Seborrheic DermatitisPhase 2NCT04091646
Safety and Efficacy of ARQ-154 Foam in Subjects With Seborrheic Dermatitis
A Phase 2 study testing Roflumilast Foam 0.3% in people with Seborrheic Dermatitis, run by Arcutis Biotherapeutics, Inc. at 24 sites in 2 countries.
Trial summary
This was a parallel group, double blind, vehicle-controlled study assessed the safety and efficacy of roflumilast foam (ARQ-154) vs placebo foam in participants with seborrheic dermatitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Seborrheic Dermatitis
- What is being tested?
- Roflumilast Foam 0.3%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 226 participants
- Where
- 24 sitesin 2 countries
- Study dates
- 4 Dec 2019to 21 Aug 2020
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants legally competent to sign and give informed consent.
- Males and females ages 18 years and older (inclusive) at the time of consent.
- 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.
- An Investigator Global Assessment (IGA) of 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, based on medical history, physical examination, vital signs, serum chemistry labs, hematology values, and urinalysis.
- 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 according to Excluded Medications and Treatments.
- Planned excessive exposure of treated area(s) to either natural or artificial sunlight, tanning bed or other LED.
- 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 for two weeks prior to the Baseline visit (Visit 2) and during the study.
- Subjects who cannot discontinue the use of strong P-450 cytochrome inducers e.g., efavirenz, nevirapine, glucocorticoids, barbiturates (including phenobarbital), phenytoin, rifampin, and carbamazepine for two weeks prior to the Baseline visit (Visit 2) and during the study.
- Subjects with PHQ-8 ≥10 at Screening or Baseline visits.
- Previous treatment with ARQ-151 and ARQ-154.
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- Subjects who have received oral roflumilast (Daliresp®, Daxas®) or other PDE-4 inhibitors (apremilast) within the past 4 weeks.
- Known allergies to excipients in ARQ-154 foam.
- Known or suspected: severe renal insufficiency or moderate to severe hepatic disorders; hypersensitivity to component(s) of the investigational products; or history of severe depression, suicidal ideation, or Baseline/Screening C-SSRS indicative of suicidal ideation, whether lifetime or recent/current.
- Subjects with a history of a major surgery within 8 weeks prior to Baseline (Visit 2) or has a major surgery planned during the study.
- Subjects with any condition on the treatment area which, in the opinion of the Investigator, could confound efficacy measurements.
- Subjects unable to apply product to the scalp due to physical limitations.
- Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
- A clinically relevant history of abuse of alcohol or other drugs, at the discretion of the Investigator.
- 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 of enrolled subjects.
- Any condition that in the Investigator's assessment would preclude the subject from participating in the study.
Trial locations and contacts
24 sites in 2 countries.
24 sites in 2 countries
United States22 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 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 20
Detroit, Michigan, 48202
Arcutis Biotherapeutics Clinical Site 19
Fremont, California, 94538
Arcutis Biotherapeutics Clinical Site 14
Fridley, Minnesota, 55432
Arcutis Biotherapeutics Clinical Site 23
High Point, North Carolina, 27262
Arcutis Biotherapeutics Clinical Site 25
Houston, Texas, 77056
Arcutis Biotherapeutics Clinical Site 15
Louisville, Kentucky, 40217
Arcutis Biotherapeutics Clinical Site 24
Miami, Florida, 33144
Arcutis Biotherapeutics Clinical Site 17
Norfolk, Virginia, 23502
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 29
Portland, Oregon, 97210
Arcutis Biotherapeutics Clinical Site 28
Rockville, Maryland, 20850
Arcutis Biotherapeutics Clinical Site 10
Rolling Meadows, Illinois, 60008
Arcutis Biotherapeutics Clinical Site 21
Santa Monica, California, 90404
Arcutis Biotherapeutics Clinical Site 12
Tampa, Florida, 33613
Canada2 sites
Arcutis Biotherapeutics Clinical Site 31
Markham, Ontario, L3P 1X2
Arcutis Biotherapeutics Clinical Site 30
Windsor, Ontario, N8W 1E6
About this study
Official title: A Phase 2b, 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 was a parallel group, double blind, vehicle-controlled study assessed the safety and efficacy of roflumilast foam (ARQ-154) vs placebo foam in participants with seborrheic dermatitis.
- Conditions
- Seborrheic Dermatitis
- Being tested
- Roflumilast Foam 0.3%, 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 Foam 0.3%Drug
Also called ARQ-154
Roflumilast foam for topical application.
Vehicle foamDrug
Also called Placebo
Vehicle foam for topical application.
| Study group | Role | What they receive |
|---|---|---|
| Roflumilast Foam 0.3% | Active comparator | Participants apply roflumilast foam 0.3% once daily (QD) to all areas of seborrheic dermatitis once daily for 8 weeks. Receives: Drug: Roflumilast Foam 0.3% |
| Vehicle Foam | Placebo comparator | Participants apply inactive vehicle foam matched to roflumilast 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 Investigator Global Assessment (IGA) Success at Week 8
The number of participants achieving "success" in IGA assessment of disease severity at Week 8 is presented for each arm. Success was defined as achievement of an IGA score of 0 ('completely clear') or 1 ('almost clear'), accompanied by a ≥2-grade improvement from baseline IGA score. The IGA is 5-point scale assessing the severity of Seborrheic Dermatitis, with scores ranging from 0 ('completely clear') to 4 ('severe'), and higher scores indicate greater severity. The IGA scores are based on observed data, whereas odds ratio and p-values were calculated using multiple imputation of missing values.
Measured: Week 8
Secondary outcomes (7)
Achievement of IGA Success at Weeks 2 and 4
The number of participants achieving "success" in IGA assessment of disease severity at Weeks 2 and 4 is presented for each arm. Success was defined as achievement of an IGA score of 0 ('completely clear') or 1 ('almost clear'), accompanied by a ≥2-grade improvement from baseline IGA score. The IGA is 5-point scale assessing the severity of Seborrheic Dermatitis, with scores ranging from 0 ('completely clear') to 4 ('severe'), and higher scores indicate greater severity. The IGA scores are based on observed data, whereas odds ratio and p-values were calculated using multiple imputation of missing values.
Measured: Weeks 2 and 4
Change From Baseline in Overall Assessment of Erythema Score
The mean (SD) change from baseline in Overall Assessment of Erythema score at Weeks 2, 4, and 8 is shown. 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: Weeks 2, 4, and 8
Achievement of Overall Assessment of Erythema Success
The number of participants achieving "success" in Overall Assessment of Erythema at Weeks 2, 4, and 8 is presented for each arm. Success was defined as achievement of an overall score of 0 or 1 plus a ≥2 grade improvement from Baseline. The Overall Assessment of Erythema 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: Weeks 2, 4, and 8
Change From Baseline in Overall Assessment of Scaling Score
The mean (SD) change from baseline in Overall Assessment of Scaling score at Weeks 2, 4, and 8 is shown. 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 severity.
Measured: Weeks 2, 4, and 8
Achievement of Overall Assessment of Scaling Success
The number of participants achieving "success" in Overall Assessment of Scaling score at Weeks 2, 4, and 8 is presented for each arm. Success was defined as achievement of an Overall Assessment of Scaling score of 0 or 1 plus a ≥2 grade improvement from Baseline. 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 severity.
Measured: Weeks 2, 4, and 8
Change From Baseline in Worst Itch Numeric Rating Scale (WI-NRS) Score
The change from baseline in WI-NRS is shown. The WI-NRS is a simple, single-item scale to assess the subject-reported severity of this symptom, on a scale ranging from 0 ("no itch") to 10 ("worst imaginable itch") the subject experienced in the previous 24 hours. Negative values represent a decrease in worst itch from baseline, and positive values indicate an increase.
Measured: Weeks 2, 4, and 8
Achievement of WI-NRS Success
The number of participants achieving WI-NRS "success" at Weeks 2, 4, and 8 is presented. Success was defined as achievement of a ≥4-point improvement from baseline WI-NRS score. The WI-NRS is a simple, single-item scale to assess the subject-reported severity of this symptom, on a scale ranging from 0 ("no itch") to 10 ("worst imaginable itch") the subject experienced in the previous 24 hours.
Measured: Weeks 2, 4, and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2019
- Study start4 Dec 2019
- Primary completion18 Aug 2020
- Study completion21 Aug 2020
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 226 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
- NCT04091646
- Sponsor's protocol ID
- ARQ-154-203
- Status last verified
- Jun 2023
- First submitted
- 13 Sep 2019
- Last updated
- 3 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zirwas MJ, Draelos ZD, DuBois J, Kircik LH, Moore AY, Stein Gold L, Alonso-Llamazares J, Bukhalo M, Bruce S, Eads K, Green LJ, Guenthner ST, Ferris LK, Forman SB, Kempers SE, Lain E, Lynde CW, Pariser DM, Toth DP, Yamauchi PS, Higham RC, Krupa D, Burnett P, Berk DR. Efficacy of Roflumilast Foam, 0.3%, in Patients With Seborrheic Dermatitis: A Double-blind, Vehicle-Controlled Phase 2a Randomized Clinical Trial. JAMA Dermatol. 2023 Jun 1;159(6):613-620. doi: 10.1001/jamadermatol.2023.0846.
PubMed 37133856
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b, 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
- NCT04091646
- Acronym / sponsor ID
- ARQ-154-203
- Conditions
- Seborrheic Dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 226 participants (actual)
- Lead sponsor
- Arcutis Biotherapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Dec 2019 (actual)
- Primary completion
- 18 Aug 2020 (actual)
- Study completion
- 21 Aug 2020 (actual)
- First posted
- 17 Sep 2019 (actual)
- Results
- Posted 3 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was a parallel group, double blind, vehicle-controlled study assessed the safety and efficacy of roflumilast foam (ARQ-154) vs placebo foam in 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% | Active comparator | Drug: Roflumilast Foam 0.3%Participants apply roflumilast foam 0.3% once daily (QD) to all areas of seborrheic dermatitis once daily for 8 weeks. |
| Vehicle Foam | Placebo comparator | Drug: Vehicle foamParticipants apply inactive vehicle foam matched to roflumilast foam QD for 8 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Participants legally competent to sign and give informed consent.
- Males and females ages 18 years and older (inclusive) at the time of consent.
- 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.
- An Investigator Global Assessment (IGA) of disease severity of at least Moderate ('3') at Baseline.
Key exclusion criteria (17 listed)
- Subjects who cannot discontinue treatment with therapies for the treatment of seborrheic dermatitis prior to the Baseline visit and during the study according to Excluded Medications and Treatments.
- Planned excessive exposure of treated area(s) to either natural or artificial sunlight, tanning bed or other LED.
- 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 for two weeks prior to the Baseline visit (Visit 2) and during the study.
- Subjects who cannot discontinue the use of strong P-450 cytochrome inducers e.g., efavirenz, nevirapine, glucocorticoids, barbiturates (including phenobarbital), phenytoin, rifampin, and carbamazepine for two weeks prior to the Baseline visit (Visit 2) and during the study.
- Subjects with PHQ-8 ≥10 at Screening or Baseline visits.
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 Foam 0.3%Also: ARQ-154Roflumilast foam for topical application. | Drug | Roflumilast Foam 0.3% |
| Vehicle foamAlso: PlaceboVehicle foam for topical application. | Drug | Vehicle Foam |
Primary outcome
Achievement of Investigator Global Assessment (IGA) Success at Week 8
Time frame: Week 8
The number of participants achieving "success" in IGA assessment of disease severity at Week 8 is presented for each arm. Success was defined as achievement of an IGA score of 0 ('completely clear') or 1 ('almost clear'), accompanied by a ≥2-grade improvement from baseline IGA score. The IGA is 5-point scale assessing the severity of Seborrheic Dermatitis, with scores ranging from 0 ('completely clear') to 4 ('severe'), and higher scores indicate greater severity. The IGA scores are based on observed data, whereas odds ratio and p-values were calculated using multiple imputation of missing values.
7 secondary outcomes
Achievement of IGA Success at Weeks 2 and 4
Time frame: Weeks 2 and 4
Change From Baseline in Overall Assessment of Erythema Score
Time frame: Weeks 2, 4, and 8
Achievement of Overall Assessment of Erythema Success
Time frame: Weeks 2, 4, and 8
Change From Baseline in Overall Assessment of Scaling Score
Time frame: Weeks 2, 4, and 8
Achievement of Overall Assessment of Scaling Success
Time frame: Weeks 2, 4, and 8
Change From Baseline in Worst Itch Numeric Rating Scale (WI-NRS) Score
Time frame: Weeks 2, 4, and 8
Achievement of WI-NRS Success
Time frame: Weeks 2, 4, and 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37133856Zirwas MJ, Draelos ZD, DuBois J, Kircik LH, Moore AY, Stein Gold L, Alonso-Llamazares J, Bukhalo M, Bruce S, Eads K, Green LJ, Guenthner ST, Ferris LK, Forman SB, Kempers SE, Lain E, Lynde CW, Pariser DM, Toth DP, Yamauchi PS, Higham RC, Krupa D, Burnett P, Berk DR. Efficacy of Roflumilast Foam, 0.3%, in Patients With Seborrheic Dermatitis: A Double-blind, Vehicle-Controlled Phase 2a Randomized Clinical Trial. JAMA Dermatol. 2023 Jun 1;159(6):613-620. doi: 10.1001/jamadermatol.2023.0846.
- 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.
24 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Roflumilast Foam 0.3% in people with Seborrheic Dermatitis, run by Arcutis Biotherapeutics, Inc. at 24 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 17 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 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 3 Jul 2023). 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 Investigator Global Assessment (IGA) Success 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?
On the ClinicalTrials.gov record for NCT04091646, which also lists 1 linked publication.
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 3 Jul 2023.