Trial Outcomes & Findings for Long-Term Safety of ARQ-154 Foam in Subjects With Seborrheic Dermatitis (NCT NCT04445987)

Last Updated: 2024-06-11

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

408 participants

Primary outcome timeframe

Up to 52 weeks

Results posted on

2024-06-11

Participant Flow

Participants were enrolled at 39 study centers in the US.

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.

Participant milestones

Participant milestones
Measure	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.	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.	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.	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.	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.	Cohort 1 Group 2: ARQ-154-116 Rollover Participants from study ARQ-154-116 applied roflumilast foam 0.3% in the present study.
Overall Study STARTED	52	23	41	17	267	8
Overall Study COMPLETED	43	20	37	16	211	7
Overall Study NOT COMPLETED	9	3	4	1	56	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.	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.	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.	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.	Cohort 1 Group 2: ARQ-154-116 Rollover Participants from study ARQ-154-116 applied roflumilast foam 0.3% in the present study.
Overall Study Adverse Event	0	0	1	0	4	0
Overall Study Lost to Follow-up	4	3	1	1	29	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
Overall Study Other reason	0	0	1	0	2	0

Baseline Characteristics

Long-Term Safety of ARQ-154 Foam in Subjects With Seborrheic Dermatitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1 Group 1: ARQ-154-203 Roflumilast Foam 0.3% Without Treatment Gap n=52 Participants 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.	Cohort 1 Group 1: ARQ 154-203 Vehicle Foam Rolled Over Without Treatment Gap n=23 Participants 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.	Cohort 2 Group 3: ARQ-154-203 Roflumilast Foam 0.3% With Treatment Gap n=41 Participants 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.	Cohort 2 Group 3: ARQ-154-203 Vehicle Foam With Treatment Gap n=17 Participants 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.	Cohort 2 Group 4: De Novo Participants n=267 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.	Cohort 1 Group 2: ARQ-154-116 Rollover n=8 Participants Participants from study ARQ-154-116 applied roflumilast foam 0.3% in the present study.	Total n=408 Participants Total of all reporting groups
Age, Continuous	44.5 years STANDARD_DEVIATION 15.99 • n=5 Participants	41.0 years STANDARD_DEVIATION 15.53 • n=7 Participants	46.7 years STANDARD_DEVIATION 17.20 • n=5 Participants	48.8 years STANDARD_DEVIATION 14.99 • n=4 Participants	42.4 years STANDARD_DEVIATION 16.45 • n=21 Participants	13.5 years STANDARD_DEVIATION 2.1 • n=8 Participants	42.8 years STANDARD_DEVIATION 16.8 • n=8 Participants
Sex: Female, Male Female	27 Participants n=5 Participants	9 Participants n=7 Participants	21 Participants n=5 Participants	8 Participants n=4 Participants	138 Participants n=21 Participants	4 Participants n=8 Participants	207 Participants n=8 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	14 Participants n=7 Participants	20 Participants n=5 Participants	9 Participants n=4 Participants	129 Participants n=21 Participants	4 Participants n=8 Participants	201 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	11 Participants n=5 Participants	10 Participants n=7 Participants	8 Participants n=5 Participants	0 Participants n=4 Participants	86 Participants n=21 Participants	6 Participants n=8 Participants	121 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	41 Participants n=5 Participants	13 Participants n=7 Participants	33 Participants n=5 Participants	17 Participants n=4 Participants	179 Participants n=21 Participants	2 Participants n=8 Participants	285 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants	0 Participants n=8 Participants	2 Participants n=8 Participants
Race/Ethnicity, Customized Asian	3 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	13 Participants n=21 Participants	1 Participants n=8 Participants	18 Participants n=8 Participants
Race/Ethnicity, Customized Black or African-American	5 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	2 Participants n=4 Participants	38 Participants n=21 Participants	0 Participants n=8 Participants	51 Participants n=8 Participants
Race/Ethnicity, Customized Native Hawaii or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants
Race/Ethnicity, Customized White	42 Participants n=5 Participants	19 Participants n=7 Participants	36 Participants n=5 Participants	15 Participants n=4 Participants	207 Participants n=21 Participants	6 Participants n=8 Participants	325 Participants n=8 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	4 Participants n=21 Participants	0 Participants n=8 Participants	6 Participants n=8 Participants
Race/Ethnicity, Customized More than one race	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=8 Participants	4 Participants n=8 Participants
Race/Ethnicity, Customized Missing	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants	0 Participants n=8 Participants	3 Participants n=8 Participants
Investigator Global Assessment (IGA) Baseline Score 0 - Completely clear	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	2 Participants n=8 Participants
Investigator Global Assessment (IGA) Baseline Score 1 = Almost clear	0 Participants n=5 Participants	7 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	9 Participants n=8 Participants
Investigator Global Assessment (IGA) Baseline Score 2 = Mild	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	4 Participants n=8 Participants
Investigator Global Assessment (IGA) Baseline Score 3 = Moderate	44 Participants n=5 Participants	11 Participants n=7 Participants	38 Participants n=5 Participants	13 Participants n=4 Participants	235 Participants n=21 Participants	5 Participants n=8 Participants	346 Participants n=8 Participants
Investigator Global Assessment (IGA) Baseline Score 4 = Severe	8 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	0 Participants n=4 Participants	32 Participants n=21 Participants	3 Participants n=8 Participants	47 Participants n=8 Participants

PRIMARY outcome

Timeframe: Up to 52 weeks

Population: All participants are included.

Outcome measures

Outcome measures
Measure	Cohort 1 Group 1: ARQ-154-203 Roflumilast Foam 0.3% Without Treatment Gap n=75 Participants Participants from ARQ-154-203 using either roflumilast foam 0.3% or vehicle foam in the prior study applied roflumilast foam 0.3% QD for 52 weeks in the present study with no gap in treatment.	Cohort 2 Groups 3 and 4: ARQ-154-203 Roflumilast Foam 0.3% With Treatment Gap n=58 Participants Participants from ARQ-154-203 using roflumilast foam 0.3% or vehicle foam in the prior study applied roflumilast foam 0.3% QD for 52 weeks in the present study with a gap in treatment.	Cohort 2 Group 4: De Novo Participants n=267 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.	Cohort 1 Group 2: ARQ-154-116 Rollover n=8 Participants Participants from study ARQ-154-116 applied roflumilast foam 0.3% in the present study.	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.	Cohort 1 Group 2: ARQ-154-116 Rollover Participants from study ARQ-154-116 applied roflumilast foam 0.3% in the present study.
Number of Participants With ≥1 Adverse Event (AE)	17 Participants	23 Participants	90 Participants	3 Participants	—	—

PRIMARY outcome

Timeframe: Up to 52 weeks

Population: All participants are included.

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.

Outcome measures

Outcome measures
Measure	Cohort 1 Group 1: ARQ-154-203 Roflumilast Foam 0.3% Without Treatment Gap n=75 Participants Participants from ARQ-154-203 using either roflumilast foam 0.3% or vehicle foam in the prior study applied roflumilast foam 0.3% QD for 52 weeks in the present study with no gap in treatment.	Cohort 2 Groups 3 and 4: ARQ-154-203 Roflumilast Foam 0.3% With Treatment Gap n=58 Participants Participants from ARQ-154-203 using roflumilast foam 0.3% or vehicle foam in the prior study applied roflumilast foam 0.3% QD for 52 weeks in the present study with a gap in treatment.	Cohort 2 Group 4: De Novo Participants n=267 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.	Cohort 1 Group 2: ARQ-154-116 Rollover n=8 Participants Participants from study ARQ-154-116 applied roflumilast foam 0.3% in the present study.	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.	Cohort 1 Group 2: ARQ-154-116 Rollover Participants from study ARQ-154-116 applied roflumilast foam 0.3% in the present study.
Number of Participants With ≥1 Serious Adverse Event (SAE)	2 Participants	0 Participants	5 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: Weeks 4, 12, 24, 36, and 52

Population: All treated participants with data available and who had baseline IGA score \>1 are included.

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.

Outcome measures

Outcome measures
Measure	Cohort 1 Group 1: ARQ-154-203 Roflumilast Foam 0.3% Without Treatment Gap n=52 Participants Participants from ARQ-154-203 using either roflumilast foam 0.3% or vehicle foam in the prior study applied roflumilast foam 0.3% QD for 52 weeks in the present study with no gap in treatment.	Cohort 2 Groups 3 and 4: ARQ-154-203 Roflumilast Foam 0.3% With Treatment Gap n=23 Participants Participants from ARQ-154-203 using roflumilast foam 0.3% or vehicle foam in the prior study applied roflumilast foam 0.3% QD for 52 weeks in the present study with a gap in treatment.	Cohort 2 Group 4: De Novo Participants n=41 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.	Cohort 1 Group 2: ARQ-154-116 Rollover n=17 Participants Participants from study ARQ-154-116 applied roflumilast foam 0.3% in the present study.	Cohort 2 Group 4: De Novo Participants n=267 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.	Cohort 1 Group 2: ARQ-154-116 Rollover n=7 Participants Participants from study ARQ-154-116 applied roflumilast foam 0.3% in the present study.
Number of Participants With an Investigator Global Assessment (IGA) Score of Completely Clear or Almost Clear Week 4	36 Participants	7 Participants	20 Participants	10 Participants	137 Participants	5 Participants
Number of Participants With an Investigator Global Assessment (IGA) Score of Completely Clear or Almost Clear Week 12	35 Participants	7 Participants	25 Participants	12 Participants	172 Participants	5 Participants
Number of Participants With an Investigator Global Assessment (IGA) Score of Completely Clear or Almost Clear Week 24	31 Participants	10 Participants	24 Participants	11 Participants	177 Participants	3 Participants
Number of Participants With an Investigator Global Assessment (IGA) Score of Completely Clear or Almost Clear Week 36	—	—	0 Participants	0 Participants	37 Participants	—
Number of Participants With an Investigator Global Assessment (IGA) Score of Completely Clear or Almost Clear Week 52	—	—	1 Participants	1 Participants	35 Participants	—

SECONDARY outcome

Timeframe: Weeks 4, 12, 24, 36, and 52

Population: All treated participants with data available and who had baseline IGA score ≥2 are included.

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.

Outcome measures

Outcome measures
Measure	Cohort 1 Group 1: ARQ-154-203 Roflumilast Foam 0.3% Without Treatment Gap n=50 Participants Participants from ARQ-154-203 using either roflumilast foam 0.3% or vehicle foam in the prior study applied roflumilast foam 0.3% QD for 52 weeks in the present study with no gap in treatment.	Cohort 2 Groups 3 and 4: ARQ-154-203 Roflumilast Foam 0.3% With Treatment Gap n=22 Participants Participants from ARQ-154-203 using roflumilast foam 0.3% or vehicle foam in the prior study applied roflumilast foam 0.3% QD for 52 weeks in the present study with a gap in treatment.	Cohort 2 Group 4: De Novo Participants n=39 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.	Cohort 1 Group 2: ARQ-154-116 Rollover n=17 Participants Participants from study ARQ-154-116 applied roflumilast foam 0.3% in the present study.	Cohort 2 Group 4: De Novo Participants n=260 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.	Cohort 1 Group 2: ARQ-154-116 Rollover n=7 Participants Participants from study ARQ-154-116 applied roflumilast foam 0.3% in the present study.
Achievement of IGA Success Week 4	36 Participants	6 Participants	20 Participants	8 Participants	137 Participants	5 Participants
Achievement of IGA Success Week 12	35 Participants	7 Participants	25 Participants	11 Participants	172 Participants	5 Participants
Achievement of IGA Success Week 24	31 Participants	10 Participants	24 Participants	11 Participants	177 Participants	3 Participants
Achievement of IGA Success Week 36	0 Participants	0 Participants	0 Participants	0 Participants	37 Participants	0 Participants
Achievement of IGA Success Week 52	0 Participants	0 Participants	1 Participants	1 Participants	35 Participants	0 Participants

SECONDARY outcome

Timeframe: Weeks 4, 12, 24, 36, and 52

Population: All treated participants who achieved IGA success and had data available are included.

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.

Outcome measures

Outcome measures
Measure	Cohort 1 Group 1: ARQ-154-203 Roflumilast Foam 0.3% Without Treatment Gap n=50 Participants Participants from ARQ-154-203 using either roflumilast foam 0.3% or vehicle foam in the prior study applied roflumilast foam 0.3% QD for 52 weeks in the present study with no gap in treatment.	Cohort 2 Groups 3 and 4: ARQ-154-203 Roflumilast Foam 0.3% With Treatment Gap n=11 Participants Participants from ARQ-154-203 using roflumilast foam 0.3% or vehicle foam in the prior study applied roflumilast foam 0.3% QD for 52 weeks in the present study with a gap in treatment.	Cohort 2 Group 4: De Novo Participants n=61 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.	Cohort 1 Group 2: ARQ-154-116 Rollover n=35 Participants Participants from study ARQ-154-116 applied roflumilast foam 0.3% in the present study.	Cohort 2 Group 4: De Novo Participants n=229 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.	Cohort 1 Group 2: ARQ-154-116 Rollover n=6 Participants Participants from study ARQ-154-116 applied roflumilast foam 0.3% in the present study.
Duration of IGA Success	18.786 weeks Interval 0.14 to 32.29	12.143 weeks Interval 0.14 to 22.29	7.714 weeks Interval 0.14 to 30.43	13.143 weeks Interval 0.14 to 31.86	19.00 weeks Interval 0.14 to 50.14	10.00 weeks Interval 3.57 to 23.71

SECONDARY outcome

Timeframe: Weeks 4, 12, 24, 36, and 52

Population: All treated participants who achieved an IGA score of 0 are included.

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.

Outcome measures

Outcome measures
Measure	Cohort 1 Group 1: ARQ-154-203 Roflumilast Foam 0.3% Without Treatment Gap n=15 Participants Participants from ARQ-154-203 using either roflumilast foam 0.3% or vehicle foam in the prior study applied roflumilast foam 0.3% QD for 52 weeks in the present study with no gap in treatment.	Cohort 2 Groups 3 and 4: ARQ-154-203 Roflumilast Foam 0.3% With Treatment Gap n=8 Participants Participants from ARQ-154-203 using roflumilast foam 0.3% or vehicle foam in the prior study applied roflumilast foam 0.3% QD for 52 weeks in the present study with a gap in treatment.	Cohort 2 Group 4: De Novo Participants n=18 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.	Cohort 1 Group 2: ARQ-154-116 Rollover n=7 Participants Participants from study ARQ-154-116 applied roflumilast foam 0.3% in the present study.	Cohort 2 Group 4: De Novo Participants n=90 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.	Cohort 1 Group 2: ARQ-154-116 Rollover n=3 Participants Participants from study ARQ-154-116 applied roflumilast foam 0.3% in the present study.
IGA Treatment-Free Interval	19.143 weeks Interval 0.57 to 24.0	11.766 weeks Interval 2.57 to 24.43	11.929 weeks Interval 1.14 to 22.14	14.143 weeks Interval 2.43 to 22.0	12.143 weeks Interval 0.29 to 49.14	20.143 weeks Interval 8.143 to 23.14

Adverse Events

Cohort 1 Group 1: ARQ-154-203 Roflumilast Foam 0.3% Without Treatment Gap

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Cohort 2 Group 3: ARQ-154-203 Roflumilast Foam 0.3% Without Treatment Gap

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Cohort 2 Group 4: De Novo Participants

Serious events: 5 serious events

Other events: 11 other events

Deaths: 1 deaths

Cohort 1 Group 2: ARQ-154-116 Rollover

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cohort 1 Group 1: ARQ-154-203 Roflumilast Foam 0.3% Without Treatment Gap n=75 participants at risk Participants from ARQ-154-203 using roflumilast foam 0.3% or vehicle foam in the prior study applied roflumilast foam 0.3% QD for 52 weeks in the present study with no gap in treatment.	Cohort 2 Group 3: ARQ-154-203 Roflumilast Foam 0.3% Without Treatment Gap n=58 participants at risk Participants from ARQ-154-203 using roflumilast 0.3% or vehicle foam in the prior study applied roflumilast foam 0.3% QD for 52 weeks in the present study with a gap in treatment.	Cohort 2 Group 4: De Novo Participants n=267 participants at risk 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.	Cohort 1 Group 2: ARQ-154-116 Rollover n=8 participants at risk Participants from study ARQ-154-116 applied roflumilast foam 0.3% in the present study.
Nervous system disorders Cerebrovascular accident	1.3% 1/75 • Up to 52 weeks All participants are included. Data are presented according to cohort group assigned as treatment were identical in this study regardless of the treatment received in the prior study.	0.00% 0/58 • Up to 52 weeks All participants are included. Data are presented according to cohort group assigned as treatment were identical in this study regardless of the treatment received in the prior study.	0.00% 0/267 • Up to 52 weeks All participants are included. Data are presented according to cohort group assigned as treatment were identical in this study regardless of the treatment received in the prior study.	0.00% 0/8 • Up to 52 weeks All participants are included. Data are presented according to cohort group assigned as treatment were identical in this study regardless of the treatment received in the prior study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain neoplasm malignant	0.00% 0/75 • Up to 52 weeks All participants are included. Data are presented according to cohort group assigned as treatment were identical in this study regardless of the treatment received in the prior study.	0.00% 0/58 • Up to 52 weeks All participants are included. Data are presented according to cohort group assigned as treatment were identical in this study regardless of the treatment received in the prior study.	0.37% 1/267 • Up to 52 weeks All participants are included. Data are presented according to cohort group assigned as treatment were identical in this study regardless of the treatment received in the prior study.	0.00% 0/8 • Up to 52 weeks All participants are included. Data are presented according to cohort group assigned as treatment were identical in this study regardless of the treatment received in the prior study.
Gastrointestinal disorders Abdominal pain	0.00% 0/75 • Up to 52 weeks All participants are included. Data are presented according to cohort group assigned as treatment were identical in this study regardless of the treatment received in the prior study.	0.00% 0/58 • Up to 52 weeks All participants are included. Data are presented according to cohort group assigned as treatment were identical in this study regardless of the treatment received in the prior study.	0.37% 1/267 • Up to 52 weeks All participants are included. Data are presented according to cohort group assigned as treatment were identical in this study regardless of the treatment received in the prior study.	0.00% 0/8 • Up to 52 weeks All participants are included. Data are presented according to cohort group assigned as treatment were identical in this study regardless of the treatment received in the prior study.
Gastrointestinal disorders Small intestinal obstruction	1.3% 1/75 • Up to 52 weeks All participants are included. Data are presented according to cohort group assigned as treatment were identical in this study regardless of the treatment received in the prior study.	0.00% 0/58 • Up to 52 weeks All participants are included. Data are presented according to cohort group assigned as treatment were identical in this study regardless of the treatment received in the prior study.	0.00% 0/267 • Up to 52 weeks All participants are included. Data are presented according to cohort group assigned as treatment were identical in this study regardless of the treatment received in the prior study.	0.00% 0/8 • Up to 52 weeks All participants are included. Data are presented according to cohort group assigned as treatment were identical in this study regardless of the treatment received in the prior study.
General disorders Performance status decreased	0.00% 0/75 • Up to 52 weeks All participants are included. Data are presented according to cohort group assigned as treatment were identical in this study regardless of the treatment received in the prior study.	0.00% 0/58 • Up to 52 weeks All participants are included. Data are presented according to cohort group assigned as treatment were identical in this study regardless of the treatment received in the prior study.	0.37% 1/267 • Up to 52 weeks All participants are included. Data are presented according to cohort group assigned as treatment were identical in this study regardless of the treatment received in the prior study.	0.00% 0/8 • Up to 52 weeks All participants are included. Data are presented according to cohort group assigned as treatment were identical in this study regardless of the treatment received in the prior study.
Infections and infestations COVID-19 pneumonia	0.00% 0/75 • Up to 52 weeks All participants are included. Data are presented according to cohort group assigned as treatment were identical in this study regardless of the treatment received in the prior study.	0.00% 0/58 • Up to 52 weeks All participants are included. Data are presented according to cohort group assigned as treatment were identical in this study regardless of the treatment received in the prior study.	0.37% 1/267 • Up to 52 weeks All participants are included. Data are presented according to cohort group assigned as treatment were identical in this study regardless of the treatment received in the prior study.	0.00% 0/8 • Up to 52 weeks All participants are included. Data are presented according to cohort group assigned as treatment were identical in this study regardless of the treatment received in the prior study.
Vascular disorders Hypertension	0.00% 0/75 • Up to 52 weeks All participants are included. Data are presented according to cohort group assigned as treatment were identical in this study regardless of the treatment received in the prior study.	0.00% 0/58 • Up to 52 weeks All participants are included. Data are presented according to cohort group assigned as treatment were identical in this study regardless of the treatment received in the prior study.	0.37% 1/267 • Up to 52 weeks All participants are included. Data are presented according to cohort group assigned as treatment were identical in this study regardless of the treatment received in the prior study.	0.00% 0/8 • Up to 52 weeks All participants are included. Data are presented according to cohort group assigned as treatment were identical in this study regardless of the treatment received in the prior study.

Other adverse events

Other adverse events
Measure	Cohort 1 Group 1: ARQ-154-203 Roflumilast Foam 0.3% Without Treatment Gap n=75 participants at risk Participants from ARQ-154-203 using roflumilast foam 0.3% or vehicle foam in the prior study applied roflumilast foam 0.3% QD for 52 weeks in the present study with no gap in treatment.	Cohort 2 Group 3: ARQ-154-203 Roflumilast Foam 0.3% Without Treatment Gap n=58 participants at risk Participants from ARQ-154-203 using roflumilast 0.3% or vehicle foam in the prior study applied roflumilast foam 0.3% QD for 52 weeks in the present study with a gap in treatment.	Cohort 2 Group 4: De Novo Participants n=267 participants at risk 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.	Cohort 1 Group 2: ARQ-154-116 Rollover n=8 participants at risk Participants from study ARQ-154-116 applied roflumilast foam 0.3% in the present study.
Infections and infestations COVID-19	4.0% 3/75 • Up to 52 weeks All participants are included. Data are presented according to cohort group assigned as treatment were identical in this study regardless of the treatment received in the prior study.	5.2% 3/58 • Up to 52 weeks All participants are included. Data are presented according to cohort group assigned as treatment were identical in this study regardless of the treatment received in the prior study.	3.4% 9/267 • Up to 52 weeks All participants are included. Data are presented according to cohort group assigned as treatment were identical in this study regardless of the treatment received in the prior study.	0.00% 0/8 • Up to 52 weeks All participants are included. Data are presented according to cohort group assigned as treatment were identical in this study regardless of the treatment received in the prior study.
Infections and infestations Urinary tract infection	0.00% 0/75 • Up to 52 weeks All participants are included. Data are presented according to cohort group assigned as treatment were identical in this study regardless of the treatment received in the prior study.	6.9% 4/58 • Up to 52 weeks All participants are included. Data are presented according to cohort group assigned as treatment were identical in this study regardless of the treatment received in the prior study.	1.1% 3/267 • Up to 52 weeks All participants are included. Data are presented according to cohort group assigned as treatment were identical in this study regardless of the treatment received in the prior study.	0.00% 0/8 • Up to 52 weeks All participants are included. Data are presented according to cohort group assigned as treatment were identical in this study regardless of the treatment received in the prior study.
Investigations Weight decreased	0.00% 0/75 • Up to 52 weeks All participants are included. Data are presented according to cohort group assigned as treatment were identical in this study regardless of the treatment received in the prior study.	0.00% 0/58 • Up to 52 weeks All participants are included. Data are presented according to cohort group assigned as treatment were identical in this study regardless of the treatment received in the prior study.	0.00% 0/267 • Up to 52 weeks All participants are included. Data are presented according to cohort group assigned as treatment were identical in this study regardless of the treatment received in the prior study.	12.5% 1/8 • Up to 52 weeks All participants are included. Data are presented according to cohort group assigned as treatment were identical in this study regardless of the treatment received in the prior study.
Psychiatric disorders Tic	0.00% 0/75 • Up to 52 weeks All participants are included. Data are presented according to cohort group assigned as treatment were identical in this study regardless of the treatment received in the prior study.	0.00% 0/58 • Up to 52 weeks All participants are included. Data are presented according to cohort group assigned as treatment were identical in this study regardless of the treatment received in the prior study.	0.00% 0/267 • Up to 52 weeks All participants are included. Data are presented according to cohort group assigned as treatment were identical in this study regardless of the treatment received in the prior study.	12.5% 1/8 • Up to 52 weeks All participants are included. Data are presented according to cohort group assigned as treatment were identical in this study regardless of the treatment received in the prior study.
Gastrointestinal disorders Dyspepsia	0.00% 0/75 • Up to 52 weeks All participants are included. Data are presented according to cohort group assigned as treatment were identical in this study regardless of the treatment received in the prior study.	0.00% 0/58 • Up to 52 weeks All participants are included. Data are presented according to cohort group assigned as treatment were identical in this study regardless of the treatment received in the prior study.	0.00% 0/267 • Up to 52 weeks All participants are included. Data are presented according to cohort group assigned as treatment were identical in this study regardless of the treatment received in the prior study.	12.5% 1/8 • Up to 52 weeks All participants are included. Data are presented according to cohort group assigned as treatment were identical in this study regardless of the treatment received in the prior study.
General disorders Application site alopecia	0.00% 0/75 • Up to 52 weeks All participants are included. Data are presented according to cohort group assigned as treatment were identical in this study regardless of the treatment received in the prior study.	0.00% 0/58 • Up to 52 weeks All participants are included. Data are presented according to cohort group assigned as treatment were identical in this study regardless of the treatment received in the prior study.	0.00% 0/267 • Up to 52 weeks All participants are included. Data are presented according to cohort group assigned as treatment were identical in this study regardless of the treatment received in the prior study.	12.5% 1/8 • Up to 52 weeks All participants are included. Data are presented according to cohort group assigned as treatment were identical in this study regardless of the treatment received in the prior study.
Investigations Transaminases increased	0.00% 0/75 • Up to 52 weeks All participants are included. Data are presented according to cohort group assigned as treatment were identical in this study regardless of the treatment received in the prior study.	0.00% 0/58 • Up to 52 weeks All participants are included. Data are presented according to cohort group assigned as treatment were identical in this study regardless of the treatment received in the prior study.	0.00% 0/267 • Up to 52 weeks All participants are included. Data are presented according to cohort group assigned as treatment were identical in this study regardless of the treatment received in the prior study.	12.5% 1/8 • Up to 52 weeks All participants are included. Data are presented according to cohort group assigned as treatment were identical in this study regardless of the treatment received in the prior study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pyogenic granuloma	0.00% 0/75 • Up to 52 weeks All participants are included. Data are presented according to cohort group assigned as treatment were identical in this study regardless of the treatment received in the prior study.	0.00% 0/58 • Up to 52 weeks All participants are included. Data are presented according to cohort group assigned as treatment were identical in this study regardless of the treatment received in the prior study.	0.00% 0/267 • Up to 52 weeks All participants are included. Data are presented according to cohort group assigned as treatment were identical in this study regardless of the treatment received in the prior study.	12.5% 1/8 • Up to 52 weeks All participants are included. Data are presented according to cohort group assigned as treatment were identical in this study regardless of the treatment received in the prior study.

Additional Information

Arcutis Medical Information

Arcutis Biotherapeutics

Phone: +1 844 692-6729

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Sponsor is supportive of publishing clinical trial findings. The process of coordinating publication efforts is detailed in the Clinical Trial Agreement.
Publication restrictions are in place

Restriction type: OTHER