NCT04315051

A Trial of Safety/Efficacy of Test Article in Patients With Interdigital T. Pedis

Clinical Trial Protocol DBI-204 Double-Blind, Randomized, Placebo Controlled Trial of the Safety and Efficacy of DBI-001 Gel in Patients With Interdigital Tinea Pedis

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: DermBiont, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Placebo Controlled Trial of the Safety and Efficacy of DBI-001 in Patients with Interdigital Tinea pedis (T. pedis)

Detailed description

Double-Blind, Randomized, Placebo Controlled Trial of the Safety and Efficacy of DBI-001 Gel in Patients with Interdigital Tinea pedis (T. pedis). The primary objective is to observe the antimicrobial effect of a daily application of DBI-001Gel for 4 weeks in patients with interdigital T. pedis based on the change from culture positive for a dermatophyte to culture negative as determined by routine mycology culture.

Conditions

• Interdigital Tinea Pedis

Interventions

Type	Name	Description
DRUG	Cohort 1 J. Lividum	Subject to apply DBI-001 Gel on each foot covering all web spaces, the plantar and lateral aspects, toes and toenails
OTHER	Placebo Gel	Subject to apply Placebo Gel daily on each foot covering all web spaces, the plantar and lateral aspects, toes and toenails.

Timeline

• Start date: 2019-09-12
• Primary completion: 2020-06-30
• Completion: 2020-06-30
• First posted: 2020-03-19
• Last updated: 2021-06-18

Locations

1 site across 1 country: Dominican Republic