Ignite Creation Date:
2025-12-24 @ 12:19 PM
Ignite Modification Date:
2025-12-27 @ 4:06 PM
Study NCT ID:
NCT06363461
Status:
COMPLETED
Last Update Posted:
2025-04-24
First Post:
2024-04-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of TDM-180935 in Atopic Dermatitis Patients
Sponsor:
Technoderma Medicines Inc.
Organization:
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:
COMPLETED
Status Verified Date:
2025-04
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 (2:2:1:1) 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:
True
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?: