Toenail Distal and Lateral Subungual Onychomycosis MedDRA version: 18.0 Level: PT Classification code 10030338 Term: Onychomycosis System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Loceryl® Nail Lacquer
Product Name: Loceryl® Nail Lacquer
Pharmaceutical Form: Medicated nail lacquer
INN or Proposed INN: AMOROLFINE HYDROCHLORIDE
CAS Number: 78613-38-4
Concentration uni
Sponsors
Galderma R&D
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: INCLUSION CRITERIA In general, the investigator will enrol subjects with heterogeneous disease characteristics regarding affected toenails within the limits defined below. 1. Male or female subjects aged 18 years or older, 2. Subject with clinically Distal and Lateral Subungual Onychomycosis (DLSO) due to dermatophytes and/or yeast (including Candida) on at least one toenail of each foot at screening visit, 3. Subject with less than 80% of the nail surface area with disease involvement and without matrix involvement, no dermatophytoma, streaks (spikes) or subungual hyperkeratosis > 2mm, 4. 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, 5. Subjects with positive mycological results (direct microscopy and culture) for dermatophytes and/or yeasts (including Candida) at baseline. The exams will be performed by the Mycological Laboratory as usual in routine practice, 6. Females of childbearing potential with a negative urine pregnancy test (UPT) at Screening and Baseline must use an effective method of contraception during the study: oral/systemic (injectable, patch, etc. contraception must have been on a stable dose for 3 months prior to study entry), bilateral Tubal Ligation, hormonal Intra-Uterine Device IUD (inserted at least 1 month prior to screening), strict abstinence,or partner had a vasectomy, 7. Females of non-childbearing potential, defined as post-menopausal (absence of menstrual bleeding for 1 year), hysterectomy, or bilateral oophorectomy, 8. Subjects must understand, sign and receive a copy of an informed consent at Screening prior to any investigational procedure being performed, 9. Subjects must be able and willing to cooperate to the extent and degree required by the protocol (including refraining from using cosmetic nail products on the affected toenails during the study). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: EXCLUSION CRITERIA Any subject who meets one or more of the following criteria will not be included in the study. 1. The subject with a surgical, medical condition or clinically important abnormal physical findings which, in the judgement of the investigator, might interfere with interpretation of the objectives of the study (i.e. lack of autonomy), 2. Post-traumatic nail, lichen planus, eczema, psoriasis, or other abnormalities of the nail unit, which could affect/influence the subject’s compliance of the investigational products, or mask the effects of treatment (cure), 3. Known immunodeficiency, radiation therapy, immune suppressive drugs, 4. Pregnancy, nursing (lactating) females, or females planning a pregnancy during the study, 5. Subjects needing to use any procedure or product (i.e. topical nail treatment, care or cosmetic lacquer) other than the investigational products on the toenails or surrounding skin during the study, 6. Any other treatments which at the investigator’s judgment are liable to interfere or interact with the safety of study evaluation, 7. Subjects with known sensitivity to any of the study preparations (see Summary of Products Characteristics - SmPC), 8. Subjects participating in a clinical research study within the last 30 days prior to enrollment, 9. Subjects under guardianship, hospitalized subjects in a public or private institution for a reason other than the research, and subjects deprived of his/her freedom.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this study is to compare subject-reported adherence and satisfaction for two modes of treatment of Distal and Lateral Subungual Onychomycosis (DLSO) with Loceryl® Nail Lacquer (Amorolfine) and Ciclopoli® Nail Lacquer (Ciclopirox) in toenails.;Secondary Objective: Subject safety and satisfaction;Primary end point(s): Based on previous results, the clinical hypothesis is that subject’s adherence with the recommended regimen depends not only on the efficacy and safety of treatments but also on the ease of use of the treatments and application procedures;Timepoint(s) of evaluation of this end point: up to week 12 visit (end of study) or early termination | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Effective duration of nail exposure after the application of either antifungal is longer than the recommended time to next application. Therefore, both the subjects’ adherence to the regimen recommended by the respective labels and the evaluation of effective nail exposure will be assessed using a subject Diary, direct questioning of subjects regarding their preference for one of the study products and via a questionnaire. This study has been designed to provide evidence in support of this hypothesis.;Timepoint(s) of evaluation of this end point: up to week 12 visit (end of study) or early termination | — |
Countries
Germany
Contacts
Public ContactFarzaneh Sidou
Galderma R&D
Outcome results
None listed