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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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%

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 Summary:

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)

Sponsor: Galderma

Current Primary Outcome:

  • % 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)
  • % 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
  • % 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Galderma

Dates:
Date Received: March 7, 2016
Date Started: January 2016
Date Completion:
Last Updated: September 15, 2016
Last Verified: September 2016