NCT04152226

A Trial to Evaluate the Safety and and Tolerability of DBI-001 in Patients With Tinea Pedis

Clinical Study Protocol Number DBI-201- Open Label, Single-dose, Dose Escalating Evaluation of the Safety and Tolerability of DBI-001 in Patients With Tinea Pedis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: DermBiont, Inc. · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, single-dose, dose escalating evaluation of the safety and tolerability of three dose levels of DBI-001 in patients with Tinea pedis. The purpose of the current protocol is to establish the safety and tolerability of a single application of J. lividum to the feet of patients with proven T. pedis. In addition, the effect of J. lividum on the T. pedis will also be evaluated.

Detailed description

Open-label, single-dose, dose escalating evaluation of the safety and tolerability of three dose levels of DBI-001 in patients with Tinea pedis. The test product will be applied by study personnel at the investigational site. Each subject will have a single application of approximately 0.5 ml of the test article applied to each foot. Both affected and unaffected feet will be treated covering the web spaces, toes, toe nails as well as the plantar and lateral aspect of both feet. Each of the three groups will have 4 subjects. After the first cohort has completed their day 7 visits, if no significant tolerability or safety issues identified the second cohort will be enrolled. After the second cohort has completed the day 7 visits and if no significant tolerability of safety issues is identified the third cohort will be enrolled.

Conditions

• Tinea Pedis

Interventions

Type	Name	Description
DRUG	Janthinobacterium lividum	Investigational Product

Timeline

• Start date: 2019-02-19
• Primary completion: 2019-04-30
• Completion: 2019-04-30
• First posted: 2019-11-05
• Last updated: 2025-06-17
• Results posted: 2025-06-17

Locations

1 site across 1 country: Dominican Republic