Trial · NCT04655313
Maximal Usage Pharmacokinetics and Safety of ARQ-151 in Children With Plaque Psoriasis (ARQ-151-215)
NCT04655313, Phase 2, Completed, Arcutis Biotherapeutics, Inc.; results first posted 2023-12-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Maximal Usage Pharmacokinetics and Safety of ARQ-151 in Children With Plaque Psoriasis (ARQ-151-215). Trials, record NCT04655313. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04655313
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Maximal Usage Pharmacokinetics and Safety of ARQ-151 in Children With Plaque Psoriasis (ARQ-151-215)
- NCT number
- NCT04655313
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 20 participants, actual
- Lead sponsor
- Arcutis Biotherapeutics, Inc.
- Conditions
- Psoriasis, Plaque Psoriasis
- Interventions
- ARQ-151 cream 0.3%
- First posted
- 2020-12-07
- Last updated
- 2023-12-15
- Results first posted
- 2023-12-15
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Plasma Concentration of ARQ-151 Cream 0.3% | Predose on Days 14 and 28 | Plasma levels of circulating roflumilast were determined at 2 points in the study. |
| Primary | Plasma Concentration of the Roflumilast Major N-oxide Metabolite | Predose on Days 14 and 28 | Plasma levels of circulating the roflumilast major N-oxide metabolite were determined at 2 points in the study. |
| Primary | Number of Participants With ≥1 Adverse Event (AE) | Up to 28 days | The number of participants with adverse events during the treatment period is reported. An AE is any untoward or unfavorable medical occurrence in a 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 the participant's participation in the research. |
| Primary | Number of Participants With Application Site Reactions | Baseline (Day 1), Day 7, and Day 14 | The number of subjects experiencing an application site skin reactions by investigator assessment is reported. The investigator assessed for erythema prior to that day's application of investigational product. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Plasma Concentration of ARQ-151 Cream 0.3% | Predose on Days 14 and 28 | Participants with data available are included. | ng/mL | MEAN |
| PRIMARY | Plasma Concentration of the Roflumilast Major N-oxide Metabolite | Predose on Days 14 and 28 | Participants with data available are included. | ng/mL | MEAN |
| PRIMARY | Number of Participants With ≥1 Adverse Event (AE) | Up to 28 days | All treated participants are included. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Application Site Reactions | Baseline (Day 1), Day 7, and Day 14 | All treated participants are included. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Plasma Concentration of ARQ-151 Cream 0.3% | ARQ-151 Cream 0.3% | Day 14 | 3.15 | Standard Deviation 3.64 | ng/mL |
| Plasma Concentration of ARQ-151 Cream 0.3% | ARQ-151 Cream 0.3% | Day 28 | 1.68 | Standard Deviation 1.57 | ng/mL |
| Plasma Concentration of the Roflumilast Major N-oxide Metabolite | ARQ-151 Cream 0.3% | Day 14 | 28.9 | Standard Deviation 41.1 | ng/mL |
| Plasma Concentration of the Roflumilast Major N-oxide Metabolite | ARQ-151 Cream 0.3% | Day 28 | 15.7 | Standard Deviation 15.8 | ng/mL |
| Number of Participants With ≥1 Adverse Event (AE) | ARQ-151 Cream 0.3% | 4 | Participants | ||
| Number of Participants With Application Site Reactions | ARQ-151 Cream 0.3% | Day 1: No erythema | 18 | Participants | |
| Number of Participants With Application Site Reactions | ARQ-151 Cream 0.3% | Day 1: Minimal erythema | 0 | Participants | |
| Number of Participants With Application Site Reactions | ARQ-151 Cream 0.3% | Day 1: Definite erythema | 1 | Participants | |
| Number of Participants With Application Site Reactions | ARQ-151 Cream 0.3% | Day 7: No erythema | 17 | Participants | |
| Number of Participants With Application Site Reactions | ARQ-151 Cream 0.3% | Day 7: Minimal erythema | 3 | Participants |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | ARQ-151 Cream 0.3% | 20 | |
| Overall Study | COMPLETED | ARQ-151 Cream 0.3% | 20 | |
| Overall Study | NOT COMPLETED | ARQ-151 Cream 0.3% | 0 |
Source ClinicalTrials.gov
Adverse events8
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 | Candida infection | Infections and infestations | ARQ-151 Cream 0.3% | 1 | 20 | |
| other | Application site pain | Injury, poisoning and procedural complications | ARQ-151 Cream 0.3% | 1 | 20 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | ARQ-151 Cream 0.3% | 1 | 20 | |
| other | Headache | Nervous system disorders | ARQ-151 Cream 0.3% | 1 | 20 | |
| other | Perineal pain | Reproductive system and breast disorders | ARQ-151 Cream 0.3% | 1 | 20 | |
| other | Nasal congestion | Respiratory, thoracic and mediastinal disorders | ARQ-151 Cream 0.3% | 1 | 20 | |
| other | Dermatitis | Skin and subcutaneous tissue disorders | ARQ-151 Cream 0.3% | 1 | 20 | |
| other | Perineal erythema | Skin and subcutaneous tissue disorders | ARQ-151 Cream 0.3% | 1 | 20 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ARQ-151 Cream 0.3% | 0 | 20 |
| Total, other adverse events | ARQ-151 Cream 0.3% | 4 | 20 |
| Total, serious adverse events | ARQ-151 Cream 0.3% | 0 | 20 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40862624 | 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
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04655313
GET https://conductscience.org/api/trials/v1/NCT04655313/registered