MOB015B in the treatment of mild to moderate DSO
Research type
Research Study
Full title
A multi-centre, randomized, two-armed, parallel group and evaluator-blinded study of efficacy and safety of topical MOB015B in the treatment of mild to moderate distal subungual onychomycosis (DSO)
IRAS ID
242051
Contact name
Alan Wade
Contact email
Sponsor organisation
Moberg Pharma AB (publ)
Eudract number
2016-001204-39
Clinicaltrials.gov Identifier
CRO Trial code (TFS), MOE1009
Duration of Study in the UK
1 years, 3 months, 16 days
Research summary
Distal subungual onychomycosis (DSO) is the most common form of all types of onychomycosis (OM), in which fungi invade the underside of the nail plate. At first, onychomycosis appears to be only a cosmetic concern as nails may thicken, disfigure, split and discolor. However, 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.
Onychomycosis is often difficult to treat and relapse is common. Current treatments for OM include procedures such as nail avulsion and debridement by chemical or surgical procedures, topical and oral antifungals, as well as device-based therapies. Today, systemically administered drugs are the most effective treatment of OM. However, 20-50% of all patients fail to respond and systemic adverse drug reactions (ADRs) may occur. Since the infection does not resolve spontaneously, the development of easy to handle topical treatments with the capacity of effective penetration of the nail plate combined with a favourable safety is of great importance.
The test product, MOB015B, is a newly developed solution for the topical treatment of DSO containing the very well-known active ingredient terbinafine.
Based on the results of a phase II study in 25 subjects topical administration of MOB015B was found to be safe and to lead to a high rate of mycological cure as well as greater local terbinafine concentrations in the nail tissue compared to those reached after oral treatment
(250 mg tablets).This planned pivotal phase III study will be performed as an evaluator-blinded trial to further investigate the efficacy (effectiveness) and safety of topical MOB015B in patients with mild to moderate DSO caused by dermatophyte infection.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
18/WM/0080
Date of REC Opinion
31 Mar 2018
REC opinion
Favourable Opinion