Clinical trial NCT02705664: Treatment of Onychomycosis With Loceryl (Amorolfine) Nail Lacquer 5% Versus a Two-course Treatment With Urea 40% Ointment and Bifonazole Cream 1%
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Foot Dermatoses
Keywords: Onychomycosis
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2016-03-10
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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)

Eligibility 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,

Primary outcomes:
measure: % adherent subjects with applications
timeFrame: Week 7
measure: % adherent subjects with nail preparation
timeFrame: Week 7
measure: % Subjects satisfied to very satisfied with each study treatment at week 7
timeFrame: Week 7
Secondary outcomes:
Other outcomes:
Locations:
city: Reykjavik
country: Iceland
facility: Principal Investigator
Study officials:
affiliation: Cutis Ehf (Dermatology Center)
name: Dr Sigurgeirsson
role: PRINCIPAL_INVESTIGATOR
References: