Atopic Dermatitis Eczema
Conditions
Brief summary
This study was a Phase 3, multicenter, open-label extension study of the long-term safety of roflumilast cream 0.15% (completers of studies ARQ-151-311 or ARQ-151-312 aged ≥6 years and ARQ-151-315 rollovers who turned 6 years of age on study) or roflumilast cream 0.05% (ARQ-151-315 rollovers aged 2 to 5 years). Participants with mild to moderate atopic dermatitis (AD) applied roflumilast cream once daily (qd) for up to 52 weeks.
Interventions
DRUGARQ-151 Cream 0.15% or ARQ-151 Cream 0.05%
ARQ-151 Cream 0.15% or ARQ-151 Cream 0.05%
Sponsors
Arcutis Biotherapeutics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. For adult subjects: Participants legally competent to sign and give informed consent. For pediatric and adolescent subjects: Informed consent of parent(s) or legal guardian, and, if age appropriate, assent by the subjects, as required by local laws. 2. Males and females, ages 2 years and older. (Only subjects 18 years and older will be enrolled at sites located in the province of Québec in Canada.) 3. Subjects with atopic dermatitis who met eligibility criteria for and successfully completed one of three preceding studies through Week 4, and are able and eligible to enroll into this long-term safety study on the Week 4 visit of the preceding study. 4. Females of childbearing potential (FOCBP) must have a negative urine pregnancy test at all study visits. In addition, sexually active FOCBP must agree to use at least one form of a highly effective or barrier method of contraception throughout the trial. 5. Females of non-childbearing potential should either be pre-menarchal, or post-menopausal with spontaneous amenorrhea for at least 12 months (post-menopausal status would have been confirmed with FSH testing in the preceding study) or have undergone surgical sterilization (permanent sterilization methods include hysterectomy, bilateral oophorectomy, or bilateral salpingectomy). 6. Subjects and parent(s)/legal guardian(s) are considered reliable and capable of adhering to the Protocol and visit schedule, according to the judgment of the Investigator.
Exclusion criteria
1. Subjects who experienced a treatment-related AE or a serious AE (SAE) that precluded further treatment with ARQ-151 cream in the preceding study. 2. Subjects that use any Excluded Medications and Treatments. 3. Subjects with skin conditions other than AD that would interfere with evaluations of the effect of the study medication on AD, as determined by the Investigator. Subjects with any condition on the treatment area which, in the opinion of the Investigator, could confound efficacy measurements. 4. Subjects with known genetic dermatological conditions that overlap with AD. 5. Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding. 6. Subjects and parent(s)/legal guardian(s) who are unable to communicate, read or understand the local language(s), or who display another condition, which in the Investigator's opinion, makes them unsuitable for clinical study participation. 7. Subjects who are family members of the clinical study site, clinical study staff, or sponsor, or family members of enrolled subjects (subjects enrolled in other studies of ARQ-151 cream) living in the same house.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With ≥1 Treatment-emergent Adverse Event (TEAE) | Up to 52 weeks | The number of participants with ≥1 TEAE(s) is reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Validated Investigator Global Assessment-Atopic Dermatitis (vIGA-AD) Score of 0 or 1 at Each Assessment | Weeks 4, 12, 24, 36, and 52 | 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 as score of 0 'clear' to 4 'severe' ), with lower scores indicating reduced symptom severity and vice versa. Multiple imputation was used to handle missing data up to Week 24 or 52 for 24- and 52-week cohorts. |
| Percentage of Participants With vIGA-AD Success | Weeks 4, 12, 24, 36, and 52 | The percentage of participants with vIGA-AD success is presented. Success is defined as vIGA-AD value of 0 or 1 plus a 2-grade improvement from baseline. Multiple imputation was used to handle missing data up to Week 24 or 52 for 24- and 52-week cohorts. |
| Change From Baseline in Worst Itch-Numeric Rating Scale (WI-NRS) Score Over Time in Participants ≥12 Years of Age in Parent Study | Weeks 4, 12, 24, 36, and 52 | Change from baseline in WI-NRS score is reported. WI-NRS is a subject-reported severity of itch at its highest intensity during the previous 24-hour period. The scale is from '0 to 10' (no itch to worst imaginable itch), with lower scores indicating reduced symptom severity and vice versa. |
| Percent Change From Baseline in EASI Score | Weeks 4, 12, 24, 36, and 52 | EASI is an instrument to measure the severity and extent of AD. The body is first divided into 4 areas: head (10% of skin), arms (20%), trunk (30%), and legs (40%). Then, the area affected is scored from 0 (0% involvement) to 6 (90%-100% involvement), and severity is scored from 0 ('none') to 3 ('severe'). EASI combines the area affected and severity ratings to get a final composite score ranging from 0 (no disease) to 72 (severe disease). Note that palms and soles were treated as appropriate but were not counted towards any measurements of EASI. |
Countries
Canada, United States
Participant flow
Recruitment details
Participants were rolled over upon completion of parent studies ARQ-151-311 (NCT04773587), ARQ-151-312 (NCT03638258), and ARQ-151-315 (NCT04845620). Rollovers from 311/312 were analyzed separately from 315 rollovers.
Pre-assignment details
Participants with atopic dermatitis were enrolled at 153 sites in the United States (US), Canada, and Poland.
Participants by arm
| Arm | Count |
|---|---|
| ARQ-151-311/312: RC/RC 0.15% Group Participants who received roflumilast cream 0.15% in parent studies received roflumilast 0.15% cream qd for up to 52 weeks in the present study. | 439 |
| ARQ-151-311/312: VC/RC 0.15% Group Participants who received vehicle cream in the parent studies received roflumilast 0.15% cream qd for up to 52 weeks in the present study. | 218 |
| ARQ-151-315: RC/RC 0.05% or 0.15% Group Participants who received roflumilast cream 0.05% or 0.15% in the parent study received roflumilast 0.15% cream qd for up to 52 weeks in the present study. Participants received 0.05% until the first study visit after turning 6 years of age, and were then switched to 0.15%. | 382 |
| ARQ-151-315: VC/RC 0.05% or 0.15% Group Participants who received vehicle cream in the parent study received roflumilast 0.05% or 0.15% cream qd for up to 52 weeks in the present study. Participants received 0.05% until the first study visit after turning 6 years of age, and were then switched to 0.15%. | 180 |
| Total | 1,219 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 10 | 10 | 10 | 7 |
| Overall Study | Lack of Efficacy | 28 | 11 | 37 | 8 |
| Overall Study | Lost to Follow-up | 47 | 21 | 30 | 17 |
| Overall Study | Miscellaneous | 7 | 3 | 4 | 2 |
| Overall Study | Non-compliance | 8 | 3 | 5 | 1 |
| Overall Study | Physician Decision | 3 | 0 | 5 | 0 |
| Overall Study | Protocol Violation | 1 | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 46 | 26 | 37 | 21 |
Baseline characteristics
| Characteristic | Total | ARQ-151-311/312: RC/RC 0.15% Group | ARQ-151-311/312: VC/RC 0.15% Group | ARQ-151-315: RC/RC 0.05% or 0.15% Group | ARQ-151-315: VC/RC 0.05% or 0.15% Group |
|---|---|---|---|---|---|
| Age, Continuous | 12.2 years STANDARD_DEVIATION 14.9 | 19.4 years STANDARD_DEVIATION 16.4 | 20.5 years STANDARD_DEVIATION 17.9 | 3.4 years STANDARD_DEVIATION 1.11 | 3.4 years STANDARD_DEVIATION 1.17 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 204 Participants | 75 Participants | 34 Participants | 70 Participants | 25 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1008 Participants | 361 Participants | 182 Participants | 310 Participants | 155 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 7 Participants | 3 Participants | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 8 Participants | 6 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 143 Participants | 63 Participants | 35 Participants | 30 Participants | 15 Participants |
| Race (NIH/OMB) Black or African American | 169 Participants | 58 Participants | 31 Participants | 58 Participants | 22 Participants |
| Race (NIH/OMB) More than one race | 55 Participants | 20 Participants | 7 Participants | 25 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 33 Participants | 19 Participants | 6 Participants | 6 Participants | 2 Participants |
| Race (NIH/OMB) White | 810 Participants | 272 Participants | 139 Participants | 262 Participants | 137 Participants |
| Sex: Female, Male Female | 642 Participants | 244 Participants | 122 Participants | 185 Participants | 91 Participants |
| Sex: Female, Male Male | 577 Participants | 195 Participants | 96 Participants | 197 Participants | 89 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 439 | 0 / 218 | 0 / 382 | 0 / 180 |
| other Total, other adverse events | 18 / 439 | 12 / 218 | 82 / 382 | 40 / 180 |
| serious Total, serious adverse events | 5 / 439 | 3 / 218 | 12 / 382 | 3 / 180 |
Outcome results
Primary
Number of Participants With ≥1 Treatment-emergent Adverse Event (TEAE)
The number of participants with ≥1 TEAE(s) is reported.
Time frame: Up to 52 weeks
Population: All treated participants are included.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ARQ-151-311/312: RC/RC 0.15% Group | Number of Participants With ≥1 Treatment-emergent Adverse Event (TEAE) | 151 Participants |
| ARQ-151-311/312: VC/RC 0.15% Group | Number of Participants With ≥1 Treatment-emergent Adverse Event (TEAE) | 90 Participants |
| ARQ-151-315: RC/RC 0.05% or 0.15% Group | Number of Participants With ≥1 Treatment-emergent Adverse Event (TEAE) | 189 Participants |
| ARQ-151-315: VC/RC 0.05% or 0.15% Group | Number of Participants With ≥1 Treatment-emergent Adverse Event (TEAE) | 91 Participants |
Secondary
Change From Baseline in Worst Itch-Numeric Rating Scale (WI-NRS) Score Over Time in Participants ≥12 Years of Age in Parent Study
Change from baseline in WI-NRS score is reported. WI-NRS is a subject-reported severity of itch at its highest intensity during the previous 24-hour period. The scale is from '0 to 10' (no itch to worst imaginable itch), with lower scores indicating reduced symptom severity and vice versa.
Time frame: Weeks 4, 12, 24, 36, and 52
Population: All randomized participants who were ≥12 years of age at the start of the parent studies are included.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ARQ-151-311/312: RC/RC 0.15% Group | Change From Baseline in Worst Itch-Numeric Rating Scale (WI-NRS) Score Over Time in Participants ≥12 Years of Age in Parent Study | Week 12 | -2.4 WI-NRS Score Change | Standard Deviation 3.06 |
| ARQ-151-311/312: RC/RC 0.15% Group | Change From Baseline in Worst Itch-Numeric Rating Scale (WI-NRS) Score Over Time in Participants ≥12 Years of Age in Parent Study | Week 36 | -2.6 WI-NRS Score Change | Standard Deviation 2.81 |
| ARQ-151-311/312: RC/RC 0.15% Group | Change From Baseline in Worst Itch-Numeric Rating Scale (WI-NRS) Score Over Time in Participants ≥12 Years of Age in Parent Study | Week 24 | -2.7 WI-NRS Score Change | Standard Deviation 2.85 |
| ARQ-151-311/312: RC/RC 0.15% Group | Change From Baseline in Worst Itch-Numeric Rating Scale (WI-NRS) Score Over Time in Participants ≥12 Years of Age in Parent Study | Week 52 | -3.2 WI-NRS Score Change | Standard Deviation 2.85 |
| ARQ-151-311/312: RC/RC 0.15% Group | Change From Baseline in Worst Itch-Numeric Rating Scale (WI-NRS) Score Over Time in Participants ≥12 Years of Age in Parent Study | Week 4 | -2.1 WI-NRS Score Change | Standard Deviation 2.8 |
| ARQ-151-311/312: VC/RC 0.15% Group | Change From Baseline in Worst Itch-Numeric Rating Scale (WI-NRS) Score Over Time in Participants ≥12 Years of Age in Parent Study | Week 52 | -1.2 WI-NRS Score Change | Standard Deviation 2.41 |
| ARQ-151-311/312: VC/RC 0.15% Group | Change From Baseline in Worst Itch-Numeric Rating Scale (WI-NRS) Score Over Time in Participants ≥12 Years of Age in Parent Study | Week 4 | -0.3 WI-NRS Score Change | Standard Deviation 2.23 |
| ARQ-151-311/312: VC/RC 0.15% Group | Change From Baseline in Worst Itch-Numeric Rating Scale (WI-NRS) Score Over Time in Participants ≥12 Years of Age in Parent Study | Week 12 | -0.2 WI-NRS Score Change | Standard Deviation 2.65 |
| ARQ-151-311/312: VC/RC 0.15% Group | Change From Baseline in Worst Itch-Numeric Rating Scale (WI-NRS) Score Over Time in Participants ≥12 Years of Age in Parent Study | Week 24 | -0.8 WI-NRS Score Change | Standard Deviation 2.69 |
| ARQ-151-311/312: VC/RC 0.15% Group | Change From Baseline in Worst Itch-Numeric Rating Scale (WI-NRS) Score Over Time in Participants ≥12 Years of Age in Parent Study | Week 36 | -0.3 WI-NRS Score Change | Standard Deviation 2.4 |
Secondary
Percentage of Participants With vIGA-AD Success
The percentage of participants with vIGA-AD success is presented. Success is defined as vIGA-AD value of 0 or 1 plus a 2-grade improvement from baseline. Multiple imputation was used to handle missing data up to Week 24 or 52 for 24- and 52-week cohorts.
Time frame: Weeks 4, 12, 24, 36, and 52
Population: All randomized participants are included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ARQ-151-311/312: RC/RC 0.15% Group | Percentage of Participants With vIGA-AD Success | Week 24 | 39.7 percentage of participants |
| ARQ-151-311/312: RC/RC 0.15% Group | Percentage of Participants With vIGA-AD Success | Week 12 | 33.7 percentage of participants |
| ARQ-151-311/312: RC/RC 0.15% Group | Percentage of Participants With vIGA-AD Success | Week 4 | 30.8 percentage of participants |
| ARQ-151-311/312: RC/RC 0.15% Group | Percentage of Participants With vIGA-AD Success | Week 52 | 42.7 percentage of participants |
| ARQ-151-311/312: RC/RC 0.15% Group | Percentage of Participants With vIGA-AD Success | Week 36 | 37.4 percentage of participants |
| ARQ-151-311/312: VC/RC 0.15% Group | Percentage of Participants With vIGA-AD Success | Week 24 | 21.6 percentage of participants |
| ARQ-151-311/312: VC/RC 0.15% Group | Percentage of Participants With vIGA-AD Success | Week 4 | 7.8 percentage of participants |
| ARQ-151-311/312: VC/RC 0.15% Group | Percentage of Participants With vIGA-AD Success | Week 12 | 15.8 percentage of participants |
| ARQ-151-311/312: VC/RC 0.15% Group | Percentage of Participants With vIGA-AD Success | Week 36 | 23.5 percentage of participants |
| ARQ-151-311/312: VC/RC 0.15% Group | Percentage of Participants With vIGA-AD Success | Week 52 | 24.2 percentage of participants |
| ARQ-151-315: RC/RC 0.05% or 0.15% Group | Percentage of Participants With vIGA-AD Success | Week 36 | 34.4 percentage of participants |
| ARQ-151-315: RC/RC 0.05% or 0.15% Group | Percentage of Participants With vIGA-AD Success | Week 4 | 28.7 percentage of participants |
| ARQ-151-315: RC/RC 0.05% or 0.15% Group | Percentage of Participants With vIGA-AD Success | Week 52 | 42.5 percentage of participants |
| ARQ-151-315: RC/RC 0.05% or 0.15% Group | Percentage of Participants With vIGA-AD Success | Week 12 | 29.5 percentage of participants |
| ARQ-151-315: RC/RC 0.05% or 0.15% Group | Percentage of Participants With vIGA-AD Success | Week 24 | 36.1 percentage of participants |
| ARQ-151-315: VC/RC 0.05% or 0.15% Group | Percentage of Participants With vIGA-AD Success | Week 12 | 24.9 percentage of participants |
| ARQ-151-315: VC/RC 0.05% or 0.15% Group | Percentage of Participants With vIGA-AD Success | Week 24 | 24.1 percentage of participants |
| ARQ-151-315: VC/RC 0.05% or 0.15% Group | Percentage of Participants With vIGA-AD Success | Week 52 | 28.5 percentage of participants |
| ARQ-151-315: VC/RC 0.05% or 0.15% Group | Percentage of Participants With vIGA-AD Success | Week 36 | 22.4 percentage of participants |
| ARQ-151-315: VC/RC 0.05% or 0.15% Group | Percentage of Participants With vIGA-AD Success | Week 4 | 11.1 percentage of participants |
Secondary
Percent Change From Baseline in EASI Score
EASI is an instrument to measure the severity and extent of AD. The body is first divided into 4 areas: head (10% of skin), arms (20%), trunk (30%), and legs (40%). Then, the area affected is scored from 0 (0% involvement) to 6 (90%-100% involvement), and severity is scored from 0 ('none') to 3 ('severe'). EASI combines the area affected and severity ratings to get a final composite score ranging from 0 (no disease) to 72 (severe disease). Note that palms and soles were treated as appropriate but were not counted towards any measurements of EASI.
Time frame: Weeks 4, 12, 24, 36, and 52
Population: All randomized participants with data available are included.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ARQ-151-311/312: RC/RC 0.15% Group | Percent Change From Baseline in EASI Score | Week 36 | -73.81 Percent change in EASI score | Standard Deviation 31.3 |
| ARQ-151-311/312: RC/RC 0.15% Group | Percent Change From Baseline in EASI Score | Week 12 | -68.39 Percent change in EASI score | Standard Deviation 34.195 |
| ARQ-151-311/312: RC/RC 0.15% Group | Percent Change From Baseline in EASI Score | Week 52 | -74.57 Percent change in EASI score | Standard Deviation 35.16 |
| ARQ-151-311/312: RC/RC 0.15% Group | Percent Change From Baseline in EASI Score | Week 24 | -72.81 Percent change in EASI score | Standard Deviation 34.462 |
| ARQ-151-311/312: RC/RC 0.15% Group | Percent Change From Baseline in EASI Score | Week 4 | -63.23 Percent change in EASI score | Standard Deviation 39.702 |
| ARQ-151-311/312: VC/RC 0.15% Group | Percent Change From Baseline in EASI Score | Week 24 | -33.34 Percent change in EASI score | Standard Deviation 116.997 |
| ARQ-151-311/312: VC/RC 0.15% Group | Percent Change From Baseline in EASI Score | Week 36 | -39.20 Percent change in EASI score | Standard Deviation 104.744 |
| ARQ-151-311/312: VC/RC 0.15% Group | Percent Change From Baseline in EASI Score | Week 52 | -27.94 Percent change in EASI score | Standard Deviation 137.809 |
| ARQ-151-311/312: VC/RC 0.15% Group | Percent Change From Baseline in EASI Score | Week 12 | -17.95 Percent change in EASI score | Standard Deviation 152.845 |
| ARQ-151-311/312: VC/RC 0.15% Group | Percent Change From Baseline in EASI Score | Week 4 | -36.93 Percent change in EASI score | Standard Deviation 63.272 |
| ARQ-151-315: RC/RC 0.05% or 0.15% Group | Percent Change From Baseline in EASI Score | Week 24 | -71.04 Percent change in EASI score | Standard Deviation 36.124 |
| ARQ-151-315: RC/RC 0.05% or 0.15% Group | Percent Change From Baseline in EASI Score | Week 4 | -59.51 Percent change in EASI score | Standard Deviation 40.684 |
| ARQ-151-315: RC/RC 0.05% or 0.15% Group | Percent Change From Baseline in EASI Score | Week 12 | -62.02 Percent change in EASI score | Standard Deviation 49.438 |
| ARQ-151-315: RC/RC 0.05% or 0.15% Group | Percent Change From Baseline in EASI Score | Week 36 | -69.75 Percent change in EASI score | Standard Deviation 40.467 |
| ARQ-151-315: RC/RC 0.05% or 0.15% Group | Percent Change From Baseline in EASI Score | Week 52 | -77.78 Percent change in EASI score | Standard Deviation 35.095 |
| ARQ-151-315: VC/RC 0.05% or 0.15% Group | Percent Change From Baseline in EASI Score | Week 36 | -39.39 Percent change in EASI score | Standard Deviation 148.094 |
| ARQ-151-315: VC/RC 0.05% or 0.15% Group | Percent Change From Baseline in EASI Score | Week 12 | -16.11 Percent change in EASI score | Standard Deviation 241.787 |
| ARQ-151-315: VC/RC 0.05% or 0.15% Group | Percent Change From Baseline in EASI Score | Week 4 | -41.29 Percent change in EASI score | Standard Deviation 53.042 |
| ARQ-151-315: VC/RC 0.05% or 0.15% Group | Percent Change From Baseline in EASI Score | Week 24 | -32.65 Percent change in EASI score | Standard Deviation 16.532 |
| ARQ-151-315: VC/RC 0.05% or 0.15% Group | Percent Change From Baseline in EASI Score | Week 52 | -52.36 Percent change in EASI score | Standard Deviation 74.751 |
Secondary
Validated Investigator Global Assessment-Atopic Dermatitis (vIGA-AD) Score of 0 or 1 at Each Assessment
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 as score of 0 'clear' to 4 'severe' ), with lower scores indicating reduced symptom severity and vice versa. Multiple imputation was used to handle missing data up to Week 24 or 52 for 24- and 52-week cohorts.
Time frame: Weeks 4, 12, 24, 36, and 52
Population: All randomized participants are included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ARQ-151-311/312: RC/RC 0.15% Group | Validated Investigator Global Assessment-Atopic Dermatitis (vIGA-AD) Score of 0 or 1 at Each Assessment | Week 24 | 48.2 percentage of participants |
| ARQ-151-311/312: RC/RC 0.15% Group | Validated Investigator Global Assessment-Atopic Dermatitis (vIGA-AD) Score of 0 or 1 at Each Assessment | Week 52 | 47.9 percentage of participants |
| ARQ-151-311/312: RC/RC 0.15% Group | Validated Investigator Global Assessment-Atopic Dermatitis (vIGA-AD) Score of 0 or 1 at Each Assessment | Week 36 | 45.5 percentage of participants |
| ARQ-151-311/312: RC/RC 0.15% Group | Validated Investigator Global Assessment-Atopic Dermatitis (vIGA-AD) Score of 0 or 1 at Each Assessment | Week 4 | 40.1 percentage of participants |
| ARQ-151-311/312: RC/RC 0.15% Group | Validated Investigator Global Assessment-Atopic Dermatitis (vIGA-AD) Score of 0 or 1 at Each Assessment | Week 12 | 42.2 percentage of participants |
| ARQ-151-311/312: VC/RC 0.15% Group | Validated Investigator Global Assessment-Atopic Dermatitis (vIGA-AD) Score of 0 or 1 at Each Assessment | Week 24 | 46.3 percentage of participants |
| ARQ-151-311/312: VC/RC 0.15% Group | Validated Investigator Global Assessment-Atopic Dermatitis (vIGA-AD) Score of 0 or 1 at Each Assessment | Week 12 | 36.9 percentage of participants |
| ARQ-151-311/312: VC/RC 0.15% Group | Validated Investigator Global Assessment-Atopic Dermatitis (vIGA-AD) Score of 0 or 1 at Each Assessment | Week 52 | 45.0 percentage of participants |
| ARQ-151-311/312: VC/RC 0.15% Group | Validated Investigator Global Assessment-Atopic Dermatitis (vIGA-AD) Score of 0 or 1 at Each Assessment | Week 36 | 49.6 percentage of participants |
| ARQ-151-311/312: VC/RC 0.15% Group | Validated Investigator Global Assessment-Atopic Dermatitis (vIGA-AD) Score of 0 or 1 at Each Assessment | Week 4 | 35.7 percentage of participants |
| ARQ-151-315: RC/RC 0.05% or 0.15% Group | Validated Investigator Global Assessment-Atopic Dermatitis (vIGA-AD) Score of 0 or 1 at Each Assessment | Week 36 | 42.5 percentage of participants |
| ARQ-151-315: RC/RC 0.05% or 0.15% Group | Validated Investigator Global Assessment-Atopic Dermatitis (vIGA-AD) Score of 0 or 1 at Each Assessment | Week 52 | 50.4 percentage of participants |
| ARQ-151-315: RC/RC 0.05% or 0.15% Group | Validated Investigator Global Assessment-Atopic Dermatitis (vIGA-AD) Score of 0 or 1 at Each Assessment | Week 12 | 40.0 percentage of participants |
| ARQ-151-315: RC/RC 0.05% or 0.15% Group | Validated Investigator Global Assessment-Atopic Dermatitis (vIGA-AD) Score of 0 or 1 at Each Assessment | Week 24 | 46.4 percentage of participants |
| ARQ-151-315: RC/RC 0.05% or 0.15% Group | Validated Investigator Global Assessment-Atopic Dermatitis (vIGA-AD) Score of 0 or 1 at Each Assessment | Week 4 | 37.7 percentage of participants |
| ARQ-151-315: VC/RC 0.05% or 0.15% Group | Validated Investigator Global Assessment-Atopic Dermatitis (vIGA-AD) Score of 0 or 1 at Each Assessment | Week 52 | 56.9 percentage of participants |
| ARQ-151-315: VC/RC 0.05% or 0.15% Group | Validated Investigator Global Assessment-Atopic Dermatitis (vIGA-AD) Score of 0 or 1 at Each Assessment | Week 4 | 40.8 percentage of participants |
| ARQ-151-315: VC/RC 0.05% or 0.15% Group | Validated Investigator Global Assessment-Atopic Dermatitis (vIGA-AD) Score of 0 or 1 at Each Assessment | Week 12 | 53.0 percentage of participants |
| ARQ-151-315: VC/RC 0.05% or 0.15% Group | Validated Investigator Global Assessment-Atopic Dermatitis (vIGA-AD) Score of 0 or 1 at Each Assessment | Week 36 | 47.6 percentage of participants |
| ARQ-151-315: VC/RC 0.05% or 0.15% Group | Validated Investigator Global Assessment-Atopic Dermatitis (vIGA-AD) Score of 0 or 1 at Each Assessment | Week 24 | 54.3 percentage of participants |