HL-300 Ointment in Patients With Mild-to-Moderate Atopic Dermatitis

In the study, it is planned to enroll approximately 148‐156 trial participants, dividedinto two cohorts. Cohort 1: a randomized, double‐blind, placebo‐parallel controlled studydesign, planning to enroll 140 trial participants, randomized in a 1:1:1:1 ratio to thestudy group or placebo group, with baseline disease severity (mild [vIGA‐AD = 2] andmoderate [vIGA‐AD = 3]) set as stratification factors to ensure balanced participantstatus across groups. Cohort 2: an open‐label, intensive sampling design, planning toenroll 8 trial participants for each dosage strength, enrolled separately, withcontinuous dosing for 8 days.The study includes a screening period, a treatment period, and a follow‐up period. Thequality management system for this trial aims to prospectively integrate quality bydesign into all aspects of the trial to ensure the rights and interests, safety, andwell‐being of trial participants, and to guarantee the reliability of the generated dataand the scientific validity of the trial results. This system strictly adheres to theprinciples of ICH E6(R3) and ICH E8(R1), employing a risk‐based and proportionateapproach.During the trial design phase, the investigators have systematically identified thecritical to quality (CtQ) factors for ensuring the quality of this trial. Given the knownsafety profile of JAK inhibitors (e.g., infections, hematologic abnormalities, hepaticand renal function effects, thrombosis, etc.), the CtQ factors for this trial willspecifically focus on: ‐ Trial participant safety: Identification, recording, assessment, and timelyreporting of Adverse Events (AEs) and Serious Adverse Events (SAEs). ‐ Key efficacy data: Accuracy and integrity of data collection related to the primaryand secondary endpoints of the trial (e.g., vIGA‐AD, EASI, BSA, WI‐NRS, DLQI,SCORAD, etc.). ‐ Critical processes: Strict adherence to inclusion/exclusion criteria duringparticipant screening [e.g., exclusion of severe infections (including herpeszoster, tuberculosis, and other opportunistic infections) and active infections,hematologic toxicity (anemia, neutropenia), elevated transaminases, and high‐riskthrombosis population], protocol‐mandated laboratory tests (e.g., blood routine,blood biochemistry, urinalysis, coagulation function, etc.), completeness ofrandomization and blinding, concomitant medication management (e.g.,contraindications for topical medications for AD or AD‐related skin infections,systemic treatments for AD, systemic immunosuppressants or immunomodulators, otherJAK inhibitors, etc.), rules for suspension/termination of dosing.