Distal Subungual Onychomycosis
Conditions
Interventions
Product Name: MOB015B
Product Code: [MOB015B]
Pharmaceutical Form: Cutaneous solution
INN or Proposed INN: Terbinafine hydrochloride
CAS Number: 78628-80-5
Current Sponsor code: MOB015B
Other descript
Sponsors
Moberg Pharma AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following inclusion criteria to be considered for enrollment in the study: 1. Male or female subjects 6 to 17 yearsofage (inclusive). 2. Distal subungual onychomycosis of at least oneof the great toenail(s) affecting at least 20% of the target nail to a maximum of 50% and at least 3 mm of unaffected proximal nail. 3. Positive culture of dermatophyte and positive KOH microscopy in samples taken from the same great toenail. 4. Signed written informed assent/consent. 5. Evidence of ability of the great toenail to grow (eg,subject reports cutting toenails at least monthly). 6. Able to comply with the study protocol (in the opinion of the investigator). Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects meeting any of the following exclusion criteria will not be enrolled in the study: 1. Proximal subungual onychomycosis, superficial white onychomycosis, significant dystrophy, severe onychorrhexis, or anatomic abnormalities of the great toenail(s) that in the opinion of the investigator would impair clinical evaluation of onychomycosis. 2. Distal subungual onychomycosis where involvement has extended into the proximal portion of the target nail (unaffected proximal nail is less than 3 mm). 3. Target toenail with greater than 50% disease involvement. 4. Target toenail thickness more than 3 mm. 5. “Spike” of onychomycosisextending to eponychium of the target nail. 6. Presence of dermatophytoma (defined as thick masses of fungal hyphae and necrotic keratin between the nail plate and nail bed) on the target nail. 7. Conditions other than distal subungual onychomycosis known to cause abnormal nail appearance, presence of melanonychia or subungual hematoma that could obscure visualization of nail clearing. 8. Other microbial infections of the target toenail, for example, candida or mold infections without isolation of a dermatophyte 9. Subjects with psoriasis, lichen planus, history of mucocutaneous candidiasis, or other conditions that affect nail appearance and/or growth. 10. Previous target toenail surgery with any residual disfigurement. 11. Topical treatment of the toenails with other antifungal medication within 4 weeks before screening/Visit 1. 12. Use of systemic antifungal treatment within 6 months before screening/Visit 1. 13. History or ongoing/active moderate to severe Moccasin tinea pedis. 14. Having a diagnosis of type 1 diabetes or uncontrolled type 2 diabetes. 15. Known immunodeficiency. 16. Known human immunodeficiency virus (HIV)infection. 17. Participation in another clinical study with an investigational drug or device during the previous 3 months before screening/Visit 1. 18. Known allergy to any of the tested treatment products. 19. A positive pregnancy test at enrollment/baseline (Visit 2). 20. Female subjects physiologically capable of becoming pregnant but are unwilling to refrain from sexual intercourse during the whole study duration or unwilling to use acceptable methods of contraception as agreed with the investigator. 21. Female subjects who are pregnant, breastfeedingmothers, those planning a pregnancy during the study or who become pregnant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To examine theefficacy of MOB015B in children based on assessment of treatment success, mycological cure, clinical cure, and complete cure.;Secondary Objective: To evaluate local tolerability for all treated nails and adjacent skin as well as any other treatment-emergent adverse events (AEs).;Primary end point(s): Treatment success (defined as 0-10% clinical disease involvement of the target toenail and mycologicalcure of target toenail) at Week 48;Timepoint(s) of evaluation of this end point: week 48 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary efficacy endpoints at 48 weeks: - Clinical cure (defined as target toenail free of clinicaldiseaseinvolvement) at Week 48. - Complete cure (defined as negative fungal culture, negative direct potassium hydroxide [KOH] microscopy, and free of clinical disease involvement) of target toenail at Week 48. - Mycological cure (defined as negative fungal culture of dermatophytes and negative direct KOH microscopy) of target toenail at Week 48. Secondary safety endpoints: - Local tolerability of all treated toenails and surrounding skin at baseline and Weeks 4, 8, 12, 24, 36, and 48. - All adverse events (AEs) at baseline and Weeks 4, 8, 12, 24, 36, and 48.;Timepoint(s) of evaluation of this end point: Efficacy: week 48 Safety: weeks 4, 8, 12, 24, 36, and 48 | — |
Countries
Denmark, France, Iceland, Italy, Poland
Contacts
Public ContactCatrine Berlin
Moberg Pharma AB (publ.)
Outcome results
None listed