Ignite Creation Date:
2024-05-06 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 12:55 PM
Study NCT ID:
NCT03688464
Status:
WITHDRAWN
Last Update Posted:
2023-08-15
First Post:
2018-09-26
Brief Title:
Treatment of Nighttime Pruritus in Atopic Dermatitis
Sponsor:
University of Nebraska
Organization:
University of Nebraska
Study Overview
Official Title:
Efficacy of Melatonin and Diphenhydramine Versus Placebo in Treatment of Nighttime Pruritus in Atopic Dermatitis
Status:
WITHDRAWN
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study never started
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will look at melatonin vs first generation antihistamine vs placebo in improving nighttime itching in children with atopic dermatitis
Detailed Description:
This will be a 6 week study to determine the efficacy of melatonin vs first generation antihistamine vs placebo in improving nighttime pruritus in children with atopic dermatitis
Secondary aims will include
1 Determine efficacy of melatonin vs first generation antihistamine in management of sleep disturbance in children with atopic dermatitis
2 Compare differences between treatment groups in disease improvement
3 Compare differences between treatment groups in quality of life
Secondary aims will include
1 Determine efficacy of melatonin vs first generation antihistamine in management of sleep disturbance in children with atopic dermatitis
2 Compare differences between treatment groups in disease improvement
3 Compare differences between treatment groups in quality of life
Study Oversight
Has Oversight DMC:
None
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?:
True
Is an FDA AA801 Violation?:
None