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

• Register: EUCTR
• Last refreshed on: 11 April 2016
• Main ID: EUCTR2013-000544-26-IS
• Date of registration: 29/10/2013
• Prospective Registration: Yes
• Primary sponsor: Galderma R&D
• Public title: 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
• Scientific title: 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 - COOL
• Date of first enrolment: 10/12/2013
• Target sample size: 50
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-000544-26
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: yes Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: Loceryl® Nail Lacquer + cosmetic varnish Number of treatment arms in the trial: 2

Countries of recruitment

Iceland

Contacts

• Name: Clinical Project manager
• Affiliation: Galderma R&D

• Name: Clinical Project manager
• Affiliation: Galderma R&D

Key inclusion & exclusion criteria

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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Mild to moderate toenail Distal Subungual Onychomycosis
MedDRA version: 14.1 Level: PT Classification code 10030338 Term: Onychomycosis System Organ Class: 10021881 - Infections and infestations

Intervention(s)

Trade Name: Loceryl Nail Lacquer
Product Name: Loceryl
Pharmaceutical Form: Medicated nail lacquer
INN or Proposed INN: AMOROLFINE HYDROCHLORIDE
CAS Number: [78613-38-4]
Concentration unit: % (W/V) percent weight/volume
Concentration type: equal
Concentration number: 5-

Trade Name: MAYBELLINE Cosmetic nail varnish AND Loceryl nail lacquer
Product Name: MAYBELLINE and Loceryl Nail Lacquer
Pharmaceutical Form: Medicated nail lacquer
INN or Proposed INN: AMOROLFINE HYDROCHLORIDE
CAS Number: [78613-38-4]
Concentration unit: % (W/V) percent weight/volume
Concentration type: equal
Concentration number: 5-

Primary Outcome(s)

Main Objective: The main objective is to compare the efficacy, in terms of antifungal activity of Loceryl® Nail Lacquer (amorolfine) associated with a Cosmetic Varnish and Loceryl® Nail Lacquer alone, in the treatment of mild to moderate toenail Distal Subungual Onychomycosis

Primary end point(s): Based on previous results, the clinical hypothesis is that the antifungal activity of Loceryl® Nail Lacquer is unaffected when used once weekly in combination with cosmetic varnish on the affected toenails.

Secondary Objective: Subject safety and satisfaction

Timepoint(s) of evaluation of this end point: In week 12 visit (end of study) or early termination.

Secondary Outcome(s)

Secondary end point(s): In addition, the cosmetic varnish will improve subjects’ life by hiding the diseased aspect of the toenails from the beginning of treatment. This study has been designed to provide evidence in support of this hypothesis.

Timepoint(s) of evaluation of this end point: In week 12 visit (end of study) or early termination.

Secondary ID(s)

RD.03.SPR.29106

Source(s) of Monetary Support

Galderma R&D