A multicentre, randomized, controlled study of the efficacy, safety and cost-effectiveness of a sequential therapy with RV4104A ointment, ciclopiroxolamine cream and ciclopirox film-forming solution compared with amorolfine nail lacquer alone for the treatment of dermatophytic onychomycosis (toenail) without matrix involvement - ONICO

Phase 1

• Conditions: Patients suffering from distal-lateral or lateral subungual onychomycosis of one great toenail (the target nail) without matrix involvement; MedDRA version: 9.1Level: LLTClassification code 10030338Term: Onychomycosis

• Registration Number: EUCTR2009-011125-14-FR
• Lead Sponsor: Pierre Fabre Dermatologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-05-28
• Study Completion: 2011-08-29
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 260

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified