Study to Evaluate the Efficacy and Safety of Topical MOB015B in the Treatment of Mild to Moderate Distal Subungual Onychomycosis (DSO)
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|ClinicalTrials.gov Identifier: NCT02866032|
Recruitment Status : Completed
First Posted : August 15, 2016
Last Update Posted : October 6, 2020
The primary objective of this study is to evaluate the efficacy of topical MOB015B in patients with mild to moderate distal subungual onychomycosis (DSO).
The secondary objective is to evaluate the safety of topical MOB015B in patients with mild to moderate DSO.
|Condition or disease||Intervention/treatment||Phase|
|Distal Subungual Onychomycosis||Drug: MOB015B Drug: Ciclopirox 80 mg/g||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||452 participants|
|Official 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)|
|Study Start Date :||September 2016|
|Actual Primary Completion Date :||June 10, 2020|
|Actual Study Completion Date :||June 10, 2020|
|Active Comparator: Ciclopirox 80 mg/g||
Drug: Ciclopirox 80 mg/g
- Complete cure of the target nail defined as negative fungal culture of dermatophytes, negative direct KOH microscopy and 0% clinical disease involvement at Week 52 [ Time Frame: Week 52 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02866032
|Multiple Locations, Germany|
|Multiple Locations, Poland|
|Multiple Locations, United Kingdom|