Topical MOB015B for Fungal Nail Infection

Recruiting at 37 trial locations

Overseen By Amir Tavakkol, Ph.D.,Dip. Bact

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Moberg Pharma AB

Must not be taking: Antifungals, Immunosuppressants

Disqualifiers: Psoriasis, Diabetes, Immunodeficiency, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 48 weeks

350 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests MOB015B, a new topical treatment for nail fungus, on patients with DSO. The treatment uses an antifungal ingredient to kill the fungi and is applied regularly over several months.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have used topical antifungal treatments on your toenails within 6 weeks before the study or systemic antifungal treatments within 6 months before the study.

What data supports the effectiveness of the treatment MOB015B for fungal nail infection?

Research on similar treatments, like efinaconazole, shows that topical antifungal solutions can be effective for treating fungal nail infections, with some patients experiencing a complete cure. This suggests that topical treatments, including MOB015B, may also be effective. ^{1 2 3 4 5}

Is MOB015B safe for treating fungal nail infections?

There is no specific safety data available for MOB015B in the provided research articles. ^{4 6 7 8 9}

How is the drug MOB015B different from other treatments for fungal nail infections?

MOB015B is a topical treatment for fungal nail infections, which means it is applied directly to the nail, potentially avoiding the side effects and drug interactions associated with oral antifungal medications. This approach aims to improve drug delivery to the nail, which is challenging due to the nail's low permeability, and offers an alternative for patients who cannot take oral antifungals. ^{3 10 11 12 13}

Eligibility Criteria

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.

Inclusion Criteria

I cut my toenails at least once a month.

Signed written informed consent and assent (if applicable)

I have a fungal nail infection affecting 20% to 60% of at least one big toenail.

Exclusion Criteria

Known allergy to any of the tested treatment products

You have participated in a previous study involving MOB015B treatment.

Psychiatric condition that might limit the participation in the study and/or that lead to the assumption that the subject's ability to completely understand the consequences of consent is missing

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive topical MOB015B or placebo daily for 8 weeks, then once weekly for 40 weeks

48 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• MOB015B
• Placebo
• Vehicle

Trial Overview 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.

Participant Groups

Group I: MOB015B Experimental Treatment 1 Intervention

Applied at bedtime daily for 8 weeks and then reduced to once weekly for 40 weeks

Group II: Control Arm Placebo Group 1 Intervention

Applied at bedtime daily for 8 weeks and then reduced to once weekly for 40 weeks

Who Is Running the Clinical Trial?

Moberg Pharma AB

Lead Sponsor

Trials

14

Recruited

2,100+

References

1. United States pubmed.ncbi.nlm.nih.gov

A new concept in the topical treatment of onychomycosis with cyanoacrylate, undecylenic acid, and hydroquinone. [2016]

2. United States pubmed.ncbi.nlm.nih.gov

Topical treatment of onychomycosis as a realistic option to systemic therapy: a case report. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Application of Nail Polish During Topical Management of Onychomycosis: Are Data Available to Guide the Clinician About What to Tell Their Patients? [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Efinaconazole Topical Solution, 10%, for the Treatment of Mild and Moderate Toenail Onychomycosis. [2022]

5. England pubmed.ncbi.nlm.nih.gov

How effective is efinaconazole in the management of onychomycosis? [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Characterization of Antifungal Activity and Nail Penetration of ME1111, a New Antifungal Agent for Topical Treatment of Onychomycosis. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of luliconazole 5% nail solution for the treatment of onychomycosis: A multicenter, double-blind, randomized phase III study. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Tavaborole - a treatment for onychomycosis of the toenails. [2017]

9. Egypt pubmed.ncbi.nlm.nih.gov

New concepts in median nail dystrophy, onychomycosis, and hand, foot, and mouth disease nail pathology. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Tinea and Onychomycosis. [2018]

11. United States pubmed.ncbi.nlm.nih.gov

Tavaborole, Efinaconazole, and Luliconazole: Three New Antimycotic Agents for the Treatment of Dermatophytic Fungi. [2018]

12. United States pubmed.ncbi.nlm.nih.gov

Clinical evaluation of safety and efficacy of a new topical treatment for onychomycosis. [2011]

13. England pubmed.ncbi.nlm.nih.gov

1st meeting on topical drug delivery to the nail. [2019]