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