Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2026-01-09 @ 9:23 AM
Study NCT ID:
NCT03824405
Status:
COMPLETED
Last Update Posted:
2022-10-25
First Post:
2019-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of the Safety, Tolerability and Efficacy of BTX 1204 in Patients With Moderate Atopic Dermatitis
Sponsor:
Botanix Pharmaceuticals
Organization:
Study Overview
Official Title:
A Randomized, Double-Blind, Vehicle-Controlled Study of the Safety, Tolerability and Efficacy of BTX 1204 in Patients With Moderate Atopic Dermatitis
Status:
COMPLETED
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a randomized, double-blind, vehicle-controlled, Phase 2 study in subjects with moderate AD.
Detailed Description:
This is a randomized, double-blind, vehicle-controlled, Phase 2 study in subjects with moderate AD. Eligible subjects will be enrolled and randomized to treatment with BTX 1204 or Vehicle for 84 days. Approximately two hundred (200) subjects will be enrolled. Subjects will receive BID application of study drug for 84 days with a final application on the evening of Day 84 for a total of 168 doses.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
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?: