This study will be a multicenter, international, randomized, vehicle-controlled, parallel-group, double-blinded study. Subjects who are eligible to participate with a confirmed diagnosis of Distal Subungual onychomycosis (DSO) of the toenail will be randomized and participate in one of the following treatment groups: BB2603-1: 0.01% terbinafine/0.03% polyhexanide formulation, or BB2603-3: 0.03% terbinafine/0.09% polyhexanide formulation, or BB2603-10: 0.1% terbinafine/0.3% polyhexanide formulation, or Vehicle: 0.3% polyhexanide/20% ethanol/water formulation. The subject in each treatment group will be treated twice daily (BID) for 12 weeks and then complete a 28-day post-treatment visit.
Who can participate
Age range18 Years – 99 Years
SexALL
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Inclusion criteria
✓. Male or female ≥18 (and ≤99) at the time of Informed Consent.
✓. Clinically and mycologically (KOH and culture positive for dermatophytes \[microbial infection with fungus belonging to the genus Trichophyton, Microsporum, Epidermophyton\]) confirmed diagnoses of DSO of the target toenail affecting ≥25% to ≤60% of the target toenail as determined through clinimetric measurement.
✓. Signed written informed consent form (ICF) prior to any trial related activity (subjects must have the mental, literate, and legal ability to give a written informed consent, which must comply with the ICH GCP guidelines and local requirements).
✓. Subjects must be willing and able to comply with trial requirements.
✓. Females must be either postmenopausal for ≥1 year (ie 12 consecutive months of amenorrhea, for which there is no other obvious pathologic or physiologic cause), or surgically sterile (tubal ligation, hysterectomy, or bilateral oophorectomy) for at least 6 months or, if of childbearing potential must use either highly effective birth control methods such as:
Exclusion criteria
✕. Any other form of OM except DSO.
What they're measuring
1
Number of subjects with an Early Response for BB2603-10 versus vehicle
. Nails with clinical evidence of no or low distal growth.
✕. DSO of the target toenail where involvement has extended into the proximal portion of the target nail (unaffected proximal nail is ≤3mm) or nail matrix. Any severe OM defined as 3 or more affected toes on one foot.
✕. Estimated target toenail thickness \>3mm.
✕. Presence of dermatophytoma (defined as thick masses of fungal hyphae and necrotic keratin between the nail plate and nail bed) on the target nail.
✕. History of dermatophyte infections unresponsive to systemic or topical anti-fungal drugs (other than OM).
✕. Presence of toenail infection that does not involve a dermatophyte.
✕. Presence of toenail infection that involves a non-dermatophyte fungus or yeast in combination with a dermatophyte, where the non-dermatophyte is, in the opinion of the Investigator, considered to be causative of OM based on clinical appearance, medical history or lifestyle risk.