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Clinical Trials/EUCTR2022-001797-59-PL
EUCTR2022-001797-59-PL
Active, not recruiting
Phase 1

A multi-center, single-arm, open-label study to evaluate tolerability, safety, and efficacy of topical MOB015B solution in the treatment of mild to moderate distal subungual onychomycosis (DSO) in subjects aged 6-17 years

Moberg Pharma AB (publ.)0 sites30 target enrollmentMarch 8, 2023
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ConditionsDistal Subungual OnychomycosisMedDRA version: 20.0Level: SOCClassification code 10021881Term: Infections and infestationsSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Distal Subungual Onychomycosis
Sponsor
Moberg Pharma AB (publ.)
Enrollment
30
Status
Active, not recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 8, 2023
End Date
TBD
Last Updated
last year
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility 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: 30
  • •F.1\.2 Adults (18\-64 years) no

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.

Outcomes

Primary Outcomes

Not specified

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