Scalp PsoriasisPhase 3ARRECTORNCT05028582
Topical Roflumilast to Treat Scalp and Body Psoriasis (ARRECTOR)
A Phase 3 study testing Roflumilast Foam 0.3% in people with Scalp Psoriasis, run by Arcutis Biotherapeutics, Inc. at 49 sites in 2 countries.
Trial summary
This was a parallel group, double blind, vehicle-controlled study to assess the safety and efficacy of roflumilast (ARQ-154) 0.3% foam vs vehicle foam applied once daily (qd) for 8 weeks by participants with plaque psoriasis of the scalp and body. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Scalp Psoriasis
- What is being tested?
- Roflumilast Foam 0.3%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 432 participants
- Where
- 49 sitesin 2 countries
- Study dates
- 24 Aug 2021to 3 Jun 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- For adult subjects: Participants legally competent to read, write, and sign and give informed consent. For adolescent subjects: Informed consent of a parent(s) or legal guardian, and assent by the subjects, as required by local laws.
- Males and females ages 12 years and older (inclusive) at the time of consent or assent.
- Scalp psoriasis with a Scalp-Investigator Global Assessment of Disease (S IGA) severity of at least Moderate ('3') at Baseline.
- Extent of scalp psoriasis involving ≥ 10% of the total scalp at Baseline.
- A Psoriasis Scalp Severity Index (PSSI) of at least 6 at Baseline.
- An IGA of body (i.e., non-scalp) psoriasis (B-IGA) of at least Mild ('2') at Baseline.
Show all 12Show fewer
- A PASI score of at least 2 (excluding palms and soles) at Baseline.
- Clinical diagnosis of psoriasis vulgaris of at least 6 months duration at Screening as determined by the Investigator. Stable disease for the past 4 weeks.
- Total overall psoriasis involvement on scalp and non-scalp areas ≤ 25% BSA (not including palms/soles) at Baseline. Total non-scalp BSA should not exceed 20%.
- Female subject of childbearing potential (FOCBP) must have a negative serum pregnancy test at Screening (Visit 1) and negative urine pregnancy test at Baseline (Visit 2). In addition, sexually active FOCBP must agree to use at least one form of highly effective contraception or a barrier method of contraception throughout the study according to Contraception Requirements for the protocol.
- Females of non-childbearing potential must either be premenarchal, post-menopausal with spontaneous amenorrhea for at least 12 months (post-menopausal status will be confirmed with FSH testing) or have undergone surgical sterilization according to Contraception Requirements for the protocol. Prepubescent females must agree to be abstinent during the study.
- Subjects in good health as judged by the Investigator, based on medical history, physical examination, vital signs, serum chemistry labs, hematology values, and urinalysis.
Who cannot join
- Subjects who cannot discontinue treatment with therapies for the treatment of psoriasis vulgaris prior to the Baseline visit and during the study.
- Planned excessive exposure to treated area(s) to either natural or artificial sunlight, tanning bed, or other LED.
- Previous treatment with ARQ-151 or ARQ-154.
- 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 who are family members of the clinical study site, clinical study staff, or sponsor, or family members residing in the same household of enrolled subjects.
- Any condition that in the Investigator's assessment would preclude the subject from participating in the study.
Trial locations and contacts
49 sites in 2 countries.
49 sites in 2 countries
United States36 sites
Arcutis Biotherapeutics Clinical Site 13
Arlington, Texas, 76011
Arcutis Biotherapeutics Clinical Site 11
Austin, Texas, 78759
Arcutis Biotherapeutics Clinical Site 50
Beverly Hills, California, 90212
Arcutis Biotherapeutics Clinical Site 33
Clearwater, Florida, 33756
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 23
High Point, North Carolina, 27262
Arcutis Biotherapeutics Clinical Site 06
Knoxville, Tennessee, 37922
Arcutis Biotherapeutics Clinical Site 04
Lake Charles, Louisiana, 70605
Arcutis Biotherapeutics Clinical Site 15
Louisville, Kentucky, 40217
Arcutis Biotherapeutics Clinical Site 14
New Brighton, Minnesota, 55112
Arcutis Biotherapeutics Clinical Site 17
Norfolk, Virginia, 23502
Arcutis Biotherapeutics Clinical Site 31
North Miami Beach, Florida, 33162
Arcutis Biotherapeutics Clinical Site 05
Orlando, Florida, 32819
Arcutis Biotherapeutics Clinical Site 27
Pittsburgh, Pennsylvania, 15213
Arcutis Biotherapeutics Clinical Site 22
Plainfield, Illinois, 46168
Arcutis Biotherapeutics Clinical Site 25
Portland, Oregon, 97223
Arcutis Biotherapeutics Clinical Site 51
Rochester, New York, 14623
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 64
San Diego, California, 92123
Arcutis Biotherapeutics Clinical Site 65
Sanford, Florida, 32771
Arcutis Biotherapeutics Clinical Site 72
Santa Ana, California, 92701
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
Canada13 sites
Arcutis Biotherapeutics Clinical Site 38
Ajax, Ontario, L1S 7K8
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 09
Montreal, Quebec, H3Z 2S6
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, V3V0C6
Arcutis Biotherapeutics Clinical Site 71
Toronto, Ontario, M4W 2N2
Arcutis Biotherapeutics Clinical Site 36
Waterloo, Ontario, N2J 1C4
Arcutis Biotherapeutics Clinical Site 49
Windsor, Ontario, N8W 1E6
Arcutis Biotherapeutics Clinical Site 47
Winnepeg, Manitoba, R3M 3Z4
About this study
Official title: A Randomized tRial Employing topiCal roflumilasT Foam to Treat Scalp Psoriasis (ARRECTOR)
This was a parallel group, double blind, vehicle-controlled study to assess the safety and efficacy of roflumilast (ARQ-154) 0.3% foam vs vehicle foam applied once daily (qd) for 8 weeks by participants with plaque psoriasis of the scalp and body.
- Conditions
- Scalp Psoriasis
- Being tested
- Roflumilast Foam 0.3%, Vehicle Foam
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 0.3%
Roflumilast foam 0.3%
Vehicle FoamDrug
Vehicle foam matched to roflumilast 0.3% foam.
| Study group | Role | What they receive |
|---|---|---|
| Roflumilast Foam 0.3% | Active comparator | Participants with plaque psoriasis of the scalp and body applied roflumilast foam 0.3% once daily (qd) for 8 weeks. Receives: Drug: Roflumilast Foam 0.3% |
| Vehicle Foam | Placebo comparator | Participants with plaque psoriasis of the scalp and body applied 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 Scalp Investigator Global Assessment (S-IGA) "Success" at Week 8
The percentage of participants with S-IGA success at Week 8 is presented. Success is defined as an IGA score of 'clear' or 'almost clear' plus a 2-point improvement from baseline at Week 8. This global assessment scale has five severity grades reported from 0-4 and defined as Clear (0), Almost Clear (1), Mild (2), Moderate (3), Severe (4), with higher scores indicative of greater symptom severity.
Measured: Week 8
Achievement of Body Investigator Global Assessment (B-IGA) Success at Week 8
The percentage of participants with B-IGA success at Week 8 is presented. Success is defined as an IGA score of 'clear' or 'almost clear' plus a 2-point improvement from baseline at Week 8. This global assessment scale has five severity grades reported from 0-4 and defined as Clear (0), Almost Clear (1), Mild (2),Moderate (3), Severe (4), with higher scores indicative of greater symptom severity.
Measured: Week 8
Secondary outcomes (18)
Achievement of Scalp Itch-Numeric Rating Score (SI-NRS ) Success at Week 2
The percentage of participants with SI-NRS success at Week 2 is presented. Success is defined as a ≥ 4-point improvement from baseline weekly in weekly average SI-NRS in participants with weekly average baseline SI-NRS score ≥4. SI-NRS is a subject-reported severity of itch at its highest intensity during the previous 24-hour period. The scale ranges from 0 ("no itch") to 10 ("worst imaginable itch"), with higher scores indicative of greater symptom severity.
Measured: Week 2
Achievement of SI-NRS Success at Week 4
The percentage of participants with SI-NRS success at Week 4 is presented. Success is defined as a ≥ 4-point improvement from baseline weekly in weekly average SI-NRS in participants with weekly average baseline SI-NRS score ≥4. SI-NRS is a subject-reported severity of itch at its highest intensity during the previous 24-hour period. The scale ranges from 0 ("no itch") to 10 ("worst imaginable itch"), with higher scores indicative of greater symptom severity.
Measured: Week 4
Achievement of SI-NRS Success at Week 8
The percentage of participants with SI-NRS success at Week 8 is presented. Success is defined as a ≥ 4-point improvement from baseline weekly in weekly average SI-NRS in participants with weekly average baseline SI-NRS score ≥4. SI-NRS is a subject-reported severity of itch at its highest intensity during the previous 24-hour period. The scale ranges from 0 ("no itch") to 10 ("worst imaginable itch"), with higher scores indicative of greater symptom severity.
Measured: Week 8
Change From Baseline in SI-NRS Score at Day 1
SI-NRS is a subject-reported severity of itch at its highest intensity during the previous 24-hour period. The scale ranges from 0 ("no itch") to 10 ("worst imaginable itch"), with higher scores indicative of greater symptom severity. A negative change from baseline indicates symptom improvement, and vice versa.
Measured: Day 1
Change From Baseline in SI-NRS Score at Day 3
SI-NRS is a subject-reported severity of itch at its highest intensity during the previous 24-hour period. The scale ranges from 0 ("no itch") to 10 ("worst imaginable itch"), with higher scores indicative of greater symptom severity. A negative change from baseline indicates symptom improvement, and vice versa.
Measured: Day 3
Change From Baseline in SI-NRS Score at Week 1
SI-NRS is a subject-reported severity of itch at its highest intensity during the previous 24-hour period. The scale ranges from 0 ("no itch") to 10 ("worst imaginable itch"), with higher scores indicative of greater symptom severity. A negative change from baseline indicates symptom improvement, and vice versa.
Measured: Week 1
Achievement of WI-NRS (Worst Itch-Numeric Rating Score) Success at Week 8
WI-NRS is a subject-reported severity of itch at its highest intensity during the previous 24-hour period. The scale is from 0 ("no itch") to 10 ("worst imaginable itch"). Success is defined as achievement of a ≥ 4-point improvement from baseline in participants with a baseline WI-NRS pruritus score of ≥ 4.
Measured: Week 8
Achievement of a 75% Reduction From Baseline in Psoriasis Area and Severity Index (PASI-75)
The Psoriasis Area and Severity Index (PASI) is widely used for the measurement of severity of psoriasis. PASI combines the assessment of the severity of lesions and the area affected into a single score in the range from 0 (no disease) to 72 (maximal disease), with higher scores indicating greater symptom severity. A decrease from baseline indicates symptom improvement, and vice versa.
Measured: Week 8
Change From Baseline in Psoriasis Symptoms Diary (PSD) Aggregate Score of Itching, Pain, and Scaling (Questions 1, 9, and 11)
The PSD is a 16-item questionnaire asking subjects to rate the severity of psoriasis-related symptoms in the past 24 hours. Each question is scored from 0 ("no symptoms") to 10 ("worst imaginable symptoms"). Scores range from 0 to 160, with higher scores indicating greater symptom severity. The aggregate Itching, Pain, and Scaling score ranges from 0 to 30; the change from baseline in aggregate score was assessed per protocol only in adult participants.
Measured: Week 8
Percentage of Participants Achieving PSD Itching (Question 1) Score of 0 at Week 8
The PSD is a 16-item questionnaire asking subjects to rate the severity of psoriasis-related symptoms in the past 24 hours. Each question is scored from 0 ("no symptoms") to 10 ("worst imaginable symptoms"). Scores range from 0 to 160, with higher scores indicating greater symptom severity. The Scaling score ranges from 0 to 10.
Measured: Week 8
Percentage of Participants Achieving PSD Pain (Question 9) Score of 0 at Week 8
The PSD is a 16-item questionnaire asking subjects to rate the severity of psoriasis-related symptoms in the past 24 hours. Each question is scored from 0 ("no symptoms") to 10 ("worst imaginable symptoms"). Scores range from 0 to 160, with higher scores indicating greater symptom severity. The Pain score ranges from 0 to 10.
Measured: Week 8
Percentage of Participants Achieving PSD Scaling (Question 11) Score of 0 at Week 8
The PSD is a 16-item questionnaire asking subjects to rate the severity of psoriasis-related symptoms in the past 24 hours. Each question is scored from 0 ("no symptoms") to 10 ("worst imaginable symptoms"). Scores range from 0 to 160, with higher scores indicating greater symptom severity. The Scaling score ranges from 0 to 10.
Measured: Week 8
Percentage of Participants Achieving PSD Total Score of 0 at Week 8
Measured: Week 8
Achievement of a 75% Reduction From Baseline in Psoriasis Scalp Severity Index (PSSI) Score (PSSI-75)
The PSSI combines the assessment of the severity of scalp lesions and the area of scalp affected into a single score in the range 0 (no disease) to 72 (maximal disease). PSSI combines the assessment of the severity of scalp lesions and the area of scalp affected into a single score in the range 0 (no disease) to 72 (maximal disease).
Measured: Week 8
Achievement of S-IGA Score of 'Clear' at Week 8
The percentage of participants with S-IGA score of 0 Week 8 is presented. This global assessment scale has five severity grades reported from 0-4 and defined as Clear (0), Almost Clear (1), Mild (2), Moderate (3), Severe (4), with higher scores indicative of greater symptom severity.
Measured: Week 8
Achievement of S-IGA Success at Week 2
The percentage of participants with S-IGA success at Week 2 is presented. Success is defined as an IGA score of 'clear' or 'almost clear' plus a 2-point improvement from baseline. This global assessment scale has five severity grades reported from 0-4 and defined as Clear (0), Almost Clear (1), Mild (2), Moderate (3), Severe (4), with higher scores indicative of greater symptom severity.
Measured: Week 2
Achievement of S-IGA Success at Week 4
The percentage of participants with S-IGA success at Week 4 is presented. Success is defined as an IGA score of 'clear' or 'almost clear' plus a 2-point improvement from baseline. This global assessment scale has five severity grades reported from 0-4 and defined as Clear (0), Almost Clear (1), Mild (2), Moderate (3), Severe (4), with higher scores indicative of greater symptom severity.
Measured: Week 4
Change From Baseline in PASI Score at Week 2
The Psoriasis Area and Severity Index (PASI) is widely used for the measurement of severity of psoriasis. PASI combines the assessment of the severity of lesions and the area affected into a single score in the range from 0 (no disease) to 72 (maximal disease), with higher scores indicating greater symptom severity. A decrease from baseline indicates symptom improvement, and vice versa.
Measured: Week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2021
- Study start24 Aug 2021
- Primary completion3 Jun 2022
- Study completion3 Jun 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Scalp PsoriasisStudies 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
- 432 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
- NCT05028582
- Sponsor's protocol ID
- ARQ-154-309
- Acronym
- ARRECTOR
- Status last verified
- Jul 2025
- First submitted
- 25 Aug 2021
- Last updated
- 17 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gooderham MJ, Alonso-Llamazares J, Bagel J, Bhatia N, Bukhalo M, DuBois J, Ferris LK, Green L, Kircik LH, Lockshin B, Loo WJ, Papp KA, Soung J, Seal MS, Snyder S, Kato S, Krupa D, Burnett P, Berk DR, Chu DH. Roflumilast Foam, 0.3%, for Psoriasis of the Scalp and Body: The ARRECTOR Phase 3 Randomized Clinical Trial. JAMA Dermatol. 2025 Jul 1;161(7):698-706. doi: 10.1001/jamadermatol.2025.1136.
PubMed 40332898
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized tRial Employing topiCal roflumilasT Foam to Treat Scalp Psoriasis (ARRECTOR)
- ClinicalTrials.gov ID
- NCT05028582
- Acronym / sponsor ID
- ARRECTOR / ARQ-154-309
- Conditions
- Scalp Psoriasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 432 participants (actual)
- Lead sponsor
- Arcutis Biotherapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Aug 2021 (actual)
- Primary completion
- 3 Jun 2022 (actual)
- Study completion
- 3 Jun 2022 (actual)
- First posted
- 31 Aug 2021 (actual)
- Results
- Posted 17 Jul 2025
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 to assess the safety and efficacy of roflumilast (ARQ-154) 0.3% foam vs vehicle foam applied once daily (qd) for 8 weeks by participants with plaque psoriasis of the scalp and body.
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 with plaque psoriasis of the scalp and body applied roflumilast foam 0.3% once daily (qd) for 8 weeks. |
| Vehicle Foam | Placebo comparator | Drug: Vehicle FoamParticipants with plaque psoriasis of the scalp and body applied vehicle foam qd for 8 weeks. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- For adult subjects: Participants legally competent to read, write, and sign and give informed consent. For adolescent subjects: Informed consent of a parent(s) or legal guardian, and assent by the subjects, as required by local laws.
- Males and females ages 12 years and older (inclusive) at the time of consent or assent.
- Scalp psoriasis with a Scalp-Investigator Global Assessment of Disease (S IGA) severity of at least Moderate ('3') at Baseline.
- Extent of scalp psoriasis involving ≥ 10% of the total scalp at Baseline.
- A Psoriasis Scalp Severity Index (PSSI) of at least 6 at Baseline.
Key exclusion criteria (7 listed)
- Subjects who cannot discontinue treatment with therapies for the treatment of psoriasis vulgaris prior to the Baseline visit and during the study.
- Planned excessive exposure to treated area(s) to either natural or artificial sunlight, tanning bed, or other LED.
- Previous treatment with ARQ-151 or ARQ-154.
- 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.
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-154 0.3%Roflumilast foam 0.3% | Drug | Roflumilast Foam 0.3% |
| Vehicle FoamVehicle foam matched to roflumilast 0.3% foam. | Drug | Vehicle Foam |
Primary outcome
Achievement of Scalp Investigator Global Assessment (S-IGA) "Success" at Week 8
Time frame: Week 8
The percentage of participants with S-IGA success at Week 8 is presented. Success is defined as an IGA score of 'clear' or 'almost clear' plus a 2-point improvement from baseline at Week 8. This global assessment scale has five severity grades reported from 0-4 and defined as Clear (0), Almost Clear (1), Mild (2), Moderate (3), Severe (4), with higher scores indicative of greater symptom severity.
Achievement of Body Investigator Global Assessment (B-IGA) Success at Week 8
Time frame: Week 8
The percentage of participants with B-IGA success at Week 8 is presented. Success is defined as an IGA score of 'clear' or 'almost clear' plus a 2-point improvement from baseline at Week 8. This global assessment scale has five severity grades reported from 0-4 and defined as Clear (0), Almost Clear (1), Mild (2),Moderate (3), Severe (4), with higher scores indicative of greater symptom severity.
18 secondary outcomes
Achievement of Scalp Itch-Numeric Rating Score (SI-NRS ) Success at Week 2
Time frame: Week 2
Achievement of SI-NRS Success at Week 4
Time frame: Week 4
Achievement of SI-NRS Success at Week 8
Time frame: Week 8
Change From Baseline in SI-NRS Score at Day 1
Time frame: Day 1
Change From Baseline in SI-NRS Score at Day 3
Time frame: Day 3
Change From Baseline in SI-NRS Score at Week 1
Time frame: Week 1
Achievement of WI-NRS (Worst Itch-Numeric Rating Score) Success at Week 8
Time frame: Week 8
Achievement of a 75% Reduction From Baseline in Psoriasis Area and Severity Index (PASI-75)
Time frame: Week 8
Change From Baseline in Psoriasis Symptoms Diary (PSD) Aggregate Score of Itching, Pain, and Scaling (Questions 1, 9, and 11)
Time frame: Week 8
Percentage of Participants Achieving PSD Itching (Question 1) Score of 0 at Week 8
Time frame: Week 8
Percentage of Participants Achieving PSD Pain (Question 9) Score of 0 at Week 8
Time frame: Week 8
Percentage of Participants Achieving PSD Scaling (Question 11) Score of 0 at Week 8
Time frame: Week 8
Percentage of Participants Achieving PSD Total Score of 0 at Week 8
Time frame: Week 8
Achievement of a 75% Reduction From Baseline in Psoriasis Scalp Severity Index (PSSI) Score (PSSI-75)
Time frame: Week 8
Achievement of S-IGA Score of 'Clear' at Week 8
Time frame: Week 8
Achievement of S-IGA Success at Week 2
Time frame: Week 2
Achievement of S-IGA Success at Week 4
Time frame: Week 4
Change From Baseline in PASI Score at Week 2
Time frame: Week 2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40332898Gooderham MJ, Alonso-Llamazares J, Bagel J, Bhatia N, Bukhalo M, DuBois J, Ferris LK, Green L, Kircik LH, Lockshin B, Loo WJ, Papp KA, Soung J, Seal MS, Snyder S, Kato S, Krupa D, Burnett P, Berk DR, Chu DH. Roflumilast Foam, 0.3%, for Psoriasis of the Scalp and Body: The ARRECTOR Phase 3 Randomized Clinical Trial. JAMA Dermatol. 2025 Jul 1;161(7):698-706. doi: 10.1001/jamadermatol.2025.1136.
- 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.
49 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 0.3% in people with Scalp Psoriasis, run by Arcutis Biotherapeutics, Inc. at 49 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 12 inclusion and 7 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 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 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 17 Jul 2025). 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 Scalp Investigator Global Assessment (S-IGA) "Success" at Week 8 (time frame: Week 8). The study lists 2 primary outcomes in all. 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 NCT05028582, 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 17 Jul 2025.