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Antifungal
Topical MOB015B for Fungal Nail Infection
Phase 3
Waitlist Available
Research Sponsored by Moberg Pharma AB
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Distal subungual onychomycosis of at least one of the great toenail(s) affecting 20% to 60% of the target great toenail (verified by a central blinded assessor before randomization)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 52 week
Awards & highlights
Study Summary
This trial is testing a potential new treatment for a fungal infection of the toenails. The study will compare the safety and effectiveness of the new treatment to a placebo.
Who is the study for?
This trial is for people aged 12 to 75 with a fungal nail infection affecting 20-60% of their great toenail, who can cut their nails monthly. They must have a positive test for dermatophytes but no other infections or conditions like psoriasis that affect the nail's appearance. Pregnant women and those on recent antifungal treatments are excluded.Check my eligibility
What is being tested?
The study tests MOB015B, a topical treatment for toenail fungus, against a placebo (vehicle). It's double-blind, meaning neither participants nor researchers know who gets the real treatment versus the placebo until after results are collected.See study design
What are the potential side effects?
While specific side effects aren't listed here, typical ones from topical antifungals include skin irritation, redness, itching or burning at the application site. Systemic side effects are rare since it's applied locally.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a fungal nail infection affecting 20% to 60% of at least one big toenail.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 52 week
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~52 week
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events (Safety)
Proportion of subjects with complete cure of the target toenail
Secondary outcome measures
Proportion of subjects with mycological cure of target toenail
Proportion of subjects with treatment success of target toenail
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: MOB015BExperimental Treatment1 Intervention
Applied at bedtime daily for 8 weeks and then reduced to once weekly for 40 weeks
Group II: Control ArmPlacebo Group1 Intervention
Applied at bedtime daily for 8 weeks and then reduced to once weekly for 40 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MOB015B
2017
Completed Phase 3
~840
Find a Location
Who is running the clinical trial?
Moberg Pharma ABLead Sponsor
11 Previous Clinical Trials
1,461 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have participated in a previous study involving MOB015B treatment.I have not been in a drug or device trial in the last 3 months.I have very weak or no pulse in my feet.I have a known immune system problem or take medication that affects my immune system.My toenail infection is not caused by dermatophyte fungi.I cut my toenails at least once a month.I am not pregnant, breastfeeding, nor planning to become pregnant within the next year.I haven't used any antifungal medication on my toenails in the last 6 weeks.I have a fungal nail infection affecting 20% to 60% of at least one big toenail.I have or had psoriasis or lichen planus.Your toenails are thicker than 3 mm when measured at the tip.I have a severe fungal infection or splitting in my toenail.I have tried oral treatments for nail fungus without success in the last 3 years, or my nail can't look normal because of an injury.I have had toenail surgery in the last 6 months that affects how my nail grows.I have a severe nail infection that could affect its assessment.I haven't taken antifungal medication in the last 6 months.I have nail conditions that could hide nail clearing.My diabetes is not well-controlled, with an HbA1c over 8%.I am between 12 and 75 years old.I do not have severe foot fungus that needs strong treatment.My toenail fungus has spread close to the base of my nail.The doctor found a specific type of fungus in your toenail.
Research Study Groups:
This trial has the following groups:- Group 1: MOB015B
- Group 2: Control Arm
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Fungal Nail Infection Patient Testimony for trial: Trial Name: NCT05279846 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any noted side effects of MOB015B?
"MOB015B received a safety score of 3 from our team at Power. This is because MOB015B is in Phase 3 clinical trials, meaning that there is both evidence of efficacy and multiple rounds of data supporting safety."
Answered by AI
How many people are being included in this clinical trial?
"That is accurate. The most recent information on clinicaltrials.gov reveals that this study, which was established on 5/9/2022, is still recruiting patients. 350 individuals are needed for the trial taking place at 3 hospitals."
Answered by AI
Are there any open appointments left for this clinical trial?
"That is accurate. The clinicaltrials.gov website shows that this research project, which was originally published on May 9th, 2022, is still recruiting patients. They need to 350 people total from 3 different locations."
Answered by AI
Could I possibly join this clinical trial?
"Onychomycosis, or nail fungus, affects 350 people aged 12-75 every year. To be eligible for this study, patients must have distal subungual onychomycosis in at least one great toenail, as verified by a central assessor. In addition, KOH microscopy and culture must show the presence of dermatophytes in the target toenail. Candidates must also demonstrate that their toenails grow regularly (i.e. monthly cutting). Finally, written informed consent/assent is required from all participants who are males or females aged 12 to 75 years old."
Answered by AI
Does this experiment accept subjects that are senior citizens?
"This trial's requirements for age limit participants to those between 12 and 75 years old."
Answered by AI
Who else is applying?
What state do they live in?
New York
What site did they apply to?
Forest Hills Dermatology Group
Progressive Clinical Research, PA
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
What questions have other patients asked about this trial?
When will it begin and is it a paid study? Is there any compensation? Travel or lost time from work?
PatientReceived 2+ prior treatments
Why did patients apply to this trial?
I have two toenails on my right foot that have some type of fungus. I read your study and I am a perfect fit and I live in San Antonio and can begin ASAP and have an open schedule.
PatientReceived 1 prior treatment
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