OnychomycosisPhase 2NCT01246518
Efficacy and Safety of Two Treatment Regimens of Topical MOB015 in Adults With Distal Subungual Onychomycosis
A Phase 2 study testing MOB015 in people with Onychomycosis, run by Moberg Pharma AB at 1 site in Sweden.
Trial summary
Onychomycosis is a fungal infection that affects fingernails and/or toenails. The purpose of this trial is to investigate if MOB015 is effective and safe for treatment of patients with fungal infection of the toenails. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Onychomycosis
- What is being tested?
- MOB015
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteSweden
- Study dates
- Dec 2010to Oct 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female
- 18 - 70 years
- DSO of at least one of the great toe(s) affecting 25 % to 75 % of the target nail (verified by blinded assessor before randomization)
- Positive culture for dermatophytes (i.e. Trichophyton species; T. rubrum or T. mentagrophytes)
- Signed written informed consent
Who cannot join
- Proximal subungual onychomycosis
- DSO of both great toenails where involvement has extended into the proximal portion of the target nail (unaffected proximal nail is less than 2 mm)
- "Spike" of onychomycosis extending to eponychium of the target nail
- Presence of dermatophytoma (defined as demarcated and localised thick masses of fungal hyphae and necrotic keratin between the nail plate and nail bed) on the target nail
- Other conditions than DSO known to cause abnormal nail appearance
- Topical antifungal treatment of the nails within 1 month before screening
Show all 16Show fewer
- Systemic use of antifungal treatment within 3 months before screening
- Signs of severe peripheral circulatory insufficiency
- Immunosuppression
- Participation in another clinical trial with an investigational drug or device during the previous 4 weeks before screening
- Known allergy to any of the tested treatment products
- A pregnancy test indicating pregnancy in a woman of childbearing potential at screening (visit 1)
- Pre-menopausal (last menstruation ≤ 1 year prior to screening) sexually active women who :
- are pregnant or nursing
- are not surgically sterile
- are of child bearing potential and not practising an acceptable method of birth control, or does not plan to continue practising an acceptable method of birth control throughout the trial (acceptable methods include intrauterine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open, Multi-centre Trial Comparing the Efficacy and Safety of Two Different Treatment Regimens of Topical MOB015 Treatment of Distal Subungual Onychomycosis (DSO)
Onychomycosis is a fungal infection that affects fingernails and/or toenails.
The purpose of this trial is to investigate if MOB015 is effective and safe for treatment of patients with fungal infection of the toenails.
- Conditions
- Onychomycosis
- Being tested
- MOB015
- Keywords
- distal subungual onychomycosis
- Medical subject headings
- Onychomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOB015Drug
Arm 1; MOB015 once a day for 3 months. Arm 2; MOB015 once a day for 9 months.
| Study group | Role | What they receive |
|---|---|---|
| MOB015 for 3 months | Active comparator | Not described Receives: Drug: MOB015 |
| MOB015 for 9 months | Active comparator | Not described Receives: Drug: MOB015 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mycological cure of target nail at 12 months, defined as negative fungal culture and negative direct microscopy.
Measured: 12 months
Secondary outcomes (1)
Proportion of patients with negative fungal culture, negative direct microscopy and complete cure.
Measured: 1, 3, 6, 9, 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2010 (estimated)
- Study startDec 2010
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OnychomycosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Moberg Pharma AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jan Faergemann, MD, PhD, Principal investigator, Dept. of Dermatology, Sahlgrenska University Hospital, Gothenburg, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01246518
- Sponsor's protocol ID
- MOB015-I
- Status last verified
- Sep 2011
- First submitted
- 19 Nov 2010
- Last updated
- 25 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Multi-centre Trial Comparing the Efficacy and Safety of Two Different Treatment Regimens of Topical MOB015 Treatment of Distal Subungual Onychomycosis (DSO)
- ClinicalTrials.gov ID
- NCT01246518
- Acronym / sponsor ID
- MOB015-I
- Conditions
- Onychomycosis
- Keywords
- distal subungual onychomycosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Moberg Pharma ABIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 23 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Onychomycosis is a fungal infection that affects fingernails and/or toenails.
The purpose of this trial is to investigate if MOB015 is effective and safe for treatment of patients with fungal infection of the toenails.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MOB015 for 3 months | Active comparator | Drug: MOB015 |
| MOB015 for 9 months | Active comparator | Drug: MOB015 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female
- 18 - 70 years
- DSO of at least one of the great toe(s) affecting 25 % to 75 % of the target nail (verified by blinded assessor before randomization)
- Positive culture for dermatophytes (i.e. Trichophyton species; T. rubrum or T. mentagrophytes)
- Signed written informed consent
Key exclusion criteria (16 listed)
- Proximal subungual onychomycosis
- DSO of both great toenails where involvement has extended into the proximal portion of the target nail (unaffected proximal nail is less than 2 mm)
- "Spike" of onychomycosis extending to eponychium of the target nail
- Presence of dermatophytoma (defined as demarcated and localised thick masses of fungal hyphae and necrotic keratin between the nail plate and nail bed) on the target nail
- Other conditions than DSO known to cause abnormal nail appearance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MOB015Arm 1; MOB015 once a day for 3 months. Arm 2; MOB015 once a day for 9 months. | Drug | MOB015 for 3 months, MOB015 for 9 months |
Primary outcome
Mycological cure of target nail at 12 months, defined as negative fungal culture and negative direct microscopy.
Time frame: 12 months
1 secondary outcome
Proportion of patients with negative fungal culture, negative direct microscopy and complete cure.
Time frame: 1, 3, 6, 9, 12 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Faergemann, MD, PhD principal investigator
Dept. of Dermatology, Sahlgrenska University Hospital, Gothenburg, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MOB015 in people with Onychomycosis, run by Moberg Pharma AB at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mycological cure of target nail at 12 months, defined as negative fungal culture and negative direct microscopy. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2012.