CompletedNCT04445987Updated Jun 11, 2024Results posted

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

A Phase 2 interventional study of ARQ-154 in Seborrheic Dermatitis, sponsored by Arcutis Biotherapeutics, Inc.. Completed at 39 sites in United States. Open to participants aged 9 Years and older. Per ClinicalTrials.gov, last updated 2024-06-11.

Sponsored by Arcutis Biotherapeutics, Inc. · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 408
Allocation: Not applicable
Ages: 9 Years and older
Sex: All

Study 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.

Conditions studied

Seborrheic Dermatitis

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In context

Dermatitis

1,435 studies on the registry are indexed under Dermatitis; 131 are open to participants now.

This study's enrollment of 408 is above the median of 64 across 1,131 interventional studies indexed under Dermatitis.

Browse Dermatitis studies →

Lead sponsor

Arcutis Biotherapeutics, Inc. is the lead sponsor of 24 studies on the registry; 1 is open to participants now.

Of its 23 completed or terminated interventional studies of FDA-regulated products, 19 (83%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 9 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Participants legally competent to sign and give informed consent or (for adolescents) assent.
Males and females ages 9 years and older (inclusive) at the time of consent.
Females of childbearing potential (FOCBP) must have a negative serum pregnancy test at all study visits.
Post-menopausal women with spontaneous amenorrhea for at least 12 months or have undergone surgical sterilization.
Cohort 1 only:
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:
Clinical diagnosis of seborrheic dermatitis of at least 3 months duration as determined by the Investigator. Stable disease for the past 4 weeks.
Seborrheic dermatitis of the scalp and/or face and/or trunk and/or intertriginous areas up to ≤20% BSA involvement.
An Investigator Global Assessment (IGA) of disease severity of at least Moderate ('3') at Day 1.
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:
Clinical diagnosis of seborrheic dermatitis of at least 3 months duration as determined by the Investigator.
Seborrheic dermatitis of the scalp and/or face and/or trunk and/or intertriginous areas up to ≤20% BSA involvement.

Exclusion criteria

Exclusion Criteria:

Planned excessive exposure of treated area(s) to either natural or artificial sunlight, tanning bed or other LED.
Subjects with any condition on the treatment area which, in the opinion of the Investigator, could confound efficacy measurements.
Subjects unable to apply investigational product to the scalp due to physical limitation.
Known allergies to excipients in ARQ-154 foam.
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.
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.
Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
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.
Subjects with a history of chronic alcohol or drugs abuse within 6 months of initiation of investigational product.
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.
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.
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:
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.
Subjects that use any Excluded Medication and Treatments.
Cohort 2 only:
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.
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:
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.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 408 participants (actual)

Study arms

Experimental
Long-term safety of ARQ-154
Open-label, Long-term Safety of ARQ-154
Drug: ARQ-154

Interventions

DrugARQ-154
ARQ-154 foam 0.3% applied once daily for 52 weeks

What researchers measure

Primary outcomes

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
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

Secondary outcomes

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
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
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
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

Results

Posted Jun 11, 2024

Participant flow

Participants were enrolled at 39 study centers in the US.

Participant flow — Overall Study
Milestone	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
Started	52	23	41	17	267	8
Completed	43	20	37	16	211	7
Not completed	9	3	4	1	56	1
Withdrew: Adverse event	0	0	1	0	4	0
Withdrew: Lost to follow-up	4	3	1	1	29	0
Withdrew: Physician decision	0	0	0	0	1	0
Withdrew: Protocol violation	1	0	0	0	2	0
Withdrew: Withdrawal by subject	4	0	1	0	18	1
Withdrew: Other reason	0	0	1	0	2	0

Outcome measures

PrimaryNumber 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
Reported as:: Count of participants · Participants

Number of Participants With ≥1 Adverse Event (AE)
Participants	Cohort 1 Group 1: ARQ-154-203 Roflumilast Foam 0.3% Without Treatment Gap	Cohort 2 Groups 3 and 4: ARQ-154-203 Roflumilast Foam 0.3% With Treatment Gap	Cohort 2 Group 4: De Novo Participants	Cohort 1 Group 2: ARQ-154-116 Rollover
Number of Participants With ≥1 Adverse Event (AE)	17	23	90	3

PrimaryNumber 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
Reported as:: Count of participants · Participants

Number of Participants With ≥1 Serious Adverse Event (SAE)
Participants	Cohort 1 Group 1: ARQ-154-203 Roflumilast Foam 0.3% Without Treatment Gap	Cohort 2 Group 3: ARQ-154-203 Roflumilast Foam 0.3% With Treatment Gap	Cohort 2 Group 4: De Novo Participants	Cohort 1 Group 2: ARQ-154-116 Rollover
Number of Participants With ≥1 Serious Adverse Event (SAE)	2	0	5	0

SecondaryNumber 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
Reported as:: Count of participants · Participants

Number of Participants With an Investigator Global Assessment (IGA) Score of Completely Clear or Almost Clear
Participants	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
Week 4	36	7	20	10	137	5
Week 12	35	7	25	12	172	5
Week 24	31	10	24	11	177	3
Week 36	—	—	0	0	37	—
Week 52	—	—	1	1	35	—

SecondaryAchievement 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
Reported as:: Count of participants · Participants

Achievement of IGA Success
Participants	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
Week 4	36	6	20	8	137	5
Week 12	35	7	25	11	172	5
Week 24	31	10	24	11	177	3
Week 36	0	0	0	0	37	0
Week 52	0	0	1	1	35	0

SecondaryDuration 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
Reported as:: Median · weeks

Duration of IGA Success
weeks	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
Duration of IGA Success	18.786 (0.14 to 32.29)	12.143 (0.14 to 22.29)	7.714 (0.14 to 30.43)	13.143 (0.14 to 31.86)	19.00 (0.14 to 50.14)	10.00 (3.57 to 23.71)

SecondaryIGA 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
Reported as:: Median · weeks

IGA Treatment-Free Interval
weeks	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
IGA Treatment-Free Interval	19.143 (0.57 to 24.00)	11.766 (2.57 to 24.43)	11.929 (1.14 to 22.14)	14.143 (2.43 to 22.00)	12.143 (0.29 to 49.14)	20.143 (8.143 to 23.14)

Adverse events

Collected over Up to 52 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Cohort 1 Group 1: ARQ-154-203 Roflumilast Foam 0.3% Without Treatment Gap	0/75 (0%)	2/75 (2.7%)	3/75 (4%)
Cohort 2 Group 3: ARQ-154-203 Roflumilast Foam 0.3% Without Treatment Gap	0/58 (0%)	0/58 (0%)	4/58 (6.9%)
Cohort 2 Group 4: De Novo Participants	1/267 (0.4%)	5/267 (1.9%)	11/267 (4.1%)
Cohort 1 Group 2: ARQ-154-116 Rollover	0/8 (0%)	0/8 (0%)	6/8 (75%)

Most frequent serious events

Most frequent serious events
Event	Cohort 1 Group 1: ARQ-154-203 Roflumilast Foam 0.3% Without Treatment Gap	Cohort 2 Group 3: ARQ-154-203 Roflumilast Foam 0.3% Without Treatment Gap	Cohort 2 Group 4: De Novo Participants	Cohort 1 Group 2: ARQ-154-116 Rollover
Small intestinal obstructionGastrointestinal disorders	1/75	0/58	0/267	0/8
Cerebrovascular accidentNervous system disorders	1/75	0/58	0/267	0/8
Abdominal painGastrointestinal disorders	0/75	0/58	1/267	0/8
Performance status decreasedGeneral disorders	0/75	0/58	1/267	0/8
COVID-19 pneumoniaInfections and infestations	0/75	0/58	1/267	0/8
Brain neoplasm malignantNeoplasms benign, malignant and unspecified (incl cysts and polyps)	0/75	0/58	1/267	0/8
HypertensionVascular disorders	0/75	0/58	1/267	0/8

Most frequent other events

Most frequent other events
Event	Cohort 1 Group 1: ARQ-154-203 Roflumilast Foam 0.3% Without Treatment Gap	Cohort 2 Group 3: ARQ-154-203 Roflumilast Foam 0.3% Without Treatment Gap	Cohort 2 Group 4: De Novo Participants	Cohort 1 Group 2: ARQ-154-116 Rollover
Weight decreasedInvestigations	0/75	0/58	0/267	1/8
TicPsychiatric disorders	0/75	0/58	0/267	1/8
DyspepsiaGastrointestinal disorders	0/75	0/58	0/267	1/8
Application site alopeciaGeneral disorders	0/75	0/58	0/267	1/8
Transaminases increasedInvestigations	0/75	0/58	0/267	1/8
Pyogenic granulomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)	0/75	0/58	0/267	1/8
Urinary tract infectionInfections and infestations	0/75	4/58	3/267	0/8
COVID-19Infections and infestations	3/75	3/58	9/267	0/8

Baseline characteristics

Efficacy data were not summarized for participants from Cohort 1 Group 2.

Age, Continuous
Age, Continuous(years)	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
Mean	44.5 ± 15.99	41.0 ± 15.53	46.7 ± 17.20	48.8 ± 14.99	42.4 ± 16.45	13.5 ± 2.1	42.8 ± 16.8

Sex: Female, Male
Sex: Female, Male(Participants)	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
Female	27	9	21	8	138	4	207
Male	25	14	20	9	129	4	201

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	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
Hispanic or Latino	11	10	8	0	86	6	121
Not Hispanic or Latino	41	13	33	17	179	2	285
Unknown or Not Reported	0	0	0	0	2	0	2

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	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
Asian	3	0	1	0	13	1	18
Black or African-American	5	2	4	2	38	0	51
Native Hawaii or Other Pacific Islander	0	0	0	0	1	0	1
White	42	19	36	15	207	6	325
Other	0	2	0	0	4	0	6
More than one race	2	0	0	0	1	1	4
Missing	0	0	0	0	3	0	3

Investigator Global Assessment (IGA) Baseline Score
Investigator Global Assessment (IGA) Baseline Score(Participants)	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
0 - Completely clear	0	2	0	0	0	0	2
1 = Almost clear	0	7	0	2	0	0	9
2 = Mild	0	2	0	2	0	0	4
3 = Moderate	44	11	38	13	235	5	346
4 = Severe	8	1	3	0	32	3	47

Study locations

39 sites

Arcutis Biotherapeutics Clinical Site 59
Beverly Hills, California 90212, United States
Arcutis Biotherapeutics Clinical Site 51
Encino, California 91436, United States
Arcutis Biotherapeutics Clinical Site 75
Fountain Valley, California 92708, United States
Arcutis Biotherapeutics Clinical Site 19
Fremont, California 94538, United States
Arcutis Biotherapeutics Clinical Site 62
Los Angeles, California 90036, United States
Arcutis Biotherapeutics Clinical Site 64
San Diego, California 92123, United States
Arcutis Biotherapeutics Clinical Site 21
Santa Monica, California 90404, United States
Arcutis Biotherapeutics Clinical Site 53
Aventura, Florida 33180, United States
Arcutis Biotherapeutics Clinical Site 42
Coral Gables, Florida 33134, United States
Arcutis Biotherapeutics Clinical Site 57
Delray Beach, Florida 33484, United States
Arcutis Biotherapeutics Clinical Site 24
Miami, Florida 33144, United States
Arcutis Biotherapeutics Clinical Site 65
Sanford, Florida 32771, United States
Arcutis Biotherapeutics Clinical Site 12
Tampa, Florida 33613, United States
Arcutis Biotherapeutics Clinical Site 10
Rolling Meadows, Illinois 60008, United States
Arcutis Biotherapeutics Clinical Site 22
Plainfield, Indiana 46168, United States
Arcutis Biotherapeutics Clinical Site 15
Louisville, Kentucky 40217, United States
Arcutis Biotherapeutics Clinical Site 52
Metairie, Louisiana 70006, United States
Arcutis Biotherapeutics Clinical Site 28
Rockville, Maryland 20850, United States
Arcutis Biotherapeutics Clinical Site 73
Brighton, Massachusetts 02135, United States
Arcutis Biotherapeutics Clinical Site 40
Clinton Township, Michigan 48038, United States
Arcutis Biotherapeutics Clinical Site 20
Detroit, Michigan 48202, United States
Arcutis Biotherapeutics Clinical Site 58
Fort Gratiot, Michigan 48059, United States
Arcutis Biotherapeutics Clinical Site 14
Fridley, Minnesota 55432, United States
Arcutis Biotherapeutics Clinical Site 50
Las Vegas, Nevada 89148, United States
Arcutis Biotherapeutics Clinical Site 56
Portsmouth, New Hampshire 03801, United States
Arcutis Biotherapeutics Clinical Site 63
Bronx, New York 10462, United States
Arcutis Biotherapeutics Clinical Site 55
New York, New York 10029, United States
Arcutis Biotherapeutics Clinical Site 23
High Point, North Carolina 27262, United States
Arcutis Biotherapeutics Clinical Site 18
Bexley, Ohio 43209, United States
Arcutis Biotherapeutics Clinical Site 29
Portland, Oregon 97210, United States
Arcutis Biotherapeutics Clinical Site 27
Pittsburgh, Pennsylvania 15213, United States
Arcutis Biotherapeutics Clinical Site 76
Charleston, South Carolina 29407, United States
Arcutis Biotherapeutics Clinical Site 13
Arlington, Texas 76011, United States
Arcutis Biotherapeutics Clinical Site 11
Austin, Texas 78759, United States
Arcutis Biotherapeutics Clinical Site 41
College Station, Texas 77845, United States
Arcutis Biotherapeutics Clinical Site 25
Houston, Texas 77056, United States
Arcutis Biotherapeutics Clinical Site 26
Pflugerville, Texas 78660, United States
Arcutis Biotherapeutics Clinical Site 54
San Antonio, Texas 78213, United States
Arcutis Biotherapeutics Clinical Site 17
Norfolk, Virginia 23502, United States

References and documents

Study documents

Study protocol · Nov 4, 2021
Statistical analysis plan · Feb 18, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 11, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04445987
Lead sponsor: Arcutis Biotherapeutics, Inc.
Responsible party: Sponsor
First posted: Jun 24, 2020
Start date: Jun 12, 2020
Primary completion: Nov 19, 2022
Completion: Nov 19, 2022
Results posted: Jun 11, 2024
Last update: Jun 11, 2024

Study contacts

David Berk, MD

study director · Arcutis Biotherapeutics

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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