitro fungistatic effects of natural coniferous rosin from Norway spruce (Picea abies). Eur J Clin Microbiol Infect Dis 2012;31:1783-9. Sipponen A et al. Effects of Norway spruce (Picea abies) resin on cell wall and cell membrane of Staphylococcus aureus. Ultrastruct Pathol 2009;33: 128-135. Sipponen P et al. Natural coniferous resin lacquer in treatment of toenail onychomycosis: an observational study. Mycoses 2012, Accepted. Roberts DT et al. British Association of Dermatologists. Guidelines for treatment of onychomycosis. Br J Dermatol 2003;148:402-10. Baran R et al. A new classification of onychomycosis. Br J Dermatol 1998;139: 567-71.

    BACKGROUND

MeSH Terms

Conditions

Onychomycosis

Interventions

amorolfineTerbinafine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

NaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Limitations and Caveats

* Relatively short treatment period for the toenail onychomycosis (9 months). * Patients with total dystrophic onychomycosis (46%) - the most difficult subtype to treat - may not have been amenable to monotherapy with a topical antifungal treatment.

Results Point of Contact

Title
Janne Jokinen, MD, PhD, Consultant Cardiothoracic Surgeon
Organization
Department of Cardiac Surgery, Heart and Lung Centre, Helsinki University Hospital, Finland
janne.jokinen@helsinki.fi
50 554 8103

Study Officials

  • Janne J. Jokinen, MD, PhD

    Department of Cardiac Surgery, Heart and Lung Centre, Helsinki University Hospital, FI-00029, Helsinki, Finland

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Cardiothoracic Surgeon

Study Record Dates

First Submitted

May 8, 2013

First Posted

May 10, 2013

Study Start

October 1, 2013

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

November 30, 2015

Results First Posted

November 30, 2015

Record last verified: 2015-10

Locations

FI(2)