Trial · NCT04445987
Long-Term Safety of ARQ-154 Foam in Subjects With Seborrheic Dermatitis
NCT04445987, Phase 2, Completed, Arcutis Biotherapeutics, Inc.; results first posted 2024-06-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Long-Term Safety of ARQ-154 Foam in Subjects With Seborrheic Dermatitis. Trials, record NCT04445987. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04445987
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Long-Term Safety of ARQ-154 Foam in Subjects With Seborrheic Dermatitis
- NCT number
- NCT04445987
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 408 participants, actual
- Lead sponsor
- Arcutis Biotherapeutics, Inc.
- Conditions
- Seborrheic Dermatitis
- Interventions
- ARQ-154
- First posted
- 2020-06-24
- Last updated
- 2024-06-11
- Results first posted
- 2024-06-11
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With ≥1 Adverse Event (AE) | Up to 52 weeks | The number of participants with treatment-emergent AEs is reported. An AE is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to participation in the research. Data are presented according to cohort group assigned as treatment were identical in this study regardless of the treatment received in the prior study. |
| Primary | Number of Participants With ≥1 Serious Adverse Event (SAE) | Up to 52 weeks | The number of participants with treatment-emergent SAEs is reported. An SAE is any AE that results in death, is life-threatening (places the subject at immediate risk of death from the event as it occurred), requires inpatient hospitalization or prolongation of existing hospitalization, results in a persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, or is any other adverse event that, based upon appropriate medical judgment, may jeopardize the subject's health. Data are presented according to cohort group assigned as treatment were identical in this study regardless of the treatment received in the prior study. |
| Secondary | Number of Participants With an Investigator Global Assessment (IGA) Score of Completely Clear or Almost Clear | Weeks 4, 12, 24, 36, and 52 | The number of participants with an IGA score of 0 ('completely clear') or 1 ('almost clear') is presented. The IGA is a 5-point scale assessing the severity of seborrheic dermatitis, with scores ranging from 0 ('clear') to 4 ('severe'), and higher scores indicate greater symptom severity. |
| Secondary | Achievement of IGA Success | Weeks 4, 12, 24, 36, and 52 | The number of participants achieving "success" in IGA assessment of disease severity is presented. Success was defined as achievement of an IGA score of 0 ('clear') or 1 ('almost clear') at Week 8, accompanied by a ≥2-grade improvement from baseline IGA score. The IGA is a 5-point scale assessing the severity of seborrheic dermatitis, with scores ranging from 0 ('clear') to 4 ('severe'), and higher scores indicate greater symptom severity. |
| Secondary | Duration of IGA Success | Weeks 4, 12, 24, 36, and 52 | The duration of "success" in IGA assessment of disease severity is presented. Success was defined as achievement of an IGA score of 0 ('clear') or 1 ('almost clear') at Week 8, accompanied by a ≥2-grade improvement from baseline IGA score. The IGA is a 5-point scale assessing the severity of seborrheic dermatitis, with scores ranging from 0 ('clear') to 4 ('severe'), and higher scores indicate greater symptom severity. The time from first observation of IGA success to the first subsequent time a participant's disease response did not meet the criteria for IGA success is presented. The duration of IGA success for subjects who ended treatment in IGA success was censored at the last disease assessment date. |
| Secondary | IGA Treatment-Free Interval | Weeks 4, 12, 24, 36, and 52 | The treatment-free interval is defined as time from when the participant achieves disease clearance (IGA score of 0 \["completely clear"\]) and stops treatment of all lesions until the time of restarting treatment. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With ≥1 Adverse Event (AE) | Up to 52 weeks | All participants are included. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With ≥1 Serious Adverse Event (SAE) | Up to 52 weeks | All participants are included. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With an Investigator Global Assessment (IGA) Score of Completely Clear or Almost Clear | Weeks 4, 12, 24, 36, and 52 | All treated participants with data available and who had baseline IGA score \>1 are included. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Achievement of IGA Success | Weeks 4, 12, 24, 36, and 52 | All treated participants with data available and who had baseline IGA score ≥2 are included. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of IGA Success | Weeks 4, 12, 24, 36, and 52 | All treated participants who achieved IGA success and had data available are included. | weeks | MEDIAN |
| SECONDARY | IGA Treatment-Free Interval | Weeks 4, 12, 24, 36, and 52 | All treated participants who achieved an IGA score of 0 are included. | weeks | MEDIAN |
Source ClinicalTrials.gov
Results by group74
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With ≥1 Adverse Event (AE) | Cohort 1 Group 1: ARQ-154-203 Roflumilast Foam 0.3% Without Treatment Gap | 17 | Participants | ||
| Number of Participants With ≥1 Adverse Event (AE) | Cohort 2 Groups 3 and 4: ARQ-154-203 Roflumilast Foam 0.3% With Treatment Gap | 23 | Participants | ||
| Number of Participants With ≥1 Adverse Event (AE) | Cohort 2 Group 4: De Novo Participants | 90 | Participants | ||
| Number of Participants With ≥1 Adverse Event (AE) | Cohort 1 Group 2: ARQ-154-116 Rollover | 3 | Participants | ||
| Number of Participants With ≥1 Serious Adverse Event (SAE) | Cohort 1 Group 1: ARQ-154-203 Roflumilast Foam 0.3% Without Treatment Gap | 2 | Participants | ||
| Number of Participants With ≥1 Serious Adverse Event (SAE) | Cohort 2 Group 3: ARQ-154-203 Roflumilast Foam 0.3% With Treatment Gap | 0 | Participants | ||
| Number of Participants With ≥1 Serious Adverse Event (SAE) | Cohort 2 Group 4: De Novo Participants | 5 | Participants | ||
| Number of Participants With ≥1 Serious Adverse Event (SAE) | Cohort 1 Group 2: ARQ-154-116 Rollover | 0 | Participants | ||
| Number of Participants With an Investigator Global Assessment (IGA) Score of Completely Clear or Almost Clear | Cohort 1 Group 1: ARQ-154-203 Roflumilast Foam 0.3% Without Treatment Gap | Week 4 | 36 | Participants | |
| Number of Participants With an Investigator Global Assessment (IGA) Score of Completely Clear or Almost Clear | Cohort 1 Group 1: ARQ 154-203 Vehicle Foam Rolled Over Without Treatment Gap | Week 4 | 7 | Participants |
1 to 10 of 74Source ClinicalTrials.gov
See all 74 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1 Group 1: ARQ-154-203 Roflumilast Foam 0.3% Without Treatment Gap | 52 | |
| Overall Study | STARTED | Cohort 1 Group 1: ARQ 154-203 Vehicle Foam Rolled Over Without Treatment Gap | 23 | |
| Overall Study | STARTED | Cohort 2 Group 3: ARQ-154-203 Roflumilast Foam 0.3% With Treatment Gap | 41 | |
| Overall Study | STARTED | Cohort 2 Group 3: ARQ-154-203 Vehicle Foam With Treatment Gap | 17 | |
| Overall Study | STARTED | Cohort 2 Group 4: De Novo Participants | 267 | |
| Overall Study | STARTED | Cohort 1 Group 2: ARQ-154-116 Rollover | 8 | |
| Overall Study | COMPLETED | Cohort 1 Group 1: ARQ-154-203 Roflumilast Foam 0.3% Without Treatment Gap | 43 | |
| Overall Study | COMPLETED | Cohort 1 Group 1: ARQ 154-203 Vehicle Foam Rolled Over Without Treatment Gap | 20 | |
| Overall Study | COMPLETED | Cohort 2 Group 3: ARQ-154-203 Roflumilast Foam 0.3% With Treatment Gap | 37 | |
| Overall Study | COMPLETED | Cohort 2 Group 3: ARQ-154-203 Vehicle Foam With Treatment Gap | 16 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events60
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | COVID-19 | Infections and infestations | Cohort 1 Group 1: ARQ-154-203 Roflumilast Foam 0.3% Without Treatment Gap | 3 | 75 | |
| other | COVID-19 | Infections and infestations | Cohort 2 Group 3: ARQ-154-203 Roflumilast Foam 0.3% Without Treatment Gap | 3 | 58 | |
| other | COVID-19 | Infections and infestations | Cohort 2 Group 4: De Novo Participants | 9 | 267 | |
| other | COVID-19 | Infections and infestations | Cohort 1 Group 2: ARQ-154-116 Rollover | 0 | 8 | |
| other | Urinary tract infection | Infections and infestations | Cohort 1 Group 1: ARQ-154-203 Roflumilast Foam 0.3% Without Treatment Gap | 0 | 75 | |
| other | Urinary tract infection | Infections and infestations | Cohort 2 Group 3: ARQ-154-203 Roflumilast Foam 0.3% Without Treatment Gap | 4 | 58 | |
| other | Urinary tract infection | Infections and infestations | Cohort 2 Group 4: De Novo Participants | 3 | 267 | |
| other | Urinary tract infection | Infections and infestations | Cohort 1 Group 2: ARQ-154-116 Rollover | 0 | 8 | |
| other | Weight decreased | Investigations | Cohort 1 Group 1: ARQ-154-203 Roflumilast Foam 0.3% Without Treatment Gap | 0 | 75 | |
| other | Weight decreased | Investigations | Cohort 2 Group 3: ARQ-154-203 Roflumilast Foam 0.3% Without Treatment Gap | 0 | 58 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1 Group 1: ARQ-154-203 Roflumilast Foam 0.3% Without Treatment Gap | 0 | 75 |
| Total, all-cause mortality | Cohort 2 Group 3: ARQ-154-203 Roflumilast Foam 0.3% Without Treatment Gap | 0 | 58 |
| Total, all-cause mortality | Cohort 2 Group 4: De Novo Participants | 1 | 267 |
| Total, all-cause mortality | Cohort 1 Group 2: ARQ-154-116 Rollover | 0 | 8 |
| Total, other adverse events | Cohort 1 Group 1: ARQ-154-203 Roflumilast Foam 0.3% Without Treatment Gap | 3 | 75 |
| Total, other adverse events | Cohort 2 Group 3: ARQ-154-203 Roflumilast Foam 0.3% Without Treatment Gap | 4 | 58 |
| Total, other adverse events | Cohort 2 Group 4: De Novo Participants | 11 | 267 |
| Total, other adverse events | Cohort 1 Group 2: ARQ-154-116 Rollover | 6 | 8 |
| Total, serious adverse events | Cohort 1 Group 1: ARQ-154-203 Roflumilast Foam 0.3% Without Treatment Gap | 2 | 75 |
| Total, serious adverse events | Cohort 2 Group 3: ARQ-154-203 Roflumilast Foam 0.3% Without Treatment Gap | 0 | 58 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41175336 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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