Efficacy and Safety of Roflumilast Cream in Subjects With Atopic Dermatitis

Hangzhou Zhongmei Huadong Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Atopic Dermatitis (AD)

Treatments: Drug: Vehicle cream; Drug: Roflumilast Cream 0.15%

Study type: Interventional

Funder types: Industry

Identifiers

NCT06631170

HDM3014-2-301

Details and patient eligibility

About

This study will assess the safety and efficacy of Roflumilast cream versus vehicle applied once a day for 4 weeks by subjects with atopic dermatitis.

Full description

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.

Enrollment: 354 patients

Sex: All

Ages: 6+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female subjects aged ≥ 6 years at screening.
2. 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.
3. Have stable disease for the past 4 weeks prior to screening.
4. Have mild or moderate AD at baseline.
5. Have BSA affected by AD of 3%-20% at baseline.
6. 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.
7. Being in good health as judged by the Investigator.
8. Subjects voluntarily participate in the study and sign the ICF before the start of study-related activities.

Exclusion criteria

1. 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.
2. Previous treatment with roflumilast cream.
3. 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.
4. Use of topical treatments that affect the efficacy assessment of AD 2 weeks prior to the first dose.
5. Use of phototherapy, tanning beds, or any other light-emitting devices within 4 weeks prior to the first dose.
6. Female subjects who are pregnant or breastfeeding, or plan to become pregnant or breastfeed during the study.
7. Subjects with a history of chronic alcohol or drug abuse within 6 months prior to Screening.
8. 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.
9. 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

354 participants in 2 patient groups, including a placebo group

Roflumilast cream 0.15%

Experimental group

Description:

Active comparator

Treatment:

Drug: Roflumilast Cream 0.15%

Vehicle cream

Placebo Comparator group

Description:

Placebo comparator

Treatment:

Drug: Vehicle cream