Seborrheic DermatitisPhase 3NCT04973228
Trial of PDE4 Inhibition With Roflumilast (ARQ-154) Foam 0.3% for the Management of Seborrheic Dermatitis (STRATUM)
A Phase 3 study testing Roflumilast Foam in people with Seborrheic Dermatitis, run by Arcutis Biotherapeutics, Inc. at 53 sites in 2 countries.
Trial summary
This phase 3, double-blind, vehicle-controlled study assessed the safety and efficacy of roflumilast (ARQ-154) foam 0.3% applied once daily (qd) for 8 weeks by participants with seborrheic dermatitis. Read more about this study
- Who is it for?
- Ages 9 years and older
- Conditions the study is for
- Seborrheic Dermatitis
- What is being tested?
- Roflumilast Foam
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 457 participants
- Where
- 53 sitesin 2 countries
- Study dates
- 8 Jul 2021to 6 Apr 2022
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participants legally competent to sign and give informed consent and, if appropriate, assent as required by local laws.
- Males and females ages 9 years and older at the time of consent.
- Clinical diagnosis of seborrheic dermatitis of at least 3 months duration at Screening as determined by the Investigator. Stable disease for the past 4 weeks.
- Seborrheic dermatitis up to 20% BSA involvement. Involvement may be of the scalp and/or face and/or trunk and/or intertriginous areas.
- An Investigator Global Assessment (IGA) disease severity of at least Moderate ('3') at Baseline.
- Overall Assessment of Erythema and Overall Assessment of Scaling scores of at least Moderate ('2') at Baseline.
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- Females of childbearing potential (FOCBP) must have a negative serum pregnancy test at Screening (Visit 1) and a negative urine pregnancy test at Baseline (Visit 2).
- Females of non-childbearing potential must either be post-menopausal with spontaneous amenorrhea for at least 12 months or have undergone surgical sterilization.
- Subjects in good health as judged by the Investigator.
- Subjects are considered reliable and capable of adhering to the Protocol and visit schedule according to the Investigator judgment.
Who cannot join
- Subjects who cannot discontinue treatment with therapies for the treatment of seborrheic dermatitis prior to the Baseline visit and during the study.
- Planned excessive exposure of treated area(s) to either natural or artificial sunlight, tanning bed or other LED.
- Previous treatment with ARQ-154 or ARQ-151.
- Subjects with any serious medical condition or clinically significant abnormality that would prevent study participation or place the subject at significant risk, as judged by the Investigator.
- Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
- Subjects with a history of chronic alcohol or drug abuse within 6 months prior to Screening.
- Subjects, parent(s)/legal guardian(s) who are unable to communicate, read, or understand the local language(s).
- Subjects who are family members of the clinical study site, clinical study staff, or sponsor, or family members living in the same house of enrolled subjects.
Trial locations and contacts
53 sites in 2 countries.
53 sites in 2 countries
United States43 sites
Arcutis Biotherapeutics Clinical Site 13
Arlington, Texas, 76011
Arcutis Biotherapeutics Clinical Site 11
Austin, Texas, 78759
Arcutis Biotherapeutics Clinical Site 18
Bexley, Ohio, 43209
Arcutis Biotherapeutics Clinical Site 08
Broomall, Pennsylvania, 19008
Arcutis Biotherapeutics Clinical Site 40
Clinton Township, Michigan, 48038
Arcutis Biotherapeutics Clinical Site 41
College Station, Texas, 77845
Arcutis Biotherapeutics Clinical Site 42
Coral Gables, Florida, 33134
Arcutis Biotherapeutics Clinical Site 57
Delray Beach, Florida, 33484
Arcutis Biotherapeutics Clinical Site 20
Detroit, Michigan, 48202
Arcutis Biotherapeutics Clinical Site 34
East Windsor, New Jersey, 08520
Arcutis Biotherapeutics Clinical Site 45
Encinitas, California, 92024
Arcutis Biotherapeutics Clinical Site 14
Fridley, Minnesota, 55432
Arcutis Biotherapeutics Clinical Site 23
High Point, North Carolina, 27262
Arcutis Biotherapeutics Clinical Site 60
Houston, Texas, 77030
Arcutis Biotherapeutics Clinical Site 03
Indianapolis, Indiana, 46250
Arcutis Biotherapeutics Clinical Site 06
Knoxville, Tennessee, 37922
Arcutis Biotherapeutics Clinical Site 04
Lake Charles, Louisiana, 70605
Arcutis Biotherapeutics Clinical Site 33
Largo, Florida, 33770
Arcutis Biotherapeutics Clinical Site 15
Louisville, Kentucky, 40217
Arcutis Biotherapeutics Clinical Site 66
New York, New York, 10065
Arcutis Biotherapeutics Clinical Site 17
Norfolk, Virginia, 23502
Arcutis Biotherapeutics Clinical Site 31
North Miami Beach, Florida, 33162
Arcutis Biotherapeutics Clinical Site 26
Pflugerville, Texas, 78660
Arcutis Biotherapeutics Clinical Site 27
Pittsburgh, Pennsylvania, 15213
Arcutis Biotherapeutics Clinical Site 22
Plainfield, Indiana, 46168
Arcutis Biotherapeutics Clinical Site 72
Plano, Texas, 75024
Arcutis Biotherapeutics Clinical Site 71
Portland, Oregon, 97223
Arcutis Biotherapeutics Clinical Site 19
Reno, Nevada, 89509
Arcutis Biotherapeutics Clinical Site 02
Rockville, Maryland, 20850
Arcutis Biotherapeutics Clinical Site 28
Rockville, Maryland, 20850
Arcutis Biotherapeutics Clinical Site 10
Rolling Meadows, Illinois, 60008
Arcutis Biotherapeutics Clinical Site 44
Saint Joseph, Missouri, 64506
Arcutis Biotherapeutics Clinical Site 54
San Antonio, Texas, 78213
Arcutis Biotherapeutics Clinical Site 24
San Antonio, Texas, 78218
Arcutis Biotherapeutics Clinical Site 46
San Diego, California, 92123
Arcutis Biotherapeutics Clinical Site 64
San Diego, California, 92123
Arcutis Biotherapeutics Clinical Site 65
Sanford, Florida, 32771
Arcutis Biotherapeutics Clinical Site 21
Santa Monica, California, 90404
Arcutis Biotherapeutics Clinical Site 01
Scottsdale, Arizona, 85255
Arcutis Biotherapeutics Clinical Site 12
Tampa, Florida, 33613
Arcutis Biotherapeutics Clinical Site 63
The Bronx, New York, 10462
Arcutis Biotherapeutics Clinical Site 07
West Jordan, Utah, 84088
Arcutis Biotherapeutics Clinical Site 70
Winston-Salem, North Carolina, 27104
Canada10 sites
Arcutis Biotherapeutics Clinical Site 35
Calgary, Alberta, T2J 7E1
Arcutis Biotherapeutics Clinical Site 43
Fredericton, New Brunswick, E3B 1G9
Arcutis Biotherapeutics Clinical Site 16
London, Ontario, N6H 5L5
Arcutis Biotherapeutics Clinical Site 29
Mississauga, Ontario, L5H 1G9
Arcutis Biotherapeutics Clinical Site 30
North Bay, Ontario, P1B 3Z7
Arcutis Biotherapeutics Clinical Site 32
Peterborough, Ontario, K9J 5K2
Arcutis Biotherapeutics Clinical Site 37
Surrey, British Columbia, V3V 0C6
Arcutis Biotherapeutics Clinical Site 36
Waterloo, Ontario, N2J 1C4
Arcutis Biotherapeutics Clinical Site 09
Westmount, Quebec, H3Z 2S6
Arcutis Biotherapeutics Clinical Site 47
Winnipeg, Manitoba, R3M 3Z4
About this study
Official title: A Phase 3, 8-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-154 Foam 0.3% Administered QD in Subjects With Seborrheic Dermatitis
This phase 3, double-blind, vehicle-controlled study assessed the safety and efficacy of roflumilast (ARQ-154) foam 0.3% applied once daily (qd) for 8 weeks by participants with seborrheic dermatitis.
- Conditions
- Seborrheic Dermatitis
- Being tested
- Roflumilast Foam, Vehicle Foam
- Medical subject headings
- Dermatitis, Seborrheic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Roflumilast FoamDrug
Also called ARQ-154
Roflumilast 0.3% foam for topical application
Vehicle FoamDrug
Vehicle foam for topical application
| Study group | Role | What they receive |
|---|---|---|
| Roflumilast Foam 0.3% | Experimental | Participants with seborrheic dermatitis apply roflumilast foam 0.3% once daily (QD) for 8 weeks. Receives: Drug: Roflumilast Foam |
| Vehicle Foam | Placebo comparator | Participants with seborrheic dermatitis apply vehicle foam QD for 8 weeks. Receives: Drug: Vehicle Foam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achievement of Success on the Investigator Global Assessment (IGA) at Week 8
The percentage of participants achieving IGA "success" is presented. Success is defined as a score of 0 ('clear') or 1 ('almost clear') plus a 2-point improvement at Week 8. The IGA is 5-point scale assessing the severity of seborrheic dermatitis with total scores ranging from 0 ('clear') to 4 ('severe') [higher scores indicating greater severity].
Measured: Week 8
Secondary outcomes (7)
Achievement of Success in the Worst Itch Numeric Rating Scale (WI-NRS) at Week 8
The percentage of participants achieving WI-NRS "success" is presented. The WI-NRS is a simple, single-item scale to assess the participant-reported severity of this symptom, on a scale ranging from 0 ("no itch") to 10 ("worst imaginable itch") the participants experienced in the previous 24 hours (higher scores indicate higher itch severity). The endpoint is the average of daily assessments reported during each study week, and requires at least 4 daily assessments reported during the week. In participants with a weekly average baseline pruritus score of ≥4, "success" is defined as achievement of a ≥4-point improvement from baseline in weekly average WI-NRS pruritus score at Week 8.
Measured: Week 8
Achievement of Success in the WI-NRS at Week 4
The percentage of participants achieving WI-NRS "success" is presented. The WI-NRS is a simple, single-item scale to assess the participant-reported severity of this symptom, on a scale ranging from 0 ("no itch") to 10 ("worst imaginable itch") the participants experienced in the previous 24 hours (higher scores indicate higher itch severity). The endpoint is the average of daily assessments reported during each study week, and requires at least 4 daily assessments reported during the week. In participants with a weekly average baseline pruritus score of ≥4, "success" is defined as achievement of a ≥4-point improvement from baseline in weekly average WI-NRS pruritus score at Week 4.
Measured: Week 4
Achievement of Success in the WI-NRS at Week 2
The percentage of participants achieving WI-NRS "success" is presented. In participants with a weekly average baseline pruritus score of ≥4, "success" is defined as achievement of a ≥4-point improvement from baseline in weekly average WI-NRS pruritus score at Week 2. The endpoint is the average of daily assessments reported during each study week, and requires at least 4 daily assessments reported during the week. The WI-NRS is a simple, single-item scale to assess the participant-reported severity of this symptom, on a scale ranging from 0 ("no itch") to 10 ("worst imaginable itch") the participants experienced in the previous 24 hours (higher scores indicate higher itch severity).
Measured: Week 2
Achievement of Success on the IGA at Week 2
The percentage of participants achieving WI-NRS "success" is presented. The WI-NRS is a simple, single-item scale to assess the participant-reported severity of this symptom, on a scale ranging from 0 ("no itch") to 10 ("worst imaginable itch") the participants experienced in the previous 24 hours (higher scores indicate higher itch severity). The endpoint is the average of daily assessments reported during each study week, and requires at least 4 daily assessments reported during the week. In participants with a weekly average baseline pruritus score of ≥4, "success" is defined as achievement of a ≥4-point improvement from baseline in weekly average WI-NRS pruritus score at Week 2.
Measured: Week 2
Achievement of Success on the IGA at Week 4
The percentage of participants achieving IGA "success" is presented. Success is defined as a score of 0 ('clear') or 1 ('almost clear') plus a 2-point improvement at Week 8. The IGA is 5-point scale assessing the severity of seborrheic dermatitis with total scores ranging from 0 ('clear') to 4 ('severe') [higher scores indicating greater severity].
Measured: Week 4
Achievement of Overall Assessment of Scaling Score of 0 at Week 8
The percentage of participants achieving Overall Assessment of Scaling score of 0 at Week 8 is presented. The Overall Assessment of Scaling is a simple, single-item scale to assess the subject-reported severity of this symptom, on a scale ranging from 0 ("No scaling: No scaling evident on lesions.") to 3 ("Severe: Coarse, thick scales, with flaking into clothes or skin."). Higher scores indicate greater symptom severity.
Measured: Week 8
Achievement of Overall Assessment of Erythema Score of 0 at Week 8
The percentage of participants achieving Overall Assessment of Erythema score of 0 at Week 8 is presented. The Erythema Assessment is a simple, single-item scale to assess the subject-reported severity of this symptom, on a scale ranging from 0 ("None: no evidence of erythema.") to 3 ("Severe: Intense [fiery red] erythema."). Higher scores indicate greater severity.
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start8 Jul 2021
- Primary completion6 Apr 2022
- Study completion6 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Seborrheic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 457 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arcutis Biotherapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Berk, MD, Study director, Arcutis Biotherapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04973228
- Sponsor's protocol ID
- ARQ-154-304
- Status last verified
- Feb 2024
- First submitted
- 13 Jul 2021
- Last updated
- 12 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, 8-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-154 Foam 0.3% Administered QD in Subjects With Seborrheic Dermatitis
- ClinicalTrials.gov ID
- NCT04973228
- Acronym / sponsor ID
- ARQ-154-304
- Conditions
- Seborrheic Dermatitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 457 participants (actual)
- Lead sponsor
- Arcutis Biotherapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Jul 2021 (actual)
- Primary completion
- 6 Apr 2022 (actual)
- Study completion
- 6 Apr 2022 (actual)
- First posted
- 22 Jul 2021 (actual)
- Results
- Posted 12 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase 3, double-blind, vehicle-controlled study assessed the safety and efficacy of roflumilast (ARQ-154) foam 0.3% applied once daily (qd) for 8 weeks by participants with seborrheic dermatitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Roflumilast Foam 0.3% | Experimental | Drug: Roflumilast FoamParticipants with seborrheic dermatitis apply roflumilast foam 0.3% once daily (QD) for 8 weeks. |
| Vehicle Foam | Placebo comparator | Drug: Vehicle FoamParticipants with seborrheic dermatitis apply vehicle foam QD for 8 weeks. |
Who may qualify
- Ages
- 9 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Participants legally competent to sign and give informed consent and, if appropriate, assent as required by local laws.
- Males and females ages 9 years and older at the time of consent.
- Clinical diagnosis of seborrheic dermatitis of at least 3 months duration at Screening as determined by the Investigator. Stable disease for the past 4 weeks.
- Seborrheic dermatitis up to 20% BSA involvement. Involvement may be of the scalp and/or face and/or trunk and/or intertriginous areas.
- An Investigator Global Assessment (IGA) disease severity of at least Moderate ('3') at Baseline.
Key exclusion criteria (8 listed)
- Subjects who cannot discontinue treatment with therapies for the treatment of seborrheic dermatitis prior to the Baseline visit and during the study.
- Planned excessive exposure of treated area(s) to either natural or artificial sunlight, tanning bed or other LED.
- Previous treatment with ARQ-154 or ARQ-151.
- Subjects with any serious medical condition or clinically significant abnormality that would prevent study participation or place the subject at significant risk, as judged by the Investigator.
- Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Roflumilast FoamAlso: ARQ-154Roflumilast 0.3% foam for topical application | Drug | Roflumilast Foam 0.3% |
| Vehicle FoamVehicle foam for topical application | Drug | Vehicle Foam |
Primary outcome
Achievement of Success on the Investigator Global Assessment (IGA) at Week 8
Time frame: Week 8
The percentage of participants achieving IGA "success" is presented. Success is defined as a score of 0 ('clear') or 1 ('almost clear') plus a 2-point improvement at Week 8. The IGA is 5-point scale assessing the severity of seborrheic dermatitis with total scores ranging from 0 ('clear') to 4 ('severe') [higher scores indicating greater severity].
7 secondary outcomes
Achievement of Success in the Worst Itch Numeric Rating Scale (WI-NRS) at Week 8
Time frame: Week 8
Achievement of Success in the WI-NRS at Week 4
Time frame: Week 4
Achievement of Success in the WI-NRS at Week 2
Time frame: Week 2
Achievement of Success on the IGA at Week 2
Time frame: Week 2
Achievement of Success on the IGA at Week 4
Time frame: Week 4
Achievement of Overall Assessment of Scaling Score of 0 at Week 8
Time frame: Week 8
Achievement of Overall Assessment of Erythema Score of 0 at Week 8
Time frame: Week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Berk, MD study director
Arcutis Biotherapeutics, Inc.
53 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Roflumilast Foam in people with Seborrheic Dermatitis, run by Arcutis Biotherapeutics, Inc. at 53 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 53 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Achievement of Success on the Investigator Global Assessment (IGA) at Week 8 (time frame: Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.