Ignite Creation Date:
2024-05-06 @ 2:34 AM
Last Modification Date:
2024-10-26 @ 11:20 AM
Study NCT ID:
NCT02075632
Status:
COMPLETED
Last Update Posted:
2014-09-05
First Post:
2014-01-28
Brief Title:
Study to Evaluate Product Duration of Use Experience With Alclometasone Dipropionate Cream
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Mult-Center Open-Label Study to Evaluate Product Duration of Use Experience With Aclometasone Diproprionate Cream
Status:
COMPLETED
Status Verified Date:
2014-08
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 multi-center open-label study to evaluate whether participants follow the duration of use instructions for short-term use of alclometasone dipropionate in a population of participants with itchy skin conditions who would use OTC treatments for relief The study population will be composed of two different cohorts chronic condition sufferers eczema or psoriasis and participants who suffer from occasional itchy skin experiences such as poison ivy oak sumac insect bites or skin irritations due to jewelry cosmetics detergents or soaps where an anti-itch medication would be used
Detailed Description:
Approximately 313 participants who are currently suffering from an itchy skin condition caused by eczema or psoriasis or any occasional itchy skin experiences will be enrolled into the study to get 250 participants who complete the study at least 100 to each of the cohorts After evaluation of the study criteria the site staff will dispense product and a diary card to the subject to use over the next 14 days At the end of the 14 days each participant will come to the research site to return the remaining product and undergo the study termination interview with the Concentrics nurse via telephone The study will be conducted in approximately 15 research sites located throughout the United States US
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None