Efficacy and Safety of Roflumilast Cream in Subjects With Atopic Dermatitis

This is a parallel group, double blind, vehicle-controlled study in which Roflumilast cream or vehicle is applied once daily for 4 weeks to subjects with mild or moderate atopic dermatitis.

Inclusion criteria

• Male or female subjects aged ≥ 6 years at screening.
• Diagnosed with atopic dermatitis (AD) for at least 6 months for subjects aged ≥18 years and 3 months for subjects aged 6~17 years at screening.
• Have stable disease for the past 4 weeks prior to screening.
• Have mild or moderate AD at baseline.
• Have BSA affected by AD of 3%-20% at baseline.
• Women of childbearing potential (WOCBP) have a negative pregnancy blood test at screening and a negative urine pregnancy test at baseline. WOCBP must have taken and agree to continue taking highly effective contraceptive measures from 4 weeks before the first dose to 2 months after the last dose.
• Being in good health as judged by the Investigator.
• Subjects voluntarily participate in the study and sign the ICF before the start of study-related activities.

Exclusion criteria

• Subjects with any serious medical condition or clinically significant abnormality that would prevent study participation or place the subject at significant risk, as judged by the Investigator.
• Previous treatment with roflumilast cream.
• Use of systemic treatments that affect the efficacy assessment of AD 4 weeks or 5 half-lives (whichever is longer) prior to the first dose.
• Use of topical treatments that affect the efficacy assessment of AD 2 weeks prior to the first dose.
• Use of phototherapy, tanning beds, or any other light-emitting devices within 4 weeks prior to the first dose.
• Female subjects who are pregnant or breastfeeding, or plan to become pregnant or breastfeed during the study.
• Subjects with a history of chronic alcohol or drug abuse within 6 months prior to Screening.
• Subjects who are family members of the clinical study site, clinical study staff, or sponsor, or family members of enrolled subjects living in the same house.
• Subjects/legal guardians who are unable to communicate, understand the study, or other situations deemed inappropriate for participation in a clinical trial by the investigator.