A Multi-centre, Double-blind, Randomized, Vehicle-controlled Study of Efficacy and Safety of Topical MOB015B in the Treatment of Mild to Moderate Distal Subungual Onychomycosis (DSO)
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|ClinicalTrials.gov Identifier: NCT02859519|
Recruitment Status : Completed
First Posted : August 9, 2016
Last Update Posted : December 24, 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: MOB015B Vehicle||Phase 3|
Male or female subjects aged between 12 and 75 years with confirmed DSO involving 20-60% of at least one great toenail will be screened for randomization in this study. The diagnosis of DSO will be confirmed prior to randomization through a positive culture of dermatophytes. In addition, a central blinded assessment of the clinical disease involvement (i.e., affected nail area) will be performed at Screening. Subjects have to meet all eligibility criteria before being randomized in to the study.
Eligible subjects will be randomized to the investigational medicinal products (MOB015B or vehicle) in a ratio of 2:1. The investigational medicinal products (IMPs) will be applied to all affected fingernails and/or toenails for 48 weeks once daily at bedtime. However, fingernails will not be assessed for efficacy.
Since both the IMPs are indistinguishable in appearance and mode of administration, the study will be performed as a double-blind study, i.e., both the investigator and the subject will remain blinded throughout the entire study.
After a 4-week follow-up period without IMP treatment the end of study (EoS) Visit will be performed at Week 52 (Visit 7). The primary efficacy variable will be assessed at Week 52. The end of the clinical study for each individual subject is defined as the EoS Visit at Week 52 (Visit 7). The end of the clinical study is defined as the last visit of the last subject in the study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||365 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Multi-centre, Double-blind, Randomized, Vehicle-controlled Study of Efficacy and Safety of Topical MOB015B in the Treatment of Mild to Moderate Distal Subungual Onychomycosis (DSO)|
|Actual Study Start Date :||October 2016|
|Actual Primary Completion Date :||November 13, 2019|
|Actual Study Completion Date :||November 13, 2019|
Subjects will treat all affected fingernails and/or toenails with MOB015B for 48 weeks once daily at bedtime.
MOB015B - Terbinafine hydrochloride (HCl) 10%, topical solution
Placebo Comparator: MOB015B Vehicle
Subjects will treat all affected fingernails and/or toenails with MOB015B Vehicle for 48 weeks once daily at bedtime.
Drug: MOB015B Vehicle
MOB015B Vehicle without the active ingredient Terbinafine
- Subjects with complete cure of the target toe nail at Week 52 [ Time Frame: Week 52 ]Complete cure was defined as negative fungal culture of dermatophytes, negative direct potassium hydroxide (KOH) microscopy and 0% clinical disease involvement of the target toenail.
- Subjects with mycological cure of the target toe nail at Week 52 [ Time Frame: Week 52 ]Mycological cure was defined as negative fungal culture of dermatophytes and negative direct KOH microscopy of the target toenail.
- Subjects with treatment success of the target toe nail at Week 52 [ Time Frame: Week 52 ]Treatment success was defined as negative fungal culture of dermatophytes, negative direct KOH microscopy and ≤10% clinical disease involvement of the target toenail.
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): NCT02859519
|United States, California|
|Multiple Locations, California, United States|
|United States, Florida|
|Multiple Locations, Florida, United States|
|United States, Idaho|
|Multiple Locations, Idaho, United States|
|United States, Illinois|
|Rolling Meadows, Illinois, United States|
|United States, Minnesota|
|Fridley, Minnesota, United States|
|United States, New Jersey|
|Multiple Locations, New Jersey, United States|
|United States, Oregon|
|Multiple Locations, Oregon, United States|
|United States, Texas|
|Multiple Locations, Texas, United States|
|United States, Virginia|
|Multiple Locations, Virginia, United States|
|Multiple Locations, Canada|