Chronic Plaque PsoriasisPhase 3DERMIS-OLENCT04286607

Open-Label Extension Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis

A Phase 3 study testing Topical roflumilast in people with Chronic Plaque Psoriasis, run by Arcutis Biotherapeutics, Inc. at 85 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This study will assess the safety and efficacy of ARQ-151 cream applied once a day for 24 weeks by subjects with chronic plaque psoriasis Read more about this study

Who is it for?: Ages 2 to 11 years
Conditions the study is for: Chronic Plaque Psoriasis
What is being tested?: Topical roflumilast
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 337 participants
Where: 85 sitesin 3 countries
Study dates: 12 Feb 2020to 22 Jan 2024
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 2 to 11 years
All sexes
No healthy volunteers
Child

Who may be able to join

Participants legally competent to sign and give informed consent or informed consent of legal guardian, and, if age appropriate, assent by the subject, as required by local laws
Males and females ages 2 years and older (inclusive)
Subjects with chronic plaque psoriasis who meet eligibility criteria and:
Successfully completed a prior ARQ-151 cream study in psoriasis (Cohort 1) or
Are naïve to treatment with ARQ-151 cream (Cohort 2)
Females of childbearing potential (FOCBP) must have a negative pregnancy test at all study visits. In addition, sexually active FOCBP must agree to use at least one form of highly effective contraception throughout the trial.

Who cannot join

Subjects who experienced an ARQ-151 treatment-related AE or a serious AE (SAE) that precluded further treatment with ARQ-151 cream in a prior ARQ-151 cream study.
Planned excessive exposure of treated area(s) to either natural or artificial sunlight, tanning bed or other LED.
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 drug abuse within 6 months of initiation of investigational product.
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.

Trial locations and contacts

85 sites in 3 countries.

Country

City, postcode or hospital

85 sites in 3 countries

United States68 sites

Arcutis Biotherapeutics Clinical Site 206
Arlington, Texas, 76011
Arcutis Biotherapeutics Clinical Site 111
Baton Rouge, Louisiana, 70809
Arcutis Biotherapeutics Clinical Site 239
Beverly Hills, California, 90212
Arcutis Clinical Site 602
Boise, Idaho, 83706
Arcutis Biotherapeutics Clinical Site 223
Boynton Beach, Florida, 91436
Arcutis Biotherapeutics Clinical Site 101
Brighton, Massachusetts, 02135
Arcutis Biotherapeutics Clinical Site 229
Broomall, Pennsylvania, 19008
Arcutis Biotherapeutics Clinical Site 116
Clinton Township, Michigan, 48038
Arcutis Biotherapeutics Clinical Site 104
College Station, Texas, 77845
Arcutis Biotherapeutics Clinical Site 119
Dallas, Texas, 75246
Arcutis Biotherapeutics Clinical Site 237
DeLand, Florida, 32720
Arcutis Biotherapeutics Clinical Site 118
Delray Beach, Florida, 33484
Arcutis Biotherapeutics Clinical Site 212
Detroit, Michigan, 48202
Arcutis Biotherapeutics Clinical Site 128
Duncansville, Pennsylvania, 16635
Arcutis Biotherapeutics Clinical Site 129
East Windsor, New Jersey, 08520
Arcutis Biotherapeutics Clinical Site 127
Encinitas, California, 92024
Arcutis Biotherapeutics Clinical Site 225
Encino, California, 91436
Arcutis Biotherapeutics Clinical Site 113
Exton, Pennsylvania, 19003
Arcutis Biotherapeutics Clinical Site 124
Fairborn, Ohio, 45324
Arcutis Biotherapeutics Clinical Site 509
Fountain Valley, California, 92708
Arcutis Biotherapeutics Clinical Site 112
Fremont, California, 94538
Arcutis Biotherapeutics Clinical Site 216
Fridley, Minnesota, 55432
Arcutis Biotherapeutics Clinical Site 519
Frisco, Texas, 75034
Arcutis Biotherapeutics Clinical Site 202
Hialeah, Florida, 33016
Arcutis Biotherapeutics Clinical Site 115
High Point, North Carolina, 27262
Arcutis Biotherapeutics Clinical Site 238
Houston, Texas, 77030
Arcutis Biotherapeutics Clinical Site 214
Indianapolis, Indiana, 46250
Arcutis Biotherapeutics Clinical Site 120
Irvine, California, 92697
Arcutis Biotherapeutics Clinical Site 233
Knoxville, Tennessee, 37922
Arcutis Biotherapeutics Clinical Site 211
Lake Charles, Louisiana, 70605
Arcutis Biotherapeutics Clinical Site 228
Largo, Florida, 33770
Arcutis Biotherapeutics Clinical Site 219
Las Vegas, Nevada, 89148
Arcutis Biotherapeutics Clinical Site 231
Las Vegas, Nevada, 89148
Arcutis Biotherapeutics Clinical Site 508
Los Angeles, California, 90057
Arcutis Biotherapeutics Clinical Site 217
Louisville, Kentucky, 40217
Arcutis Biotherapeutics Clinical Site 213
Metairie, Louisiana, 70006
Arcutis Biotherapeutics Clinical Site 131
Miami, Florida, 33174
Arcutis Biotherapeutics Clinical Site 221
Murfreesboro, Tennessee, 37130
Arcutis Biotherapeutics Clinical Site 224
New Orleans, Louisiana, 70115
Arcutis Biotherapeutics Clinical Site 121
New York, New York, 10029
Arcutis Biotherapeutics Clinical Site 201
North Miami Beach, Florida, 33162
Arcutis Biotherapeutics Clinical Site 137
Ocala, Florida, 34470
Arcutis Biotherapeutics Clinical Site 222
Oklahoma City, Oklahoma, 73112
Arcutis Biotherapeutics Clinical Site 134
Oklahoma City, Oklahoma, 73118
Arcutis Biotherapeutics Clinical Site 135
Pittsburgh, Pennsylvania, 15213
Arcutis Biotherapeutics Clinical Site 114
Plainfield, Illinois, 46168
Arcutis Biotherapeutics Clinical Site 236
Portsmouth, New Hampshire, 03801
Arcutis Biotherapeutics Clinical Site 511
Rancho Santa Margarita, California, 92688
Arcutis Biotherapeutics Clinical Site 139
Reno, Nevada, 89509
Arcutis Biotherapeutics Clinical Site 240
Reno, Nevada, 89703
Arcutis Biotherapeutics Clinical Site 230
Richmond, Virginia, 23220
Arcutis Biotherapeutics Clinical Site 130
Rochester, New York, 14623
Arcutis Biotherapeutics Clinical Site 125
Rockville, Maryland, 20850
Arcutis Biotherapeutics Clinical Site 138
Rockville, Maryland, 20850
Arcutis Biotherapeutics Clinical Site 102
Rolling Meadows, Illinois, 60008
Arcutis Biotherapeutics Clinical Site 227
Saint Joseph, Missouri, 64506
Arcutis Biotherapeutics Clinical Site 110
San Antonio, Texas, 78218
Arcutis Biotherapeutics Clinical Site 117
San Antonio, Texas, 78229
Arcutis Biotherapeutics Clinical Site 123
San Diego, California, 92123
Arcutis Biotherapeutics Clinical Site 220
San Diego, California, 92123
Arcutis Biotherapeutics Clinical Site 136
San Francisco, California, 94132
Arcutis Biotherapeutics Clinical Site 105
Sanford, Florida, 32771
Arcutis Biotherapeutics Clinical Site 208
Santa Monica, California, 90404
Arcutis Biotherapeutics Clinical Site 215
Santa Monica, California, 90503
Arcutis Biotherapeutics Clinical Site 203
Scottsdale, Arizona, 85255
Arcutis Biotherapeutics Clinical Site 108
Stony Brook, New York, 11790
Arcutis Biotherapeutics Clinical Site 209
Sweetwater, Florida, 33172
Arcutis Biotherapeutics Clinical Site 210
West Jordan, Utah, 84088

Other trials in United States

Canada16 sites

Arcutis Biotherapeutics Clinical Site 205
Ajax, Ontario, L1S 7K8
Arcutis Biotherapeutics Clinical Site 218
Barrie, Ontario, L4M 7G1
Arcutis Biotherapeutics Clinical Site 132
Calgary, Alberta, T1Y 0B4
Arcutis Biotherapeutics Clinical Site 234
Fredericton, New Brunswick, E3B 1G9
Arcutis Biotherapeutics Clinical Site 103
London, Ontario, N6H 5L5
Arcutis Biotherapeutics Clinical Site 133
Mississauga, Ontario, L5H 1G9
Arcutis Biotherapeutics Clinical Site 107
Montreal, Quebec, H3Z 2S6
Arcutis Biotherapeutics Clinical Site 140
Ottawa, Ontario, K2C 3N2
Arcutis Biotherapeutics Clinical Site 109
Peterborough, Ontario, K9J 5K2
Arcutis Biotherapeutics Clinical Site 126
Québec, Quebec, G1V4X7
Arcutis Biotherapeutics Clinical Site 207
Surrey, British Columbia, V3R 6A7
Arcutis Biotherapeutics Clinical Site 226
Surrey, British Columbia, V3V0C6
Arcutis Biotherapeutics Clinical Site 235
Toronto, Ontario, M4W 2N2
Arcutis Biotherapeutics Clinical Site 106
Waterloo, Ontario, N2J 1C4
Arcutis Biotherapeutics Clinical Site 204
Windsor, Ontario, N8W 1E6
Arcutis Biotherapeutics Clinical Site 232
Winnepeg, Manitoba, R3M 3Z4

Other trials in Canada

Dominican Republic1 site

Arcutis Clinical Site 601
Santo Domingo

Other trials in Dominican Republic

About this study

Official title: A Phase 3, Multicenter, Open-Label Extension Study of the Long-Term Safety of ARQ-151 Cream 0.3% in Subjects With Chronic Plaque Psoriasis

This study will assess the safety and efficacy of ARQ-151 cream applied once a day for 24 weeks by subjects with chronic plaque psoriasis

Read the detailed description

This is an open-label study in which ARQ-151 cream is applied once daily x 24 weeks to subjects with psoriasis

Conditions: Chronic Plaque Psoriasis
Being tested: Topical roflumilast

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Topical roflumilastDrug
Also called ARQ-151 Cream 0.3%
Active treatment

Study groups in NCT04286607
Study group	Role	What they receive
ARQ-151 Cream 0.3%	Experimental	Not described Receives: Drug: Topical roflumilast

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With ≥1 Treatment-Emergent Adverse Events (TEAEs)
The percentage of participants with ≥TEAE is reported.
Measured: Up to 24 weeks
Percentage of Participants With ≥1 Serious Adverse Events (SAEs)
The percentage of participants with ≥1 SAE is reported.
Measured: Up to 24 weeks

Secondary outcomes (8)

Achievement of an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' Over Time
The percentage of participants achieving an IGA score of 0 or 1 is reported. The IGA is a 5-point scale assessing the severity of skin issues, with scores ranging from 0 ('clear') to 4 ('severe'), and higher scores indicate greater symptom severity.
Measured: Weeks 4, 12, and 24
Duration of Response (DOR) for Participants Achieving an IGA Score of 'Clear' or 'Almost Clear'
The Kaplan-Meier (KM) median DOR (days) of IGA score of clear or almost clear is reported. The IGA is a 5-point scale assessing the severity of skin issues, with scores ranging from 0 ('clear') to 4 ('severe'), and higher scores indicate greater symptom severity. The duration of response starts with the first assessment of clear or almost clear, which could be as early as the Week 2 assessment in the feeder study, and continues until the participant's disease worsens or completes their involvement in the study. Therefore, the time variable could be as long as 30 weeks, 6 weeks in the feeder study plus 24 weeks in the ARQ-151-306 study.
Measured: Up to Week 30
Return to IGA Score of ≥2 After Achieving an IGA Score of 'Clear' or 'Almost Clear'
The percentage of participants worsening to IGA Score of ≥2 after achieving an IGA score of clear or almost clear is reported. The IGA is a 5-point scale assessing the severity of skin issues, with scores ranging from 0 ('clear') to 4 ('severe'), and higher scores indicate greater symptom severity.
Measured: Up to Week 24
Achievement of a 50% Reduction in Psoriasis Area Severity Index (PASI-50) Score Over Time
The percentage of participants achieving PASI-50 is reported. The 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.
Measured: Weeks 4, 12, and 24
Achievement of a 75% Reduction in Psoriasis Area Severity Index (PASI-75) Score Over Time
The percentage of participants achieving PASI-75 is reported. The 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.
Measured: Weeks 4, 12, and 24
Achievement of a 90% Reduction in Psoriasis Area Severity Index (PASI-90) Score Over Time
The percentage of participants achieving PASI-90 is reported. The 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.
Measured: Weeks 4, 12, and 24
Achievement of a 100% Reduction in Psoriasis Area Severity Index (PASI-100) Score Over Time
The percentage of participants achieving PASI-100 is reported. The 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.
Measured: Weeks 4, 12, and 24
Achievement of Success in Worst Itch Numeric Rating Scale (WI-NRS) Score Over Time
The percentage of participants achieving WI-NRS success is reported. WI-NRS "success" is defined as a ≥4 point improvement from a baseline score of ≥4. 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 participant experienced in the past 24 hours. Higher scores indicate greater symptom severity.
Measured: Weeks 4, 12, and 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Feb 202022 Jan 2024

First posted27 Feb 2020
Study start12 Feb 2020
Primary completion22 Jan 2024
Study completion22 Jan 2024

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 Chronic Plaque 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 337 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04286607
Sponsor's protocol ID: ARQ-151-306
Acronym: DERMIS-OLE
Status last verified: Jul 2026
First submitted: 25 Feb 2020
Last updated: 9 Sep 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 3
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Guselkumab for the Treatment of Chronic Plaque Psoriasis in Pediatric Participants
Psoriasis
RecruitingObservational study
Collection of Samples From Subjects With Various Skin Conditions and Healthy Volunteers
Acne, Atopic Dermatitis
RecruitingPhase 4
An Open Label Trial to Evaluate Efficacy and Safety of Roflumilast 0.3% Cream for Chronic Plaque and Nail Psoriasis
Chronic Plaque Psoriasis, Nail Psoriasis
RecruitingPhase 2
Early Intervention in Plaque Psoriasis: is Bimekizumab Able to Delay Chronic Inflammation?
Psoriasis
RecruitingObservational study
Serum Substance P, Neuropathic Pain, and Central Sensitization Across Treatment Groups in Chronic Plaque Psoriasis
Chronic Plaque-type Psoriasis

All Chronic Plaque Psoriasis trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Multicenter, Open-Label Extension Study of the Long-Term Safety of ARQ-151 Cream 0.3% in Subjects With Chronic Plaque Psoriasis
ClinicalTrials.gov ID: NCT04286607
Acronym / sponsor ID: DERMIS-OLE / ARQ-151-306
Conditions: Chronic Plaque Psoriasis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 337 participants (actual)
Lead sponsor: Arcutis Biotherapeutics, Inc.Industry (pharma, biotech, devices)
Study start: 12 Feb 2020 (actual)
Primary completion: 22 Jan 2024 (actual)
Study completion: 22 Jan 2024 (actual)
First posted: 27 Feb 2020 (actual)
Results: Posted 9 Sep 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study will assess the safety and efficacy of ARQ-151 cream applied once a day for 24 weeks by subjects with chronic plaque psoriasis

Detailed description

This is an open-label study in which ARQ-151 cream is applied once daily x 24 weeks to subjects with psoriasis

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
ARQ-151 Cream 0.3%	Experimental	Drug: Topical roflumilast

Who may qualify

Ages: 2 to 11 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (6 listed)

Participants legally competent to sign and give informed consent or informed consent of legal guardian, and, if age appropriate, assent by the subject, as required by local laws
Males and females ages 2 years and older (inclusive)
Subjects with chronic plaque psoriasis who meet eligibility criteria and:
Females of childbearing potential (FOCBP) must have a negative pregnancy test at all study visits. In addition, sexually active FOCBP must agree to use at least one form of highly effective contraception throughout the trial.

Key exclusion criteria (6 listed)

Subjects who experienced an ARQ-151 treatment-related AE or a serious AE (SAE) that precluded further treatment with ARQ-151 cream in a prior ARQ-151 cream study.
Planned excessive exposure of treated area(s) to either natural or artificial sunlight, tanning bed or other LED.
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 drug abuse within 6 months of initiation of investigational product.

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
Topical roflumilastAlso: ARQ-151 Cream 0.3%Active treatment	Drug	ARQ-151 Cream 0.3%

Primary outcome

Percentage of Participants With ≥1 Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to 24 weeks
The percentage of participants with ≥TEAE is reported.
Percentage of Participants With ≥1 Serious Adverse Events (SAEs)
Time frame: Up to 24 weeks
The percentage of participants with ≥1 SAE is reported.

8 secondary outcomes

Achievement of an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' Over Time
Time frame: Weeks 4, 12, and 24
Duration of Response (DOR) for Participants Achieving an IGA Score of 'Clear' or 'Almost Clear'
Time frame: Up to Week 30
Return to IGA Score of ≥2 After Achieving an IGA Score of 'Clear' or 'Almost Clear'
Time frame: Up to Week 24
Achievement of a 50% Reduction in Psoriasis Area Severity Index (PASI-50) Score Over Time
Time frame: Weeks 4, 12, and 24
Achievement of a 75% Reduction in Psoriasis Area Severity Index (PASI-75) Score Over Time
Time frame: Weeks 4, 12, and 24
Achievement of a 90% Reduction in Psoriasis Area Severity Index (PASI-90) Score Over Time
Time frame: Weeks 4, 12, and 24
Achievement of a 100% Reduction in Psoriasis Area Severity Index (PASI-100) Score Over Time
Time frame: Weeks 4, 12, and 24
Achievement of Success in Worst Itch Numeric Rating Scale (WI-NRS) Score Over Time
Time frame: Weeks 4, 12, and 24

Results and safety

Results posted to the registry on 9 Sep 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1 Group 1: Prior Roflumilast Cream 0.3%	264	232
Cohort 1 Group 2: Prior Roflumilast Cream 0.3%	9	6
Cohort 2: No Prior Roflumilast Cream	60	56

Primary outcome: Percentage of Participants With ≥1 Treatment-Emergent Adverse Events (TEAEs)

Time frame: Up to 24 weeks. Number. Unit: percentage of participants

Measure	Cohort 1 Group 1: Prior Roflumilast Cream 0.3% n = 264	Cohort 1 Group 2: Prior Roflumilast Cream 0.3% n = 9	Cohort 2: No Prior Roflumilast Cream n = 60
Value	26.1	33.3	56.7

Population analysed: All treated participants are included.

Primary outcome: Percentage of Participants With ≥1 Serious Adverse Events (SAEs)

Time frame: Up to 24 weeks. Number. Unit: percentage of participants

Measure	Cohort 1 Group 1: Prior Roflumilast Cream 0.3% n = 264	Cohort 1 Group 2: Prior Roflumilast Cream 0.3% n = 9	Cohort 2: No Prior Roflumilast Cream n = 60
Value	1.1	0	1.7

Population analysed: All treated participants are included.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to ~24 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1 Group 1: Prior Roflumilast Cream 0.3%	3 of 264 (1.1%)	10 of 264 (3.8%)	0 of 264
Cohort 1 Group 2: Prior Roflumilast Cream 0.3%	0 of 9 (0%)	3 of 9 (33.3%)	0 of 9
Cohort 2: No Prior Roflumilast Cream	1 of 60 (1.7%)	26 of 60 (43.3%)	0 of 60

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Chronic Plaque Psoriasis

Active, not recruitingPhase 3
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Guselkumab for the Treatment of Chronic Plaque Psoriasis in Pediatric Participants
Psoriasis
RecruitingObservational study
Collection of Samples From Subjects With Various Skin Conditions and Healthy Volunteers
Acne, Atopic Dermatitis
RecruitingPhase 4
An Open Label Trial to Evaluate Efficacy and Safety of Roflumilast 0.3% Cream for Chronic Plaque and Nail Psoriasis
Chronic Plaque Psoriasis, Nail Psoriasis
RecruitingPhase 2
Early Intervention in Plaque Psoriasis: is Bimekizumab Able to Delay Chronic Inflammation?
Psoriasis
RecruitingObservational study
Serum Substance P, Neuropathic Pain, and Central Sensitization Across Treatment Groups in Chronic Plaque Psoriasis
Chronic Plaque-type Psoriasis

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.

85 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Topical roflumilast in people with Chronic Plaque Psoriasis, run by Arcutis Biotherapeutics, Inc. at 85 sites in 3 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 6 inclusion and 6 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 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 85 sites in United States, Canada, Dominican Republic. 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. 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 9 Sep 2026). 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?

Percentage of Participants With ≥1 Treatment-Emergent Adverse Events (TEAEs) (time frame: Up to 24 weeks). 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 NCT04286607.

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 9 Sep 2026.