Atopic Dermatitis (AD)
Conditions
Keywords
Roflumilast cream, Atopic dermatitis
Brief summary
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.
Detailed 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.
Interventions
Roflumilast cream 0.15% is applied once daily for 4 weeks
DRUGVehicle cream
Vehicle cream is applied once daily for 4 weeks
Sponsors
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of subjects with vIGA-AD success | Baseline, week 4 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of subjects with vIGA-AD of clear or almost clear | Baseline, week 4 | 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). |
| In subjects with WI-NRS ≥ 4 at baseline, percentage of subjects with ≥ 4 point reduction in WI-NRS | Baseline, week 4 | 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). |
| In subjects with moderate AD severity (vIGA-AD score of 3) at baseline, percentage of subjects with vIGA-AD success | Baseline, week 4 | 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). |
| Safety: treatment emergence adverse events | Up to 4 weeks | Incidence, severity, and causal relationship of treatment emergence adverse events (TEAE), TEAEs leading to withdrawal and death. |
| Trough concentration (Ctrough) | Week 2, week 4 | Trough concentration of plasma roflumilast and its N-oxide |
| Percentage of subjects with at least 75% reduction in the Eczema Area and Severity Index (EASI-75) | Baseline, week 4 | 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. |
Countries
China
Outcome results
None listed