A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase Ib/II Clinical Study to Evaluate the Safety and Efficacy of HL-300 Ointment in Patients With Mild-to-Moderate Atopic Dermatitis
This study is a randomized, double-blind, placebo-controlled, multicenter Phase Ib/II clinical study designed to evaluate the efficacy, safety, and PK characteristics of HL-300 ointment with different concentration regimens for mild-to-moderate AD.
• Age ≥18 years and ≤75 years at the time of ICF signing, with no gender restriction
• Meeting the Hanifin \& Rajka diagnostic criteria for atopic dermatitis (AD) at screening, with a history of AD ≥ 6 months before screening, and the AD condition judged by the investigator to be stable within 4 weeks prior to ICF signing,.
• vIGA-AD score of 2-3 at screening and baseline visits;
• EASI score within the range of 5-21 at screening and baseline;
• Body Surface Area (BSA) affected by AD skin lesions meeting one of the following requirements at screening and baseline visits, with skin lesions suitable for topical treatment:
⁃ Cohort 1: BSA of 5% to 20%;
• Women of childbearing potential and men willing to use at least one highly effective method of contraception or practice abstinence from the time of informed consent signing until 3 months after the last dose of the investigational product
• Those who voluntarily participate in the study and sign the informed consent form