Ignite Creation Date:
2024-07-17 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06487000
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-06-27
Brief Title:
To Determine the Dose-dependent Efficacy and Safety of EC-18 in Patients With Moderate or Severe Atopic Dermatitis
Sponsor:
Enzychem Lifesciences Corporation
Organization:
Enzychem Lifesciences Corporation
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Parallel-group Multi-Center Phase 2 Clinical Trial to Evaluate Efficacy and Safety of EC-18 in Moderate to Severe Atopic Dermatitis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
To evaluate the efficacy and safety of oral administration of dose-dependent EC-18 for 16 weeks in patients with moderate to severe atopic dermatitis
Detailed Description:
This study will utilize a randomized double blind placebo-controlled parallel-group multi-Center design The Experimental group 1 will receive 1000mg of EC-182 capsules of EC-18 500mg 2 capsules of placebo The experimental group 2 will receive 2000mg of EC-18 4 capsules of EC-18 The placebo group will receive 4 capsules of placebo The time frame of this clinical trial will consist 16 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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?:
None