Ignite Creation Date:
2025-12-26 @ 5:22 PM
Ignite Modification Date:
2026-03-04 @ 8:33 AM
Study NCT ID:
NCT04080206
Status:
COMPLETED
Last Update Posted:
2021-05-10
First Post:
2019-09-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Safety Study of 188-0551 Spray Versus Reference Listed Drug (RLD) in Adult Subjects With Plaque Psoriasis
Sponsor:
Therapeutics, Inc.
Organization:
Study Overview
Official Title:
An Open Label, Comparative Evaluation of the Adrenal Suppression Potential and Pharmacokinetic Properties of 188-0551 Spray Versus Reference Listed Drug (RLD) Applied Every 12 Hours for 2 Weeks in Subjects With Moderate to Severe Plaque Psoriasis
Status:
COMPLETED
Status Verified Date:
2021-05
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:
Adrenal suppression effects of corticosteroids are among the most important safety concerns for this group of products. This study is to determine and compare the adrenal suppression potential and the pharmacokinetic (PK) properties of 188-0551 Spray versus an FDA-approved drug (also known as a "Reference Listed Drug" \[RLD\]) under maximal use conditions when applied twice daily (approximately every 12 hours) in adult subjects with stable, moderate to severe, plaque psoriasis.
Detailed Description:
None
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?: