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

• Register: ClinicalTrials.gov
• Last refreshed on: 1 March 2021
• Main ID: NCT02705664
• Date of registration: 07/03/2016
• Prospective Registration: No
• Primary sponsor: Galderma R&D
• Public title: Treatment of Onychomycosis With Loceryl (Amorolfine) Nail Lacquer 5% Versus a Two-course Treatment With Urea 40% Ointment and Bifonazole Cream 1% OPEN
• Scientific 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%
• Date of first enrolment: January 2016
• Target sample size: 22
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02705664
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Iceland

Contacts

• Name: Dr Sigurgeirsson
• Affiliation: Cutis Ehf (Dermatology Center)

Key inclusion & exclusion 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,



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Foot Dermatoses

Intervention(s)

Drug: Loceryl Nail Lacquer

Drug: Bifonazole Cream

Drug: Urea Ointment

Primary Outcome(s)

% adherent subjects with applications [Time Frame: Week 7]

% adherent subjects with nail preparation [Time Frame: Week 7]

% Subjects satisfied to very satisfied with each study treatment at week 7 [Time Frame: Week 7]

Secondary ID(s)

RD.03.SPR.105078

Source(s) of Monetary Support

Please refer to primary and secondary sponsors