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

• ClinicalTrials.gov Identifier: NCT02705664
• Recruitment Status: Completed
• First Posted: March 10, 2016
• Last Update Posted: February 17, 2021
• Sponsor: Galderma R&D
• Information provided by (Responsible Party): Galderma R&D

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).

Condition or disease	Intervention/treatment	Phase
Foot Dermatoses	Drug: Loceryl Nail Lacquer; Drug: Urea Ointment; Drug: Bifonazole Cream	Phase 4

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)

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 22 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: January 2016
• Actual Primary Completion Date: September 2016
• Actual Study Completion Date: September 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: Loceryl NL; Amorolfine hydrochloride NL 5% to be applied once weekly for 7 weeks on all affected toenails of one foot	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; Other Name: Loceryl NL
Active Comparator: Urea Ointment + Bifonazole Cream; 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)	Drug: 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; Other Name: Urea; Drug: 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; Other Name: Bifonazole

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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,

Contacts and Locations

Locations

Iceland

Principal Investigator

Reykjavik, Iceland

Sponsors and Collaborators

Galderma R&D

Investigators

• Principal Investigator: Dr Sigurgeirsson; Cutis Ehf (Dermatology Center)

More Information

• Responsible Party: Galderma R&D
• ClinicalTrials.gov Identifier: NCT02705664
• Other Study ID Numbers: RD.03.SPR.105078
• First Posted: March 10, 2016
• Last Update Posted: February 17, 2021
• Last Verified: September 2016

Keywords provided by Galderma R&D:

Onychomycosis

Additional relevant MeSH terms:

Onychomycosis; Skin Diseases; Foot Dermatoses; Tinea; Dermatomycoses; Skin Diseases, Infectious; Infection; Mycoses; Nail Diseases; Foot Diseases; Amorolfine; Bifonazole; Antifungal Agents; Anti-Infective Agents