CompletedPhase 3

A Multi-centre, Double-blind, Randomized, Vehicle-controlled Study of Efficacy and Safety of Topical MOB015B in the Treatment of Mild to Moderate Distal Subungual Onychomycosis (DSO)

United States365 participantsStarted 2016-10

Plain-language summary

The primary objective of this study is to evaluate the efficacy of topical MOB015B in patients with mild to moderate distal subungual onychomycosis (DSO). The secondary objective is to evaluate the safety of topical MOB015B in patients with mild to moderate DSO.

Who can participate

Age range12 Years – 75 Years

SexALL

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Inclusion criteria

✓. Males or females 12 - 75 years of age
✓. Distal subungual onychomycosis (DSO) of at least one of the great toenail(s) affecting 20% to 60% of the target nail
✓. Positive culture for dermatophytes
✓. Written informed consent

Exclusion criteria

✕. Proximal subungual onychomycosis
✕. Distal subungual onychomycosis of both great toenails where involvement has extended into the proximal portion of the target nail (unaffected proximal nail is less than 3 mm)
✕. Target toenail thickness more than 3 mm
✕. "Spike" of onychomycosis extending to eponychium of the target toenail
✕. Presence of dermatophytoma (defined as thick masses of fungal hyphae and necrotic keratin between the nail plate and nail bed) on the target nail
✕. Other conditions than DSO known to cause abnormal nail appearance
✕. Presence of toenail infection other than dermatophytes
✕. Previous target toenail surgery with any residual disfigurement

What they're measuring

Subjects with complete cure of the target toe nail at Week 52

Timeframe: Week 52

Trial details

NCT IDNCT02859519

SponsorMoberg Pharma AB

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-11-13

View on ClinicalTrials.gov More Distal Subungual Onychomycosis trials