Patients suffering from distal-lateral or lateral subungual onychomycosis of one great toenail (the target nail) without matrix involvement MedDRA version: 9.1 Level: LLT Classification code 10030338 Term: Onychomycosis
Conditions
Interventions
Trade Name: MYCOSTER 1% cream
Pharmaceutical Form: Cream
INN or Proposed INN: CICLOPIROX OLAMINE
CAS Number: 41621492
Concentration unit: % (W/W) percent weight/weight
Concentration type: equal
Concen
Sponsors
Pierre Fabre Dermatologie
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Relating to the population: - Over 18 year-old male or female patient - Patient who has signed the informed consent form - Patient willing to attend the planned study visits at the investigational centre and to comply with all study requirements - If required by national regulations, patient must be registered with health social security or health insurance - Female patient of childbearing potential must use an efficient contraceptive method for at least 2 months prior to screening visit - Female patient of childbearing potential must have a negative urinary pregnancy test at the screening visit Relating to the disease: - Clinical diagnosis of distal-lateral or lateral subungual onychomycosis of one great toenail (the target nail) without matrix involvement - Target nail plate showing between 25% and 60% of clinically infected area - Patient must have at least 2 mm of unaffected proximal nail area - Target nail infection due exclusively to a dermatophyte (from positive fungal culture as reported by the central mycological laboratory) 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Relating to the population: - Female patient who is pregnant or planning a pregnancy during the course of the study or breast feeding - Patient who is unable to understand the information (for linguistic or psychiatric reasons) and to give his/her consent to participate - Patient who has forfeited his/her freedom by administrative or legal decision or under guardianship - Patient with known hypersensitivity to investigational products’ ingredient(s) - Patient who is currently participating or who has participated in another clinical study within 4 weeks prior to screening visit Relating to the disease: - Patient with more than 3 affected toenails - Patient with onychomycosis with matrix involvement - Patient with psoriasis, lichen planus or other abnormalities that could result in clinically abnormal toenail(s) - Patient with moccasin-type tinea pedis - Patient who has received systemic antifungal therapy or topical antifungal nail lacquer within 3 months or any other topical antifungal therapy applied to toenails within 2 months prior to screening visit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate and compare the efficacy of the sequential association RV4104A ointment followed by ciclopiroxolamine cream and ciclopirox film-forming solution versus amorolfine nail lacquer alone in the treatment of patients with dermatophytic onychomycosis (toenail) without matrix involvement ;Secondary Objective: To evaluate and compare the safety of the sequential association RV4104A ointment followed by ciclopiroxolamine cream and film-forming solution versus amorolfine alone in the treatment of patients with dermatophytic onychomycosis (toenail) without matrix involvement To evaluate and compare the cost-effectiveness of the sequential association RV4104A ointment followed by ciclopiroxolamine cream and film-forming solution versus amorolfine alone in the treatment of patients with dermatophytic onychomycosis (toenail) without matrix involvement ;Primary end point(s): Treatment success at endpoint (D336, week 48) in each group: Treatment Success at D336 is defined as clinical cure¤ and mycological cure# ¤ Clinical cure at D336 (judged by the investigator) is defined as disappearance of all lesions on target nail or residual disease of no more than 10% of the original total diseased surface (the remaining diseased surface should involve only the distal third). # Mycological cure at D336 defined as negative direct microscopy examination and negative fungal culture (as reported by the central mycological laboratory). | — |
Countries
France
Outcome results
None listed