A Phase 3 interventional study of MOB015B and MOB015B Vehicle in Distal Subungual Onychomycosis, sponsored by Moberg Pharma AB. Completed at 10 sites in 2 countries. Open to participants aged 12 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-12-24.
Sponsored by Moberg Pharma AB · Phase 3, Interventional, and Treatment
Among 20 studies testing terbinafine in Onychomycosis — 1 open to participants now, 2 under way, 1 of them phase 3. Terbinafine · Onychomycosis.
Among the 20 studies testing terbinafine in Onychomycosis, this one is the 6th largest by enrollment of the 19 interventional ones, is one of 2 that started in 2016, is one of 10 in phase 3, and was the 12th registered.
158 studies on the registry are indexed under Onychomycosis; 16 are open to participants now.
This study's enrollment of 365 is above the median of 60 across 143 interventional studies indexed under Onychomycosis.
Browse Onychomycosis studies →1 of the 20 studies testing terbinafine in Onychomycosis is open now.
Terbinafine: first FDA approval 1992 (LAMISIL). What it is approved for, and how studies give it, is on its page →
Of the 9 Onychomycosis studies recruiting now, 3 (33%) set no upper age limit and 5 (56%) stop at 75 or younger; 1 take children under 18; 2 take healthy volunteers.
This study: 12 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →20 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 2 started in 2016.
Median enrollment 100 across the 19 interventional studies. Of the 14 that completed or were terminated, 3 (21%) have results posted.
17 of 20 have an industry lead sponsor. The 10 most frequent:
Moberg Pharma AB is the lead sponsor of 14 studies on the registry; none are open to participants now.
Moberg Pharma AB has 7 studies filed under Onychomycosis — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 20 studies testing terbinafine in Onychomycosis, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
Male or female subjects aged between 12 and 75 years with confirmed DSO involving 20-60% of at least one great toenail will be screened for randomization in this study. The diagnosis of DSO will be confirmed prior to randomization through a positive culture of dermatophytes. In addition, a central blinded assessment of the clinical disease involvement (i.e., affected nail area) will be performed at Screening. Subjects have to meet all eligibility criteria before being randomized in to the study.
Eligible subjects will be randomized to the investigational medicinal products (MOB015B or vehicle) in a ratio of 2:1. The investigational medicinal products (IMPs) will be applied to all affected fingernails and/or toenails for 48 weeks once daily at bedtime. However, fingernails will not be assessed for efficacy.
Since both the IMPs are indistinguishable in appearance and mode of administration, the study will be performed as a double-blind study, i.e., both the investigator and the subject will remain blinded throughout the entire study.
After a 4-week follow-up period without IMP treatment the end of study (EoS) Visit will be performed at Week 52 (Visit 7). The primary efficacy variable will be assessed at Week 52. The end of the clinical study for each individual subject is defined as the EoS Visit at Week 52 (Visit 7). The end of the clinical study is defined as the last visit of the last subject in the study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects will treat all affected fingernails and/or toenails with MOB015B for 48 weeks once daily at bedtime.
Drug: MOB015B
Subjects will treat all affected fingernails and/or toenails with MOB015B Vehicle for 48 weeks once daily at bedtime.
Drug: MOB015B Vehicle
MOB015B - Terbinafine hydrochloride (HCl) 10%, topical solution
MOB015B Vehicle without the active ingredient Terbinafine
Subjects with complete cure of the target toe nail at Week 52
Complete cure was defined as negative fungal culture of dermatophytes, negative direct potassium hydroxide (KOH) microscopy and 0% clinical disease involvement of the target toenail.
Time frame: Week 52
Subjects with mycological cure of the target toe nail at Week 52
Mycological cure was defined as negative fungal culture of dermatophytes and negative direct KOH microscopy of the target toenail.
Time frame: Week 52
Subjects with treatment success of the target toe nail at Week 52
Treatment success was defined as negative fungal culture of dermatophytes, negative direct KOH microscopy and ≤10% clinical disease involvement of the target toenail.
Time frame: Week 52
This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Terbinafine
Moberg Pharma AB