Active — Not RecruitingPhase 3

A Vehicle-controlled Study of Topical MOB015B in the Treatment of Distal Subungual Onychomycosis (DSO)

United States350 participantsStarted 2022-05-09

Plain-language summary

This is a Phase 3 multicenter, double-blind study to evaluate the safety and efficacy of vehicle-controlled topical MOB015B in the treatment of Distal Subungual Onychomycosis (DSO)

Who can participate

Age range12 Years – 75 Years

SexALL

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Inclusion criteria

✓. Males or females 12 to 75 years of age
✓. Distal subungual onychomycosis of at least one of the great toenail(s) affecting 20% to 60% of the target great toenail (verified by a central blinded assessor before randomization)
✓. Positive KOH microscopy and culture for dermatophytes in the target toenail
✓. Ability of the great toenail to grow (e.g., subject reports cutting toenails at least monthly)
✓. Signed written informed consent and assent (if applicable)

Exclusion criteria

✕. Proximal subungual onychomycosis, superficial white onychomycosis, or significant dystrophy judged clinically by the blinded assessor or by the Investigator that may interfere with clinical evaluation of onychomycosis
✕. Distal subungual onychomycosis where disease involvement has extended into the proximal portion of the target toenail and the unaffected proximal nail is less than 3 mm measured from proximal nail fold
✕. Target toenail thickness more than 3 mm measured at the distal end
✕. "Spike" of onychomycosis extending to eponychium of the target toenail
✕. Presence of dermatophytoma (defined as thick masses of fungal hyphae and necrotic keratin) or severe onychorrhexis on the target toenail
✕. Nail conditions other than DSO that are known to cause abnormal nail appearance, presence of melanonychia or subungual hematoma that could obscure visualization of nail clearing
✕. Other microbial infections of the target toenail, for example, candida or mold infections without isolation of a dermatophyte
✕. Previous target toenail surgery (within 6 months) with any residual disfigurement that will impact efficacy outcome or will not allow nail to grow normally, as judged by the Investigator

What they're measuring

Proportion of subjects with complete cure of the target toenail

Timeframe: 52 Week

Incidence of adverse events (Safety)

Timeframe: 52 Week

Trial details

NCT IDNCT05279846

SponsorMoberg Pharma AB

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-01

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