Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06363461
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-30
First Post:
2024-04-03
Brief Title:
Study of TDM-180935 in Atopic Dermatitis Patients
Sponsor:
Technoderma Medicines Inc
Organization:
Technoderma Medicines Inc
Study Overview
Official Title:
A Randomized Vehicle-Controlled Parallel Group Study of Topical TDM-180935 to Evaluate the Preliminary Efficacy Safety Tolerability and Pharmacokinetics in Atopic Dermatitis Patients
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
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:
None
Brief Summary:
Randomized Vehicle-controlled Parallel Group Study of TDM-180935 in Atopic Dermatitis Patients
Detailed Description:
Protocol 239-13851-202 is a Phase 2a study entitled A Randomized Vehicle-Controlled Parallel Group Study of Topical TDM-180935 to Evaluate the Preliminary Efficacy Safety Tolerability and Pharmacokinetics in Atopic Dermatitis Patients Eligible subjects 24 in the randomized portion of the study will be randomized 2211 to 1 of the 4 groups low dose vs high dose vs placebo 1 vs placebo 2 and treated for 8 weeks Eligible subjects 6 in the PK pharmacokinetics cohort will be treated with the high dose in an open label fashion
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