Clinical Trials Logo

Clinical Trial Summary

This is a Phase 3 multicenter, double-blind study to evaluate the safety and efficacy of vehicle-controlled topical MOB015B in the treatment of Distal Subungual Onychomycosis (DSO)


Clinical Trial Description

Distal subungual onychomycosis (DSO) is the most common form of Onychomycosis, in which fungi invade the underside of the nail plate. The infection may worsen, spread to other uninfected areas or infect other people. Without treatment the disease may have an impact on an individual's quality of life. MOB015B is a newly developed topical solution for the treatment of nail fungus (onychomycosis) containing the active antifungal ingredient terbinafine. All ingredients in MOB015B have a well-established use in approved pharmaceuticals for dermatological use. The purpose of this study is to evaluate the efficacy and safety of a new reduced dose treatment regimen of MOB015B whereby the investigational medicinal product (IMP) is applied daily for 8 weeks and then reduced to once weekly treatment for 40 weeks. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05279846
Study type Interventional
Source Moberg Pharma AB
Contact
Status Active, not recruiting
Phase Phase 3
Start date May 9, 2022
Completion date March 2024

See also
  Status Clinical Trial Phase
Completed NCT03098615 - Study Evaluating the Effect of Jublia on Dermatophytomas Phase 4
Recruiting NCT01666002 - Treatment of Onychomycosis Using a 0.65 Millisecond Pulsed Nd:YAG 1064 nm Laser N/A
Completed NCT01180491 - A Clinical Investigation on Early Visible Effects of Application of K101 During 8 Weeks on Discoloured and Deformed Nails Resulting From Onychomycosis N/A
Terminated NCT01208168 - Safety & Efficacy of NAB001 in the Treatment of Mild to Moderate Onychomycosis of the Toenails Phase 3
Terminated NCT01208129 - Safety and Efficacy of NAB001 in the Treatment of Mild to Moderate Onychomycosis of the Toenails Phase 3
Completed NCT00385502 - A Trial of the Safety and Efficacy of EcoNailâ„¢ in the Treatment of Fungus Infections of the Great Toenail Phase 2
Completed NCT00253305 - Topical Gel Anti-Fungal Agent for Tinea Unguium Phase 2
Not yet recruiting NCT05809297 - Diode Laser and Photodynamic Therapy Vs. Ciclopirox. Phase 4
Completed NCT03405818 - An Evaluation of the Safety and Pharmacokinetics of Tavaborole Topical Solution for the Treatment of Fungal Disease of the Toenail in Children and Adolescents Phase 4
Completed NCT02588599 - A Retrospective Analysis of the Effects of Low Level Laser Therapy on Toenail Onychomycosis N/A
Recruiting NCT02436291 - Evaluation of the Efficacy of CURE-EX Treatment in Onychomycosis Phase 4
Completed NCT01851590 - Resin vs. Amorolfine vs. Terbinafine Treatment in Onychomycosis Phase 4
Completed NCT01452490 - Diode Laser Treatment of Onychomycosis N/A
Withdrawn NCT00938925 - Effectiveness of Podiatry Care on Onychomycosis (EPOCAON) N/A
Recruiting NCT00808366 - Efficacy and Safety of RV4104A Ointment in Onychomycosis N/A
Completed NCT00768768 - Iontophoretic Application of Terbinafine Gel to the Large Toe Nail Phase 1
Completed NCT00781820 - Comparative Efficacy of Bifonazole Cream vs Placebo After Nail Ablation With Urea Paste Phase 3
Completed NCT00777868 - A Dose-Ranging Study Evaluating the Safety and Efficacy of IDP-108 in Patients With Onychomycosis Phase 2
Recruiting NCT06074315 - Evaluation of the Effectiveness of Nail Genesis DLSO Product for Onychomycosis N/A
Completed NCT01039883 - A Study to Compare the Blood Levels of Albaconazole in Healthy Subjects Who Have Received a Single Dose of 400 mg Albaconazole as a Tablet Versus Albaconazole as a Capsule Phase 1