Seborrheic Dermatitis
Conditions
Brief summary
This is an open-label, long-term safety study of roflumilast ARQ-154 foam 0.3% in subjects with seborrheic dermatitis involving up to 20% total Body Surface Area (BSA). Study was applied topically once daily for 52 weeks. Cohort 1 subjects are rollover subjects from study ARQ-154-203 (NCT04091646) and were rolled into treatment in the current study without interruption. Cohort 2 includes participants from ARQ-154-203 who began treatment in the current study after a gap from completing treatment in the prior study.
Interventions
DRUGARQ-154
ARQ-154 foam 0.3% applied once daily for 52 weeks
Sponsors
Arcutis Biotherapeutics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Subjects that consent to enter this open-label safety study may or may not have previously completed a companion study (ARQ-154 trial)
Eligibility
Sex/Gender
ALL
Age
9 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Participants legally competent to sign and give informed consent or (for adolescents) assent. 2. Males and females ages 9 years and older (inclusive) at the time of consent. 3. Females of childbearing potential (FOCBP) must have a negative serum pregnancy test at all study visits. 4. Post-menopausal women with spontaneous amenorrhea for at least 12 months or have undergone surgical sterilization. Cohort 1 only: 5. Subjects with seborrheic dermatitis who met eligibility criteria for a prior ARQ-154 study, successfully completed a prior ARQ-154 study through final visit and are able to immediately enroll into this long-term safety study on the final visit of the previous ARQ-154 study. Cohort 2 subjects that have not participated in a prior ARQ-154 study: 6. Clinical diagnosis of seborrheic dermatitis of at least 3 months duration as determined by the Investigator. Stable disease for the past 4 weeks. 7. Seborrheic dermatitis of the scalp and/or face and/or trunk and/or intertriginous areas up to ≤20% BSA involvement. 8. An Investigator Global Assessment (IGA) of disease severity of at least Moderate ('3') at Day 1. 9. Overall Assessment of Erythema and Overall Assessment of Scaling scores of Moderate ('2') at Day 1. Cohort 2 subjects that have participated in a prior ARQ-154 study: 10. Clinical diagnosis of seborrheic dermatitis of at least 3 months duration as determined by the Investigator. 11. Seborrheic dermatitis of the scalp and/or face and/or trunk and/or intertriginous areas up to ≤20% BSA involvement.
Exclusion criteria
1. Planned excessive exposure of treated area(s) to either natural or artificial sunlight, tanning bed or other LED. 2. Subjects with any condition on the treatment area which, in the opinion of the Investigator, could confound efficacy measurements. 3. Subjects unable to apply investigational product to the scalp due to physical limitation. 4. Known allergies to excipients in ARQ-154 foam. 5. Subjects who cannot discontinue the use of strong P-450 cytochrome inhibitors e.g., indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, ketoconazole, nefazodone, saquinavir, suboxone and telithromycin during the study period. 6. Known or suspected: * severe renal insufficiency or moderate to severe hepatic disorders * history of severe depression, suicidal ideation or C-SSRS indicative of suicidal ideation, whether lifetime or recent/recurrent. 7. Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding. 8. Subjects with any serious medical condition or laboratory abnormality that would prevent study participation or place the subject at significant risk, as determined by the Investigator. 9. Subjects with a history of chronic alcohol or drugs abuse within 6 months of initiation of investigational product. 10. Current or a history of cancer within 5 years with the exception of fully treated skin basal cell carcinoma, cutaneous squamous cell carcinoma or carcinoma in situ of the cervix. 11. Subjects who are unable to communicate, read or understand the local language, or who display another condition, which in the Investigator's opinion, makes them unsuitable for clinical study participation. 12. Subjects who are family members of the clinical study site, clinical study staff, or sponsor, or family members that live in the same household of enrolled subjects. Cohort 1 only: 13. Subjects who experienced an ARQ-154 treatment-related AE or a serious AE (SAE) that precluded further treatment with ARQ-154 foam in a prior ARQ-154 study. 14. Subjects that use any Excluded Medication and Treatments. Cohort 2 only: 15. Subjects who cannot discontinue treatment with therapies for the treatment of seborrheic dermatitis prior to the Day 1 visit and during the study according to Excluded Medications and Treatments. 16. Subjects with PHQ-8 \>10 or modified PHQ-A \>10 at Screening or Day 1. Cohort 2 subjects that have participated in a prior ARQ-154 study: 17. Subjects who experienced an ARQ-154 treatment-related AE or a serious AE (SAE) that precluded further treatment with ARQ-154 foam in a prior ARQ-154 study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With ≥1 Adverse Event (AE) | Up to 52 weeks | The number of participants with treatment-emergent AEs is reported. An AE is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to participation in the research. Data are presented according to cohort group assigned as treatment were identical in this study regardless of the treatment received in the prior study. |
| Number of Participants With ≥1 Serious Adverse Event (SAE) | Up to 52 weeks | The number of participants with treatment-emergent SAEs is reported. An SAE is any AE that results in death, is life-threatening (places the subject at immediate risk of death from the event as it occurred), requires inpatient hospitalization or prolongation of existing hospitalization, results in a persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, or is any other adverse event that, based upon appropriate medical judgment, may jeopardize the subject's health. Data are presented according to cohort group assigned as treatment were identical in this study regardless of the treatment received in the prior study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With an Investigator Global Assessment (IGA) Score of Completely Clear or Almost Clear | Weeks 4, 12, 24, 36, and 52 | The number of participants with an IGA score of 0 ('completely clear') or 1 ('almost clear') is presented. The IGA is a 5-point scale assessing the severity of seborrheic dermatitis, with scores ranging from 0 ('clear') to 4 ('severe'), and higher scores indicate greater symptom severity. |
| Achievement of IGA Success | Weeks 4, 12, 24, 36, and 52 | The number of participants achieving success in IGA assessment of disease severity is presented. Success was defined as achievement of an IGA score of 0 ('clear') or 1 ('almost clear') at Week 8, accompanied by a ≥2-grade improvement from baseline IGA score. The IGA is a 5-point scale assessing the severity of seborrheic dermatitis, with scores ranging from 0 ('clear') to 4 ('severe'), and higher scores indicate greater symptom severity. |
| Duration of IGA Success | Weeks 4, 12, 24, 36, and 52 | The duration of success in IGA assessment of disease severity is presented. Success was defined as achievement of an IGA score of 0 ('clear') or 1 ('almost clear') at Week 8, accompanied by a ≥2-grade improvement from baseline IGA score. The IGA is a 5-point scale assessing the severity of seborrheic dermatitis, with scores ranging from 0 ('clear') to 4 ('severe'), and higher scores indicate greater symptom severity. The time from first observation of IGA success to the first subsequent time a participant's disease response did not meet the criteria for IGA success is presented. The duration of IGA success for subjects who ended treatment in IGA success was censored at the last disease assessment date. |
| IGA Treatment-Free Interval | Weeks 4, 12, 24, 36, and 52 | The treatment-free interval is defined as time from when the participant achieves disease clearance (IGA score of 0 \[completely clear\]) and stops treatment of all lesions until the time of restarting treatment. |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled at 39 study centers in the US.
Pre-assignment details
Participants from study ARQ-154-203 were rolled over primarily into this study. A subset of participants from study ARQ-154-116 was also enrolled (Cohort 1 Group 2); these participants are not included in the efficacy analyses but baseline and safety information is presented.
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1 Group 1: ARQ-154-203 Roflumilast Foam 0.3% Without Treatment Gap Participants from ARQ-154-203 using roflumilast (ARQ-154) foam 0.3% in the prior study applied roflumilast foam 0.3% QD for 52 weeks in the present study with no gap in treatment. | 52 |
| Cohort 1 Group 1: ARQ 154-203 Vehicle Foam Rolled Over Without Treatment Gap Participants from ARQ-154-203 using vehicle foam in the prior study applied roflumilast foam 0.3% QD for 52 weeks in the present study with no gap in treatment. | 23 |
| Cohort 2 Group 3: ARQ-154-203 Roflumilast Foam 0.3% With Treatment Gap Participants from ARQ-154-203 using roflumilast foam in the prior study applied roflumilast foam 0.3% QD for 52 weeks in the present study with a gap in treatment. | 41 |
| Cohort 2 Group 3: ARQ-154-203 Vehicle Foam With Treatment Gap Participants from ARQ-154-203 using vehicle foam in the prior study applied roflumilast foam 0.3% QD for 52 weeks in the present study with a gap in treatment. | 17 |
| Cohort 2 Group 4: De Novo Participants Treatment naive participants who had not previously participated in a clinical study of roflumilast foam 0.3% applied roflumilast foam 0.3% QD for 52 weeks in the present study. | 267 |
| Cohort 1 Group 2: ARQ-154-116 Rollover Participants from study ARQ-154-116 applied roflumilast foam 0.3% in the present study. | 8 |
| Total | 408 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 1 | 0 | 4 | 0 |
| Overall Study | Lost to Follow-up | 4 | 3 | 1 | 1 | 29 | 0 |
| Overall Study | Other reason | 0 | 0 | 1 | 0 | 2 | 0 |
| Overall Study | Physician Decision | 0 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Protocol Violation | 1 | 0 | 0 | 0 | 2 | 0 |
| Overall Study | Withdrawal by Subject | 4 | 0 | 1 | 0 | 18 | 1 |
Baseline characteristics
| Characteristic | Cohort 1 Group 1: ARQ-154-203 Roflumilast Foam 0.3% Without Treatment Gap | Cohort 1 Group 1: ARQ 154-203 Vehicle Foam Rolled Over Without Treatment Gap | Cohort 2 Group 3: ARQ-154-203 Roflumilast Foam 0.3% With Treatment Gap | Cohort 2 Group 3: ARQ-154-203 Vehicle Foam With Treatment Gap | Cohort 2 Group 4: De Novo Participants | Cohort 1 Group 2: ARQ-154-116 Rollover | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 44.5 years STANDARD_DEVIATION 15.99 | 41.0 years STANDARD_DEVIATION 15.53 | 46.7 years STANDARD_DEVIATION 17.2 | 48.8 years STANDARD_DEVIATION 14.99 | 42.4 years STANDARD_DEVIATION 16.45 | 13.5 years STANDARD_DEVIATION 2.1 | 42.8 years STANDARD_DEVIATION 16.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 11 Participants | 10 Participants | 8 Participants | 0 Participants | 86 Participants | 6 Participants | 121 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 41 Participants | 13 Participants | 33 Participants | 17 Participants | 179 Participants | 2 Participants | 285 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 2 Participants |
| Investigator Global Assessment (IGA) Baseline Score 0 - Completely clear | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Investigator Global Assessment (IGA) Baseline Score 1 = Almost clear | 0 Participants | 7 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 9 Participants |
| Investigator Global Assessment (IGA) Baseline Score 2 = Mild | 0 Participants | 2 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 4 Participants |
| Investigator Global Assessment (IGA) Baseline Score 3 = Moderate | 44 Participants | 11 Participants | 38 Participants | 13 Participants | 235 Participants | 5 Participants | 346 Participants |
| Investigator Global Assessment (IGA) Baseline Score 4 = Severe | 8 Participants | 1 Participants | 3 Participants | 0 Participants | 32 Participants | 3 Participants | 47 Participants |
| Race/Ethnicity, Customized Asian | 3 Participants | 0 Participants | 1 Participants | 0 Participants | 13 Participants | 1 Participants | 18 Participants |
| Race/Ethnicity, Customized Black or African-American | 5 Participants | 2 Participants | 4 Participants | 2 Participants | 38 Participants | 0 Participants | 51 Participants |
| Race/Ethnicity, Customized Missing | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized More than one race | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 4 Participants |
| Race/Ethnicity, Customized Native Hawaii or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 4 Participants | 0 Participants | 6 Participants |
| Race/Ethnicity, Customized White | 42 Participants | 19 Participants | 36 Participants | 15 Participants | 207 Participants | 6 Participants | 325 Participants |
| Sex: Female, Male Female | 27 Participants | 9 Participants | 21 Participants | 8 Participants | 138 Participants | 4 Participants | 207 Participants |
| Sex: Female, Male Male | 25 Participants | 14 Participants | 20 Participants | 9 Participants | 129 Participants | 4 Participants | 201 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 / 75 | 0 / 58 | 1 / 267 | 0 / 8 |
| other Total, other adverse events | 3 / 75 | 4 / 58 | 11 / 267 | 6 / 8 |
| serious Total, serious adverse events | 2 / 75 | 0 / 58 | 5 / 267 | 0 / 8 |
Outcome results
Primary
Number of Participants With ≥1 Adverse Event (AE)
The number of participants with treatment-emergent AEs is reported. An AE is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to participation in the research. Data are presented according to cohort group assigned as treatment were identical in this study regardless of the treatment received in the prior study.
Time frame: Up to 52 weeks
Population: All participants are included.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1 Group 1: ARQ-154-203 Roflumilast Foam 0.3% Without Treatment Gap | Number of Participants With ≥1 Adverse Event (AE) | 17 Participants |
| Cohort 2 Groups 3 and 4: ARQ-154-203 Roflumilast Foam 0.3% With Treatment Gap | Number of Participants With ≥1 Adverse Event (AE) | 23 Participants |
| Cohort 2 Group 4: De Novo Participants | Number of Participants With ≥1 Adverse Event (AE) | 90 Participants |
| Cohort 1 Group 2: ARQ-154-116 Rollover | Number of Participants With ≥1 Adverse Event (AE) | 3 Participants |
Primary
Number of Participants With ≥1 Serious Adverse Event (SAE)
The number of participants with treatment-emergent SAEs is reported. An SAE is any AE that results in death, is life-threatening (places the subject at immediate risk of death from the event as it occurred), requires inpatient hospitalization or prolongation of existing hospitalization, results in a persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, or is any other adverse event that, based upon appropriate medical judgment, may jeopardize the subject's health. Data are presented according to cohort group assigned as treatment were identical in this study regardless of the treatment received in the prior study.
Time frame: Up to 52 weeks
Population: All participants are included.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1 Group 1: ARQ-154-203 Roflumilast Foam 0.3% Without Treatment Gap | Number of Participants With ≥1 Serious Adverse Event (SAE) | 2 Participants |
| Cohort 2 Groups 3 and 4: ARQ-154-203 Roflumilast Foam 0.3% With Treatment Gap | Number of Participants With ≥1 Serious Adverse Event (SAE) | 0 Participants |
| Cohort 2 Group 4: De Novo Participants | Number of Participants With ≥1 Serious Adverse Event (SAE) | 5 Participants |
| Cohort 1 Group 2: ARQ-154-116 Rollover | Number of Participants With ≥1 Serious Adverse Event (SAE) | 0 Participants |
Secondary
Achievement of IGA Success
The number of participants achieving success in IGA assessment of disease severity is presented. Success was defined as achievement of an IGA score of 0 ('clear') or 1 ('almost clear') at Week 8, accompanied by a ≥2-grade improvement from baseline IGA score. The IGA is a 5-point scale assessing the severity of seborrheic dermatitis, with scores ranging from 0 ('clear') to 4 ('severe'), and higher scores indicate greater symptom severity.
Time frame: Weeks 4, 12, 24, 36, and 52
Population: All treated participants with data available and who had baseline IGA score ≥2 are included.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1 Group 1: ARQ-154-203 Roflumilast Foam 0.3% Without Treatment Gap | Achievement of IGA Success | Week 36 | 0 Participants |
| Cohort 1 Group 1: ARQ-154-203 Roflumilast Foam 0.3% Without Treatment Gap | Achievement of IGA Success | Week 52 | 0 Participants |
| Cohort 1 Group 1: ARQ-154-203 Roflumilast Foam 0.3% Without Treatment Gap | Achievement of IGA Success | Week 4 | 36 Participants |
| Cohort 1 Group 1: ARQ-154-203 Roflumilast Foam 0.3% Without Treatment Gap | Achievement of IGA Success | Week 24 | 31 Participants |
| Cohort 1 Group 1: ARQ-154-203 Roflumilast Foam 0.3% Without Treatment Gap | Achievement of IGA Success | Week 12 | 35 Participants |
| Cohort 2 Groups 3 and 4: ARQ-154-203 Roflumilast Foam 0.3% With Treatment Gap | Achievement of IGA Success | Week 4 | 6 Participants |
| Cohort 2 Groups 3 and 4: ARQ-154-203 Roflumilast Foam 0.3% With Treatment Gap | Achievement of IGA Success | Week 36 | 0 Participants |
| Cohort 2 Groups 3 and 4: ARQ-154-203 Roflumilast Foam 0.3% With Treatment Gap | Achievement of IGA Success | Week 24 | 10 Participants |
| Cohort 2 Groups 3 and 4: ARQ-154-203 Roflumilast Foam 0.3% With Treatment Gap | Achievement of IGA Success | Week 52 | 0 Participants |
| Cohort 2 Groups 3 and 4: ARQ-154-203 Roflumilast Foam 0.3% With Treatment Gap | Achievement of IGA Success | Week 12 | 7 Participants |
| Cohort 2 Group 4: De Novo Participants | Achievement of IGA Success | Week 12 | 25 Participants |
| Cohort 2 Group 4: De Novo Participants | Achievement of IGA Success | Week 52 | 1 Participants |
| Cohort 2 Group 4: De Novo Participants | Achievement of IGA Success | Week 36 | 0 Participants |
| Cohort 2 Group 4: De Novo Participants | Achievement of IGA Success | Week 4 | 20 Participants |
| Cohort 2 Group 4: De Novo Participants | Achievement of IGA Success | Week 24 | 24 Participants |
| Cohort 1 Group 2: ARQ-154-116 Rollover | Achievement of IGA Success | Week 24 | 11 Participants |
| Cohort 1 Group 2: ARQ-154-116 Rollover | Achievement of IGA Success | Week 4 | 8 Participants |
| Cohort 1 Group 2: ARQ-154-116 Rollover | Achievement of IGA Success | Week 12 | 11 Participants |
| Cohort 1 Group 2: ARQ-154-116 Rollover | Achievement of IGA Success | Week 36 | 0 Participants |
| Cohort 1 Group 2: ARQ-154-116 Rollover | Achievement of IGA Success | Week 52 | 1 Participants |
| Cohort 2 Group 4: De Novo Participants | Achievement of IGA Success | Week 36 | 37 Participants |
| Cohort 2 Group 4: De Novo Participants | Achievement of IGA Success | Week 4 | 137 Participants |
| Cohort 2 Group 4: De Novo Participants | Achievement of IGA Success | Week 52 | 35 Participants |
| Cohort 2 Group 4: De Novo Participants | Achievement of IGA Success | Week 12 | 172 Participants |
| Cohort 2 Group 4: De Novo Participants | Achievement of IGA Success | Week 24 | 177 Participants |
| Cohort 1 Group 2: ARQ-154-116 Rollover | Achievement of IGA Success | Week 4 | 5 Participants |
| Cohort 1 Group 2: ARQ-154-116 Rollover | Achievement of IGA Success | Week 36 | 0 Participants |
| Cohort 1 Group 2: ARQ-154-116 Rollover | Achievement of IGA Success | Week 12 | 5 Participants |
| Cohort 1 Group 2: ARQ-154-116 Rollover | Achievement of IGA Success | Week 52 | 0 Participants |
| Cohort 1 Group 2: ARQ-154-116 Rollover | Achievement of IGA Success | Week 24 | 3 Participants |
Secondary
Duration of IGA Success
The duration of success in IGA assessment of disease severity is presented. Success was defined as achievement of an IGA score of 0 ('clear') or 1 ('almost clear') at Week 8, accompanied by a ≥2-grade improvement from baseline IGA score. The IGA is a 5-point scale assessing the severity of seborrheic dermatitis, with scores ranging from 0 ('clear') to 4 ('severe'), and higher scores indicate greater symptom severity. The time from first observation of IGA success to the first subsequent time a participant's disease response did not meet the criteria for IGA success is presented. The duration of IGA success for subjects who ended treatment in IGA success was censored at the last disease assessment date.
Time frame: Weeks 4, 12, 24, 36, and 52
Population: All treated participants who achieved IGA success and had data available are included.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1 Group 1: ARQ-154-203 Roflumilast Foam 0.3% Without Treatment Gap | Duration of IGA Success | 18.786 weeks |
| Cohort 2 Groups 3 and 4: ARQ-154-203 Roflumilast Foam 0.3% With Treatment Gap | Duration of IGA Success | 12.143 weeks |
| Cohort 2 Group 4: De Novo Participants | Duration of IGA Success | 7.714 weeks |
| Cohort 1 Group 2: ARQ-154-116 Rollover | Duration of IGA Success | 13.143 weeks |
| Cohort 2 Group 4: De Novo Participants | Duration of IGA Success | 19.00 weeks |
| Cohort 1 Group 2: ARQ-154-116 Rollover | Duration of IGA Success | 10.00 weeks |
Secondary
IGA Treatment-Free Interval
The treatment-free interval is defined as time from when the participant achieves disease clearance (IGA score of 0 \[completely clear\]) and stops treatment of all lesions until the time of restarting treatment.
Time frame: Weeks 4, 12, 24, 36, and 52
Population: All treated participants who achieved an IGA score of 0 are included.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1 Group 1: ARQ-154-203 Roflumilast Foam 0.3% Without Treatment Gap | IGA Treatment-Free Interval | 19.143 weeks |
| Cohort 2 Groups 3 and 4: ARQ-154-203 Roflumilast Foam 0.3% With Treatment Gap | IGA Treatment-Free Interval | 11.766 weeks |
| Cohort 2 Group 4: De Novo Participants | IGA Treatment-Free Interval | 11.929 weeks |
| Cohort 1 Group 2: ARQ-154-116 Rollover | IGA Treatment-Free Interval | 14.143 weeks |
| Cohort 2 Group 4: De Novo Participants | IGA Treatment-Free Interval | 12.143 weeks |
| Cohort 1 Group 2: ARQ-154-116 Rollover | IGA Treatment-Free Interval | 20.143 weeks |
Secondary
Number of Participants With an Investigator Global Assessment (IGA) Score of Completely Clear or Almost Clear
The number of participants with an IGA score of 0 ('completely clear') or 1 ('almost clear') is presented. The IGA is a 5-point scale assessing the severity of seborrheic dermatitis, with scores ranging from 0 ('clear') to 4 ('severe'), and higher scores indicate greater symptom severity.
Time frame: Weeks 4, 12, 24, 36, and 52
Population: All treated participants with data available and who had baseline IGA score \>1 are included.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1 Group 1: ARQ-154-203 Roflumilast Foam 0.3% Without Treatment Gap | Number of Participants With an Investigator Global Assessment (IGA) Score of Completely Clear or Almost Clear | Week 4 | 36 Participants |
| Cohort 1 Group 1: ARQ-154-203 Roflumilast Foam 0.3% Without Treatment Gap | Number of Participants With an Investigator Global Assessment (IGA) Score of Completely Clear or Almost Clear | Week 12 | 35 Participants |
| Cohort 1 Group 1: ARQ-154-203 Roflumilast Foam 0.3% Without Treatment Gap | Number of Participants With an Investigator Global Assessment (IGA) Score of Completely Clear or Almost Clear | Week 24 | 31 Participants |
| Cohort 2 Groups 3 and 4: ARQ-154-203 Roflumilast Foam 0.3% With Treatment Gap | Number of Participants With an Investigator Global Assessment (IGA) Score of Completely Clear or Almost Clear | Week 12 | 7 Participants |
| Cohort 2 Groups 3 and 4: ARQ-154-203 Roflumilast Foam 0.3% With Treatment Gap | Number of Participants With an Investigator Global Assessment (IGA) Score of Completely Clear or Almost Clear | Week 4 | 7 Participants |
| Cohort 2 Groups 3 and 4: ARQ-154-203 Roflumilast Foam 0.3% With Treatment Gap | Number of Participants With an Investigator Global Assessment (IGA) Score of Completely Clear or Almost Clear | Week 24 | 10 Participants |
| Cohort 2 Group 4: De Novo Participants | Number of Participants With an Investigator Global Assessment (IGA) Score of Completely Clear or Almost Clear | Week 4 | 20 Participants |
| Cohort 2 Group 4: De Novo Participants | Number of Participants With an Investigator Global Assessment (IGA) Score of Completely Clear or Almost Clear | Week 12 | 25 Participants |
| Cohort 2 Group 4: De Novo Participants | Number of Participants With an Investigator Global Assessment (IGA) Score of Completely Clear or Almost Clear | Week 24 | 24 Participants |
| Cohort 2 Group 4: De Novo Participants | Number of Participants With an Investigator Global Assessment (IGA) Score of Completely Clear or Almost Clear | Week 36 | 0 Participants |
| Cohort 2 Group 4: De Novo Participants | Number of Participants With an Investigator Global Assessment (IGA) Score of Completely Clear or Almost Clear | Week 52 | 1 Participants |
| Cohort 1 Group 2: ARQ-154-116 Rollover | Number of Participants With an Investigator Global Assessment (IGA) Score of Completely Clear or Almost Clear | Week 12 | 12 Participants |
| Cohort 1 Group 2: ARQ-154-116 Rollover | Number of Participants With an Investigator Global Assessment (IGA) Score of Completely Clear or Almost Clear | Week 4 | 10 Participants |
| Cohort 1 Group 2: ARQ-154-116 Rollover | Number of Participants With an Investigator Global Assessment (IGA) Score of Completely Clear or Almost Clear | Week 24 | 11 Participants |
| Cohort 1 Group 2: ARQ-154-116 Rollover | Number of Participants With an Investigator Global Assessment (IGA) Score of Completely Clear or Almost Clear | Week 36 | 0 Participants |
| Cohort 1 Group 2: ARQ-154-116 Rollover | Number of Participants With an Investigator Global Assessment (IGA) Score of Completely Clear or Almost Clear | Week 52 | 1 Participants |
| Cohort 2 Group 4: De Novo Participants | Number of Participants With an Investigator Global Assessment (IGA) Score of Completely Clear or Almost Clear | Week 24 | 177 Participants |
| Cohort 2 Group 4: De Novo Participants | Number of Participants With an Investigator Global Assessment (IGA) Score of Completely Clear or Almost Clear | Week 12 | 172 Participants |
| Cohort 2 Group 4: De Novo Participants | Number of Participants With an Investigator Global Assessment (IGA) Score of Completely Clear or Almost Clear | Week 36 | 37 Participants |
| Cohort 2 Group 4: De Novo Participants | Number of Participants With an Investigator Global Assessment (IGA) Score of Completely Clear or Almost Clear | Week 52 | 35 Participants |
| Cohort 2 Group 4: De Novo Participants | Number of Participants With an Investigator Global Assessment (IGA) Score of Completely Clear or Almost Clear | Week 4 | 137 Participants |
| Cohort 1 Group 2: ARQ-154-116 Rollover | Number of Participants With an Investigator Global Assessment (IGA) Score of Completely Clear or Almost Clear | Week 24 | 3 Participants |
| Cohort 1 Group 2: ARQ-154-116 Rollover | Number of Participants With an Investigator Global Assessment (IGA) Score of Completely Clear or Almost Clear | Week 4 | 5 Participants |
| Cohort 1 Group 2: ARQ-154-116 Rollover | Number of Participants With an Investigator Global Assessment (IGA) Score of Completely Clear or Almost Clear | Week 12 | 5 Participants |