Ignite Creation Date:
2024-05-06 @ 8:09 AM
Last Modification Date:
2024-10-26 @ 11:56 AM
Study NCT ID:
NCT02677636
Status:
WITHDRAWN
Last Update Posted:
2016-09-09
First Post:
2016-01-27
Brief Title:
Efficacy and Safety Study of MSRD-100 in Subjects With Atopic Dermatitis 3 Months of Age and Older
Sponsor:
Merz North America Inc
Organization:
Merz North America Inc
Study Overview
Official Title:
A Phase 3 Double-Blind Randomized Vehicle-Controlled Multicenter Parallel Group Evaluation of the Efficacy and Safety of MSRD-100 in Subjects 3 Months of Age With Atopic Dermatitis
Status:
WITHDRAWN
Status Verified Date:
2016-09
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:
MSRD-100
Brief Summary:
This is a double-blind randomized vehicle-controlled multi-center parallel group Phase 3 study of MSRD-100 in the treatment of atopic dermatitis in subjects aged 3 months and up
Detailed Description:
This is a 4-week efficacy safety and tolerability study of MSRD-100 applied twice daily for 4 weeks compared to its vehicle among subjects 3 months of age in the treatment of atopic dermatitis covering 5 body surface area
The study will consist of up to 4 visits which includes Screening - Visit 1 Screening Baseline - Visit 2 Visit 3 Day 14 and an End of TreatmentFinal Study Visit - Visit 4 Day 28
Study IDs M169981001 and M169981002 are two identical studies being run in parallel with different study sites
The study will consist of up to 4 visits which includes Screening - Visit 1 Screening Baseline - Visit 2 Visit 3 Day 14 and an End of TreatmentFinal Study Visit - Visit 4 Day 28
Study IDs M169981001 and M169981002 are two identical studies being run in parallel with different study sites
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