A Phase 3 interventional study of Roflumilast Cream 0.15% and Vehicle cream in Atopic Dermatitis (AD), sponsored by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.. Completed at 61 sites in China. Open to participants aged 6 Years and older. Per ClinicalTrials.gov, last updated 2025-09-02.
Sponsored by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. · Phase 3, Interventional, and Treatment
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.
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.
1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.
This study's enrollment of 354 is above the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. is the lead sponsor of 49 studies on the registry; 38 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Active comparator
Drug: Roflumilast Cream 0.15%
Placebo comparator
Drug: Vehicle cream
Roflumilast cream 0.15% is applied once daily for 4 weeks
Vehicle cream is applied once daily for 4 weeks
Percentage of subjects with vIGA-AD success
The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (reported only in integers of 0 to 4 where 0 is clear). IGA sucess is defined as a vIGA-AD score of 'clear' or 'almost clear' plus at least 2-grade improvement from baseline
Time frame: Baseline, week 4
In subjects with moderate AD severity (vIGA-AD score of 3) at baseline, percentage of subjects with vIGA-AD success
The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (reported only in integers of 0 to 4 where 0 is clear).
Time frame: Baseline, week 4
Percentage of subjects with vIGA-AD of "clear" or "almost clear"
The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (reported only in integers of 0 to 4 where 0 is clear).
Time frame: Baseline, week 4
In subjects with WI-NRS ≥ 4 at baseline, percentage of subjects with ≥ 4 point reduction in WI-NRS
The Worst Itch Numerical Rating Scale (WI-NRS) will be determined by the subject's recording of daily assessment of worst itch over the past 24 hours. The scale is from '0 to 10' ("no itch" to "worst itch imaginable" or "worst imaginable itch").
Time frame: Baseline, week 4
Percentage of subjects with at least 75% reduction in the Eczema Area and Severity Index (EASI-75)
EASI combines the assessment of the severity of lesions and the area affected into a single total score in the range 0 (no disease) to 72 (maximal disease). Four anatomic sites-head, upper extremities, trunk, and lower extremities-are assessed for erythema, induration/infiltration (papules), excoriation, and lichenification as seen on the day of the examination. To calculate the EASI, the sum of the severity rating (0 to 3 with 3 being the most severe) for four clinical signs are multiplied with the numerical value of the area affected and with the percentage of the four body areas.
Time frame: Baseline, week 4
Safety: treatment emergence adverse events
Incidence, severity, and causal relationship of treatment emergence adverse events (TEAE), TEAEs leading to withdrawal and death.
Time frame: Up to 4 weeks
Trough concentration (Ctrough)
Trough concentration of plasma roflumilast and its N-oxide
Time frame: Week 2, week 4
Plan to share: No
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This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.