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Treatment of Onychomycosis With Loceryl (Amorolfine) Nail Lacquer 5% Versus a Two-course Treatment With Urea 40% Ointment and Bifonazole Cream 1% (OPEN)

Primary Purpose

Foot Dermatoses

Status

Completed

Phase

Phase 4

Locations

Iceland

Study Type

Interventional

Intervention

Loceryl Nail Lacquer

Urea Ointment

Bifonazole Cream

About this trial

This is an interventional treatment trial for Foot Dermatoses focused on measuring Onychomycosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subjects with clinically Distal and Lateral Subungual Onychomycosis (DLSO) due to dermatophytes and/or yeast (including Candida) on at least one great toenail of each foot at screening visit,
Subjects with less than 50% of the toenail surface area from the Distal edge with disease involvement and without matrix involvement, no dermatophytoma, streaks (spikes) or subungual hyperkeratosis > 2mm,
Subjects should have the same number of affected toenails on both feet or no more than one additional affected toenail on one of the feet,
Subjects with positive mycological results (direct microscopy and culture) of the most affected toenail (or great toenail) for dermatophytes or yeast (including Candida) at Baseline

Exclusion Criteria:

Subjects with matrix involvement on the great toenails,
Subjects with a surgical, medical condition or clinically important abnormal physical findings which might interfere with the interpretation of the objectives of the study
Post-traumatic toenail, lichen planus, eczema, psoriasis, or other abnormalities of the nail unit, which could affect/influence the subject's compliance with the investigational products or mask the effects of treatment (cure),
Known immunodeficiency, radiation therapy, immune suppressive drugs,

Sites / Locations

Principal Investigator

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Loceryl NL

Urea Ointment + Bifonazole Cream

Arm Description

Amorolfine hydrochloride NL 5% to be applied once weekly for 7 weeks on all affected toenails of one foot

On the opposite foot: Urea 40% ointment to be applied once a day under occlusion for 2-3 weeks depending on the achievement of optimal diseased toenail plates removal) Bifonazole 1% cream to be applied for 4 weeks on affected toenails (after the maximum 3-week treatment period with Urea ointment)

Outcomes

Primary Outcome Measures

% adherent subjects with applications

Percent of subjects having applied both study treatments as instructed (once a week for Loceryl NL, once a day for urea and once a day for Bifonazole)

% adherent subjects with nail preparation

Percent of subjects having prepared affected toenails as instructed for each product before applications: For Loceryl: File down the affected toenails as required and clean toenails surface with the cleansing swab For Urea: Soak toenails in warm water and remove soften infected toenails plates For Bifonazole: Clean and dry thoroughly affected toenails

% Subjects satisfied to very satisfied with each study treatment at week 7

Percent of subjects satisfied to very satisfied with each study treatment at week 7

Secondary Outcome Measures

Full Information

NCT ID

NCT02705664

First Posted

March 7, 2016

Last Updated

February 16, 2021

Sponsor

Galderma R&D

1. Study Identification

Unique Protocol Identification Number

NCT02705664

Brief Title

Treatment of Onychomycosis With Loceryl (Amorolfine) Nail Lacquer 5% Versus a Two-course Treatment With Urea 40% Ointment and Bifonazole Cream 1%

Acronym

OPEN

Official Title

Subject Adherence and Satisfaction for Treatment of Onychomycosis With Loceryl Nail Lacquer 5% Versus a Fungal Nail Treatment Set Containing Urea 40% Ointment and Bifonazole Cream 1%

Study Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Completed

Study Start Date

January 2016 (undefined)

Primary Completion Date

September 2016 (Actual)

Study Completion Date

September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Galderma R&D

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The main objective of this study is to compare subject adherence and satisfaction for two modes of treatment toenails infection (Onychomycosis) with Loceryl Nail Lacquer (Loceryl NL) and a Fungal Nail Treatment Set containing Urea 40% ointment (Urea) and Bifonazole cream 1% (Bifonazole).

Detailed Description

A total of 20 subjects are to be included in 1 site in Iceland Methodology: Subjects will receive following treatments on the right or left toenails: Loceryl Nail Lacquer (Loceryl NL) to be applied once weekly for 7 weeks on all affected toenails of one foot (including great toenail) Fungal Nail Treatment Set to be used on all affected toenails (including great toenail) of the opposite foot in two phases: Phase I: Urea ointment (Urea) to be applied once a day under occlusion for 2-3 weeks depending on the achievement of optimal diseased toenail plates removal Phase II: Bifonazole cream to (Bifonazole) be applied for 4 weeks on affected toenails (after the maximum 3-week treatment period with Urea ointment)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Foot Dermatoses

Keywords

Onychomycosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

22 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Loceryl NL

Arm Type

Experimental

Arm Description

Amorolfine hydrochloride NL 5% to be applied once weekly for 7 weeks on all affected toenails of one foot

Arm Title

Urea Ointment + Bifonazole Cream

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Loceryl Nail Lacquer

Other Intervention Name(s)

Loceryl NL

Intervention Description

Topical over entire toenail plates of affected toenails once weekly in the evening (at bed time) after having filled down affected toenails to gently remove as much as affected nails and having cleaned toenails surfaces with the provided cleansing swab

Intervention Type

Drug

Intervention Name(s)

Urea Ointment

Other Intervention Name(s)

Urea

Intervention Description

Topical over the infected part of the toenails only once daily under occlusion in the evening (at bed time) after having soaked toenails in warm water and having removed the soften infected toenail plates and dried the toenails

Intervention Type

Drug

Intervention Name(s)

Bifonazole Cream

Other Intervention Name(s)

Bifonazole

Intervention Description

Topical, to be rubbed sparingly over the affected toenail skin (nail bed) once daily in the evening (at bed time) after having cleaned and dried thoroughly toenails

Primary Outcome Measure Information:

Title

% adherent subjects with applications

Description

Percent of subjects having applied both study treatments as instructed (once a week for Loceryl NL, once a day for urea and once a day for Bifonazole)

Time Frame

Week 7

Title

% adherent subjects with nail preparation

Description

Time Frame

Week 7

Title

% Subjects satisfied to very satisfied with each study treatment at week 7

Description

Percent of subjects satisfied to very satisfied with each study treatment at week 7

Time Frame

Week 7

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects with clinically Distal and Lateral Subungual Onychomycosis (DLSO) due to dermatophytes and/or yeast (including Candida) on at least one great toenail of each foot at screening visit, Subjects with less than 50% of the toenail surface area from the Distal edge with disease involvement and without matrix involvement, no dermatophytoma, streaks (spikes) or subungual hyperkeratosis > 2mm, Subjects should have the same number of affected toenails on both feet or no more than one additional affected toenail on one of the feet, Subjects with positive mycological results (direct microscopy and culture) of the most affected toenail (or great toenail) for dermatophytes or yeast (including Candida) at Baseline Exclusion Criteria: Subjects with matrix involvement on the great toenails, Subjects with a surgical, medical condition or clinically important abnormal physical findings which might interfere with the interpretation of the objectives of the study Post-traumatic toenail, lichen planus, eczema, psoriasis, or other abnormalities of the nail unit, which could affect/influence the subject's compliance with the investigational products or mask the effects of treatment (cure), Known immunodeficiency, radiation therapy, immune suppressive drugs,

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dr Sigurgeirsson

Organizational Affiliation

Cutis Ehf (Dermatology Center)

Official's Role

Principal Investigator

Facility Information:

Facility Name

Principal Investigator

City

Reykjavik

Country

Iceland

12. IPD Sharing Statement

Learn more about this trial

Treatment of Onychomycosis With Loceryl (Amorolfine) Nail Lacquer 5% Versus a Two-course Treatment With Urea 40% Ointment and Bifonazole Cream 1%

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