A Phase 3 interventional study of MOB015B and Ciclopirox 80 mg/g in Distal Subungual Onychomycosis, sponsored by Moberg Pharma AB. Completed at 3 sites in 3 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-10-06.
Sponsored by Moberg Pharma AB · Phase 3 and Interventional
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 5th 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 13th registered.
158 studies on the registry are indexed under Onychomycosis; 16 are open to participants now.
This study's enrollment of 452 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: 18 Years to 75 Years · all sexes.
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.
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.
Drug: MOB015B
Drug: Ciclopirox 80 mg/g
Drug page: Ciclopirox
Complete cure of the target nail defined as negative fungal culture of dermatophytes, negative direct KOH microscopy and 0% clinical disease involvement at Week 52
Time frame: Week 52
This study is completed, as verified in Oct 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