Ignite Creation Date:
2024-05-06 @ 2:02 PM
Last Modification Date:
2024-10-26 @ 1:23 PM
Study NCT ID:
NCT04192513
Status:
TERMINATED
Last Update Posted:
2021-06-18
First Post:
2019-12-02
Brief Title:
Observer-Blinded Dose Escalating Single Dose to Study Safety and Antimicrobial Efficacy of Gel vs Placebo
Sponsor:
DermBiont Inc
Organization:
DermBiont Inc
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Covid-19 has shut the clinic indefinitely
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None