NCT06363461

Study of TDM-180935 in Atopic Dermatitis Patients

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Technoderma Medicines Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	TDM-180935 topical ointment 1.0%	TDM-180935 topical ointment 1.0%
DRUG	TDM-180935 topical ointment 2.0%	TDM-180935 topical ointment 2.0%
DRUG	TDM-180935 topical vehicle ointment 1	TDM-180935 topical vehicle ointment 1
DRUG	TDM-180935 topical vehicle ointment 2	TDM-180935 topical vehicle ointment 2

Timeline

• Start date: 2024-04-13
• Primary completion: 2025-03-08
• Completion: 2025-04-08
• First posted: 2024-04-12
• Last updated: 2025-04-24

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study