on-controlled, open-label study to evaluate tolerability, safety, and efficacy of MOB015B solution for external use in the treatment of mild to moderate fungal infection of the nail in subjects aged 6-17 years

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 30

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

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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