NCT04192513

Observer-Blinded Dose Escalating, Single Dose to Study Safety and Antimicrobial Efficacy of Gel vs. Placebo

A Randomized, Observer-Blinded, Vehicle Controlled, Single Dose, Dose Escalating, Single Application Within-patient Bilateral Comparison to Study the Safety and Antimicrobial Efficacy of DBI-001 Gel Vs. Placebo

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: DermBiont, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

A Randomized, Observer-Blinded, Vehicle Controlled, Single Dose, Dose Escalating, Single Application Within-patient Bilateral Comparison. The goal is to determine the safety and tolerability of DBI-001 Gel vs. Placebo in Adults with Atopic Dermatitis (AD).

Detailed description

A Randomized, Observer-Blinded, Vehicle Controlled, Single Dose, Dose Escalating, Single Application Within-patient Bilateral Comparison. The goal is to determine the safety and tolerability of DBI-001 Gel vs. Placebo in Adults with Atopic Dermatitis and to determine the antibacterial effect of a single application of DBI-001 Gel on the abundance of S. aureus. Tolerability will be evaluated through assessment of disease state severity and signs and symptoms of local tolerability (pain / burning / stinging, pruritus, erythema, edema, and scabbing / crusting) and review of adverse events. Any local skin reaction that requires use of a concomitant therapy or study discontinuation will be reported.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	J. lividum	Investigational Product

Timeline

• Start date: 2019-05-20
• Primary completion: 2020-06-30
• Completion: 2020-06-30
• First posted: 2019-12-10
• Last updated: 2021-06-18

Locations

1 site across 1 country: Dominican Republic