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CompletedNCT02866032Updated Oct 6, 2020

Study to Evaluate the Efficacy and Safety of Topical MOB015B in the Treatment of Mild to Moderate Distal Subungual Onychomycosis (DSO)

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

Phase
Phase 3
Study type
Interventional
Enrollment
452
Ages
18 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 20 studies testing terbinafine in Onychomycosis — 1 open to participants now, 2 under way, 1 of them phase 3. Terbinafine · Onychomycosis.

Enrollment
5th of 19
452 · median 100
Started
2016
with 1 other
Phase 3
10 of 20
none open now
Registered
13th of 20
by date
Lead sponsor
5 of 20
Moberg Pharma AB

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.

By phase

20 studies; the count open now beside each. This study's row is marked.

Phase 3this study10 · 0 open
Phase 25 · 1 open
Phase 13 · 0 open
No phase2 · 0 open

By the year they started

First in 2004; this study’s year is marked. 2 started in 2016.

Tested beside terbinafine

Size and results

Median enrollment 100 across the 19 interventional studies. Of the 14 that completed or were terminated, 3 (21%) have results posted.

Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 20 studies testing terbinafine in Onychomycosis, or all of them as a file.
02

Study summary

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.

03

Conditions studied

  • Distal Subungual Onychomycosis

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04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All

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.

Inclusion criteria

  1. Males or females 18 - 75 years of age
  2. Distal subungual onychomycosis (DSO) of at least one of the great toenail(s) affecting 20% to 60% of the target nail
  3. Positive culture for dermatophytes
  4. Signed written

Exclusion criteria

Exclusion Criteria:

  1. Proximal subungual onychomycosis
  2. Distal subungual onychomycosis of both great toenails where involvement has extended into the proximal portion of the target nail (unaffected proximal nail is less than 3 mm)
  3. Target toenail thickness more than 3 mm
  4. "Spike" of onychomycosis extending to eponychium of the target toenail
  5. Presence of dermatophytoma (defined as thick masses of fungal hyphae and necrotic keratin between the nail plate and nail bed) on the target nail
  6. Other conditions than DSO known to cause abnormal nail appearance
  7. Presence of toenail infection other than dermatophytes
  8. Previous target toenail surgery with any residual disfigurement
  9. Topical treatment of the nails with other antifungal medication or medical device within 6 weeks before screening/Visit 1
  10. Systemic use of antifungal treatment within 6 months before screening/ Visit 1
  11. Severe moccasin tinea pedis
  12. Signs of severe peripheral circulatory insufficiency
  13. Uncontrolled diabetes mellitus
  14. Known immunodeficiency
  15. Participation in another clinical trial with an drug or device during the previous 3 months before Baseline/ Visit 2
  16. Known allergy to any of the tested treatment products
  17. A positive pregnancy test indicating pregnancy in a woman of at Baseline/ Visit 2
  18. Females who are pregnant or breastfeeding
  19. Pre-menopausal (last menstruation ≤ 1 year prior to screening) sexually active women who are of childbearing potential and are not practicing an acceptable method of , or do not plan to continue practicing an acceptable method of birth control throughout the trial
  20. Patients previously randomized in this study
  21. History of, or current drug or alcohol abuse
  22. Psychiatric condition that might limit the participation in the study and/or that lead to the assumption that the patient's ability to completely understand the consequences of consent is missing
  23. Close affiliation with the investigator (e.g. a close relative) or persons working at a study site, or patient who is an employee of the sponsor's company
  24. Patients who are institutionalized because of legal or regulatory order
  25. Any diseases or circumstances in which the patient should not participate in the study in the opinion of the investigator
Terms in these criteria, in plain language(4)

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.

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.

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.

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.

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.

05

Study design

Phase
Phase 3
Enrollment
452 participants (actual)

Study arms

  • Experimental
    MOB015B

    Drug: MOB015B

  • Active comparator
    Ciclopirox 80 mg/g

    Drug: Ciclopirox 80 mg/g

Interventions

06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

3 sites
  • Multiple Locations, Germany
  • Multiple Locations, Poland
  • Multiple Locations, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 6, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02866032
Lead sponsor
Moberg Pharma AB
Responsible party
Sponsor
First posted
Aug 15, 2016
Start date
Sep 2016
Primary completion
Jun 10, 2020
Completion
Jun 10, 2020
Last update
Oct 6, 2020
View the source record on ClinicalTrials.gov ↗

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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

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