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

Foot Dermatoses Clinical Trial

— 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%

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02705664
• Other study ID #: RD.03.SPR.105078
• Status: Completed
• Phase: Phase 4
• Start date: January 2016
• Est. completion date: September 2016

Study information

• Verified date: September 2016
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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,

Related Conditions & MeSH terms

• Foot Dermatoses
• Onychomycosis
• Skin Diseases

Intervention

Drug:
• Loceryl Nail Lacquer
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
• Urea Ointment
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
• Bifonazole Cream
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

Locations

Country	Name	City	State
Iceland	Principal Investigator	Reykjavik

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Country where clinical trial is conducted

Iceland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% 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)	Week 7
Primary	% 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	Week 7
Primary	% 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	Week 7