nctId: NCT06363461 id: 239-13851-202 briefTitle: Study of TDM-180935 in Atopic Dermatitis Patients overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-09-30 date: 2024-10-31 date: 2024-04-12 date: 2024-04-12 name: Technoderma Medicines Inc. class: INDUSTRY name: Therapeutics, Inc. briefSummary: Randomized, Vehicle-controlled, Parallel Group Study of TDM-180935 in Atopic Dermatitis Patients conditions: Atopic Dermatitis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 24 type: ESTIMATED name: TDM-180935 topical ointment 1.0% name: TDM-180935 topical ointment 2.0% name: TDM-180935 topical vehicle ointment 1 name: TDM-180935 topical vehicle ointment 2 measure: Change in m-EASI (modified Eczema Area and Severity Index) score measure: Proportion of patients with a ≥ 2 point improvement in vIGA-AD score (validated Investigator's Global Assessment for Atopic Dermatitis score) measure: Change in m-EASI (modified Eczema Area and Severity Index) score measure: Proportion of patients with a 50% improvement in m-EASI (modified Eczema Area and Severity Index) score measure: Proportion of patients with a 75% improvement in m-EASI (modified Eczema Area and Severity Index) score measure: Proportion of patients with a 90% improvement in m-EASI (modified Eczema Area and Severity Index) score measure: Change in BSA (body surface area) affected measure: Proportion of patients with a 4-point improvement from Baseline in WI-NRS (Worst Itch-Numeric Rating Scale) score measure: Incidence (severity and causality) of any local and systemic AEs (adverse events) measure: Number of patients with presence (and severity) of the following LSRs (local skin reactions): skin pigmentation (hyperpigmentation and hypopigmentation), edema, erosion,scaling, and burning/stinging measure: Changes from Baseline in vital signs (temperature) measure: Changes from Baseline in vital signs (systolic and diastolic blood pressure) measure: Changes from Baseline in vital signs (heart rate) measure: Changes from Baseline in vital signs (respiration rate) measure: Changes from baseline in clinical laboratory tests (including Blood Chemistries, Hematology, and Urinalysis) measure: Number of participants with abnormal ECG readings sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Site 3 city: Rolling Meadows state: Illinois zip: 60008 country: United States lat: 42.08419 lon: -88.01313 facility: Site 7 city: Covington state: Louisiana zip: 70433 country: United States lat: 30.47549 lon: -90.10042 facility: Site 5 city: New Brighton state: Minnesota zip: 55112 country: United States lat: 45.06552 lon: -93.20189 facility: Site 6 city: Anderson state: South Carolina zip: 29621 country: United States lat: 34.50344 lon: -82.65013 facility: Site 1 city: Austin state: Texas zip: 78759 country: United States lat: 30.26715 lon: -97.74306 facility: Site 4 city: College Station state: Texas zip: 77845 country: United States lat: 30.62798 lon: -96.33441 facility: Site 2 city: Norfolk state: Virginia zip: 23502 country: United States lat: 36.84681 lon: -76.28522 hasResults: False