Subject adherence and satisfaction for treatment of Onychomycosis with Loceryl® Nail Lacquer 5% versus Canesten® Fungal Nail Treatment Set

• Register: EUCTR
• Last refreshed on: 5 June 2017
• Main ID: EUCTR2015-001503-31-IS
• Date of registration: 30/10/2015
• Prospective Registration: Yes
• Primary sponsor: Galderma R&D
• Public title: Subject adherence and satisfaction for treatment of Onychomycosis with Loceryl® Nail Lacquer 5% versus Canesten® Fungal Nail Treatment Set
• Scientific title: Subject adherence and satisfaction for treatment of Onychomycosis with Loceryl® Nail Lacquer 5% versus Canesten® Fungal Nail Treatment Set - OPEN
• Date of first enrolment: 30/11/2015
• Target sample size: 20
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-001503-31
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: yes Other trial design description: intra-individual If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: yes Other specify the comparator: Loceryl® Nail Lacquer + Canesten® Fungal Nail Treatment Set (Urea 40% / Bifonazole 1%) Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

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 homogenous disease characteristics regarding affected toenails within the limits defined below:
1. Male or female subjects aged 18 years or older,
2. 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,
3. 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,
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) of the most affected toenail (or great toenail) for dermatophytes or yeast (including Candida) at Baseline. The exams will be performed by the Mycological Laboratory as usual in routine practice (see attachment 1),
6. Females of childbearing potential with a negative Urine Pregnancy Test (UPT) at Screening and Baseline visits must use 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,
7. Females of non-childbearing potential, 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 visit 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 or other nail products on the affected toenails during the study).
Rationale:
1-4: In order to select a suitable population for the clinical trial,
5: To include only subjects with confirmed onychomycosis,
6-7: Due to limited amount of data on human pregnancy,
8: Only subjects who provided written consent are allowed to participate in this clinical trial,
9: In order to ensure compliance to the clinical trial.

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:
Any subject who meets one or more of the following criteria will not be included in the study:
1. Subjects with matrix involvement on the great toenails,
2. Subjects with a surgical, medical condition or clinically important abnormal physical findings which, in the judgment of the investigator, might interfere with the interpretation of the objectives of the study (i.e. lack of autonomy),
3. 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),
4. Known immunodeficiency, radiation therapy, immune suppressive drugs,
5. Pregnancy, nursing (lactating) females, or females planning a pregnancy during the study,
6. 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,
7. Any other treatments, which at the investigator’s judgment are liable to interfere or interact with the safety of study evaluation,
8. Subjects with known sensitivity to any of the study preparations (see Summary of Products Characteristics - SmPC),
9. Subjects participating in a clinical research study within the last 30 days prior to enrollment,
10. 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.
Rationale:
1: As per product labeling and to optimize the treatment and the provided devices,
2-4: In order to select subjects solely with onychomycosis and to avoid any interference or confounding factors with the evaluation, study outcomes and interpretation of results,
5: Due to limited amount of data regarding human pregnancy or lack of data on amorolfine excretion in human milk,
6-8: To avoid potential safety concerns with use of the study drug,
9-10: To comply with ICH-GCP.


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

Health Condition(s) or Problem(s) studied

Mycological confirmed toenail Distal and Lateral Subungual Onychomycosis
MedDRA version: 18.1 Level: PT Classification code 10030338 Term: Onychomycosis System Organ Class: 10021881 - Infections and infestations

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

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: Canesten® Bifonazole cream
Pharmaceutical Form: Cream
INN or Proposed INN: BIFONAZOLE
CAS Number: 60628-96-8
Other descriptive name: BIFONAZOLE
Concentration unit: % (W/V) percent weight/volume
Concentration type: equal
Concentration number: 1-

Trade Name: Canesten® Urea ointment
Product Name: Urea
Pharmaceutical Form: Ointment
INN or Proposed INN: UREA
CAS Number: 57-13-6
Other descriptive name: UREA
Concentration unit: % (W/V) percent weight/volume
Concentration type: equal
Concentration number: 40-

Primary Outcome(s)

Secondary Objective: Subject safety satisfaction

Main Objective: The main objective is to compare subject-reported ease of use, adherence and satisfaction for two modes of treatment of Distal and Lateral Subungual Onychomycosis (DLSO) with Loceryl® Nail Lacquer (Amorolfine) and Canesten® Fungal Nail Treatment Set (Urea 40% ointment and Bifonazole cream) in toenails

Timepoint(s) of evaluation of this end point: Up to week 13 visit (end of study) or early termination

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.

Secondary Outcome(s)

Secondary end point(s): Both the subjects’ adherence to the regimen recommended by the respective labels and the compliance with treatment application procedures 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 13 visit (end of study) or early termination

Secondary ID(s)

RD.03.SPR.105078

Source(s) of Monetary Support

Galderma R&D