Ignite Creation Date:
2024-05-06 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 12:54 PM
Study NCT ID:
NCT03680131
Status:
UNKNOWN
Last Update Posted:
2022-09-13
First Post:
2018-09-19
Brief Title:
Evaluation of EB01 Cream for the Treatment of Chronic Allergic Contact Dermatitis
Sponsor:
Edesa Biotech Inc
Organization:
Edesa Biotech Inc
Study Overview
Official Title:
A Randomized Double-Blind Vehicle-Controlled Sample Size Adaptive Design Study to Evaluate the Safety and Efficacy of Topically Applied EB01 Cream in Healthy Adult Volunteers and Adult Subjects With Chronic Allergic Contact Dermatitis
Status:
UNKNOWN
Status Verified Date:
2022-09
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
The purpose of this study is to evaluate the safety and efficacy of EB01 Cream 02 10 20 applied twice per day BID for the treatment of moderate to severe chronic allergic contact dermatitis ACD
The purpose of the open label extension is to assess the long-term safety tolerability and efficacy of EB01 20 cream in subjects with moderate to severe chronic allergic contact dermatitis
The purpose of the open label extension is to assess the long-term safety tolerability and efficacy of EB01 20 cream in subjects with moderate to severe chronic allergic contact dermatitis
Detailed Description:
None
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?:
None
Is an FDA AA801 Violation?:
None