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OpenTrials
Completed

NCT Number: NCT02705664

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

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).

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Key information

Conditions

Foot Dermatoses Bacterial Infections and Mycoses Dermatomycoses Foot Diseases Infections Mycoses Nail Diseases Onychomycosis Skin Diseases Skin Diseases, Infectious Skin and Connective Tissue Diseases Tinea

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Principal Investigator

Reykjavik, Iceland

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

Loceryl Nail Lacquer

Drug

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

Other names: Loceryl NL

Urea Ointment

Drug

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

Other names: Urea

Bifonazole Cream

Drug

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

Other names: Bifonazole

Primary outcomes

  1. % adherent subjects with applications

    Time frame: Week 7

    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)

  2. % adherent subjects with nail preparation

    Time frame: Week 7

    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

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

    Time frame: Week 7

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

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study 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%

Acronym: OPEN

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Mar 10, 2016
Registry last updated
Feb 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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