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

Atopic Dermatitis Clinical Trial

Official title:
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

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04192513
Study type Interventional
Source DermBiont, Inc.
Contact
Status Terminated
Phase Phase 2
Start date May 20, 2019
Completion date June 30, 2020
View Details
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