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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)

NCT02859519 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 365

Last updated 2020-12-24

No results posted yet for this study

Summary

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.

Conditions

  • Distal Subungual Onychomycosis

Interventions

DRUG

MOB015B

MOB015B - Terbinafine hydrochloride (HCl) 10%, topical solution

DRUG

MOB015B Vehicle

MOB015B Vehicle without the active ingredient Terbinafine

Sponsors & Collaborators

  • Moberg Pharma AB

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2019-11-13
Completion
2019-11-13

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02859519 on ClinicalTrials.gov