CompletedPhase 3

Study to Evaluate the Efficacy and Safety of Topical MOB015B in the Treatment of Mild to Moderate Distal Subungual Onychomycosis (DSO)

Germany, Poland, United Kingdom452 participantsStarted 2016-09

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 range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Males or females 18 - 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
✓. Signed 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

Complete cure of the target nail defined as negative fungal culture of dermatophytes, negative direct KOH microscopy and 0% clinical disease involvement at Week 52

Timeframe: Week 52

Trial details

NCT IDNCT02866032

SponsorMoberg Pharma AB

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-06-10

View on ClinicalTrials.gov More Distal Subungual Onychomycosis trials