Determination of antifungal activity of Loceryl® Nail Lacquer 5% when used concomitantly with a cosmetic nail varnish compared to a Loceryl® Nail Lacquer 5% alone in treatment of toenail Distal Subungual Onychomycosis

Conditions: Mild to moderate toenail Distal Subungual Onychomycosis
MedDRA version: 14.1Level: PTClassification code 10030338Term: OnychomycosisSystem Organ Class: 10021881 - Infections and infestations
Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Registration Number: EUCTR2013-000544-26-IS

Lead Sponsor: Galderma R&D

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 50

Inclusion Criteria

In general, the investigator will ensure to enroll Subjects with heterogeneous disease characteristics regarding affected toenails in the limits defined below.
In order to be eligible for the study, subjects must fulfill all of the following criteria.

1. Male or female subjects 18 years of age or older,
2. Subjects with a mild to moderate Distal Subungual Onychomycosis (DSO) on at least 1 great toenail without matrix involvement. One great toenail or the most affected toenail will be chosen as a Target nail,
3. Subjects must have maximum of 50% of nail distal edge involved and no dermatophytoma or subungual hyperkeratosis > 2mm,
4. Subjects with positive mycological results (direct microscopy and culture) of the Target nail for dermatophytes or Yeast (including Candida) at Screening,
5. Females of childbearing potential with a negative urine pregnancy test (UPT) at Screening and Baseline and must practice a highly 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,
6. Females of non-childbearing potential, i.e., premenses, post-menopausal (absence of menstrual bleeding for 1 year), hysterectomy, or bilateral oophorectomy, are not required to have a UPT at Screening and Baseline visits,
7. Subject must understand, sign and receive a copy of an informed consent at Screening prior to any investigational procedure being performed.
8. Subjects must be willing and capable of cooperating to the extent and degree required by the protocol (including refraining from the use of other 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 45
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

Any subject who is meeting one or more of the following criteria will not be included in this study.
1. Subjects with clinically important abnormal physical findings at the Screening/Baseline visit, which would interfere with the objectives of the study,
2. Lichen planus, eczema, psoriasis, or other abnormalities of the nail unit, which could result in an abnormal appearing nail despite clearing of Onychomycosis,
3. Known immunodeficiencies, radiation therapy, immune suppressive drugs,
4. Pregnancy, nursing (lactating) females, or females planning a pregnancy during the study,
5. Subjects who have not undergone the specified washout period(s) for the following preparations:
• Topical nail antifungal therapy, cream and solution 1 Month
• Topical nail antifungal therapy, lacquers 3 Months
• Systemic Itraconazole 6 Months
• Systemic Terbinafine 6 Months
• Systemic Griseofulvin 6 Months
• Systemic Fluconazole 6 Months
6. Subjects who will need to use any product other than the investigational products on the toenails during the study,
7. Subjects with known sensitivities to any of the study preparations (see Summary of Product Characteristics - SmPC),
8. Subjects participating in a clinical research study within the last 30 days prior to enrollment.
9. Subject under guardianship, hospitalized subjects in a public or private institution for a reason other than the research, and subjects deprived of his/her freedom.