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A Trial Involving Treatment of BB2603 in Subjects With Distal Subungual Onychomycosis of the Toenail

NCT04188574 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 111

Last updated 2023-08-01

No results posted yet for this study

Summary

This study will be a multicenter, international, randomized, vehicle-controlled, parallel-group, double-blinded study. Subjects who are eligible to participate with a confirmed diagnosis of Distal Subungual onychomycosis (DSO) of the toenail will be randomized and participate in one of the following treatment groups: BB2603-1: 0.01% terbinafine/0.03% polyhexanide formulation, or BB2603-3: 0.03% terbinafine/0.09% polyhexanide formulation, or BB2603-10: 0.1% terbinafine/0.3% polyhexanide formulation, or Vehicle: 0.3% polyhexanide/20% ethanol/water formulation. The subject in each treatment group will be treated twice daily (BID) for 12 weeks and then complete a 28-day post-treatment visit.

Conditions

Interventions

DRUG

BB2603-1

Treatment with topical spray twice-daily (BID) BB2603-1: 0.01% terbinafine

DRUG

BB2603-3

Treatment with topical spray twice-daily (BID) BB2603-3: 0.03% terbinafine

DRUG

BB2603-10

Treatment with topical spray twice-daily (BID) BB2603-10: 0.1% terbinafine

OTHER

Vehicle

Treatment with topical spray twice-daily (BID): 0.3% polyhexanide/ 20% ethanol/ water formulation.

Sponsors & Collaborators

  • IQVIA Biotech

    collaborator INDUSTRY

  • Blueberry Therapeutics

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-22
Primary Completion
2022-12-06
Completion
2023-06-28
FDA Drug
Yes

Countries

  • Czechia
  • Germany
  • Poland

Study Locations

More Related Trials

Entities

Diseases

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 NCT04188574 on ClinicalTrials.gov