Chronic Hand EczemaPhase 1/2NCT04378569
Safety and Efficacy of ARQ-252 Cream in Subjects With Chronic Hand Eczema
A Phase 1/2 study testing ARQ-252 cream 0.3% and ARQ-252 cream 0.1% in people with Chronic Hand Eczema, run by Arcutis Biotherapeutics, Inc. at 37 sites in 3 countries.
Trial summary
This study will assess the safety and efficacy of ARQ-252 cream in subjects with chronic hand eczema Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hand Eczema
- What is being tested?
- ARQ-252 cream 0.3% and ARQ-252 cream 0.1%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 230 participants
- Where
- 37 sitesin 3 countries
- Study dates
- 20 Apr 2020to 24 Feb 2021
- Phase
- Phase 1/2
- 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 18 years of age and older (inclusive) at the time of consent.
- Clinical diagnosis of chronic hand eczema, defined as hand eczema persistent for more than 3 months, or returned twice or more within the last 12 months. Generally stable disease for 6 weeks.
- Chronic hand eczema involving at least 0.3% body surface area total (i.e., approximately a third of one handprint) lesions on both hands added together
- Female subjects of childbearing potential (FOCBP) must have a negative serum pregnancy test at Screening and negative urine pregnancy test at Baseline. For FOCBP involved in any sexual intercourse that could lead to pregnancy: the subject must agree to use a highly effective contraceptive method for at least 4 weeks prior to Day 1. Additionally, from Day 1 until at least 4 weeks after the last investigational product administration, these subjects must agree to use at least 1 highly effective contraceptive method in addition to 1 barrier method according to the Contraception Requirements Section of the protocol.
- Females of non-childbearing potential must either be post-menopausal with spontaneous amenorrhea for at least 12 months or have undergone surgical sterilization.
- Males, if engaging in sexual intercourse with a female who is pregnant or a female of childbearing potential, must agree to use a condom every time during the study and every and every time subsequently until 4 weeks after the last dose of investigational product.
- Subjects in good health as judged by the Investigator, based on medical history, physical examination, 12-lead electrocardiogram (ECG), serum chemistry labs, hematology values, and urinalysis.
Who cannot join
- Concurrent skin diseases on the hands which, in the opinion of the Investigator, could confound the study (e.g., tinnea manuum).
- Subjects with any presence or history of psoriasis.
- History of a positive patch test with continued exposure to allergen. Subjects must have undergone diagnostic patch testing within 3 years prior to Baseline (Visit 2).
- Subjects who cannot discontinue systemic and/or topical therapies for the treatment of chronic hand eczema prior to Baseline and during the study
- Subjects with a history of chronic alcohol or drug abuse within 6 months prior to Baseline
- Pregnant or lactating women or women planning to become pregnant during the study and / or within 28 days following the last dose of investigational product.
- Subjects with any serious medical condition or clinically significant laboratory, ECG, vital signs or physical examination abnormality that would prevent study participation or place the subject at significant risk, as judged by the Investigator.
Trial locations and contacts
37 sites in 3 countries.
37 sites in 3 countries
United States25 sites
Arcutis Clinical Site 162
Austin, Texas, 78759
Arcutis Clinical Site 174
Aventura, Florida, 33180
Arcutis Clinical Site 239
Beverly Hills, California, 90212
Arcutis Clinical Site 104
College Station, Texas, 77845
Arcutis Clinical Site 167
Coral Gables, Florida, 33134
Arcutis Clinical Site 212
Detroit, Michigan, 48202
Arcutis Clinical Site 225
Encino, California, 91436
Arcutis Clinical Site 112
Fremont, California, 94538
Arcutis Clinical Site 115
High Point, North Carolina, 27262
Arcutis Clinical Site 164
Houston, Texas, 77056
Arcutis Clinical Site 214
Indianapolis, Indiana, 46250
Arcutis Clinical Site 120
Irvine, California, 92797
Arcutis Clinical Site 217
Louisville, Kentucky, 40217
Arcutis Clinical Site 213
Metairie, Louisiana, 70006
Arcutis Clinical Site 216
New Brighton, Minnesota, 55112
Arcutis Clinical Site 171
New York, New York, 10029
Arcutis Clinical Site 169
Norfolk, Virginia, 23502
Arcutis Clinical Site 163
Pflugerville, Texas, 78660
Arcutis Clinical Site 135
Pittsburgh, Pennsylvania, 15213
Arcutis Clinical Site 173
Portland, Oregon, 97210
Arcutis Clinical Site 125
Rockville, Maryland, 20850
Arcutis Clinical Site 161
San Antonio, Texas, 78213
Arcutis Clinical Site 110
San Antonio, Texas, 78218
Arcutis Clinical Site 104
Sanford, Florida, 32771
Arcutis Clinical Site 208
Santa Monica, California, 90404
Canada10 sites
Arcutis Clinical Site 205
Ajax, Ontario
Arcutis Clinical Site 218
Barrie, Ontario
Arcutis Clinical Site 103
London, Ontario
Arcutis Clinical Site 133
Mississauga, Ontario
Arcutis Clinical Site 242
Montreal
Arcutis Clinical Site 165
Oakville, Ontario
Arcutis Clinical Site 109
Peterborough, Ontario
Arcutis Clinical Site 241
Richmond Hill, Ontario
Arcutis Clinical Site 207
Surrey, British Columbia
Arcutis Clinical Site 106
Waterloo, Ontario
Australia2 sites
Arcutis Clinical Site 303
East Melbourne, Victoria, 3002
Arcutis Clinical Site 306
Westmead, New South Wales, 2145
About this study
Official title: A Phase 1/2b, Multiple Dose and 12-Week, Parallel Group, Double Blind, Dose Ranging, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-252 Cream 0.1% and ARQ-252 Cream 0.3% in Subjects With Chronic Hand Eczema
This study will assess the safety and efficacy of ARQ-252 cream in subjects with chronic hand eczema
Read the detailed description
This is a Phase 1/2b multiple dose, parallel group, double blind, vehicle-controlled study of the safety and efficacy of ARQ-252 cream in subjects with chronic hand eczema
- Conditions
- Chronic Hand Eczema
- Being tested
- ARQ-252 cream 0.3%, ARQ-252 cream 0.1%, ARQ-252 Vehicle Cream
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARQ-252 cream 0.3%Drug
ARQ-252 cream 0.3%
ARQ-252 cream 0.1%Drug
ARQ-252 cream 0.1%
ARQ-252 Vehicle CreamDrug
ARQ-252 Vehicle Cream
| Study group | Role | What they receive |
|---|---|---|
| ARQ-252 cream 0.3% QD (once daily) | Active comparator | Active Comparator Receives: Drug: ARQ-252 cream 0.3% |
| ARQ-252 cream 0.3% BID (twice daily) | Active comparator | Active Comparator Receives: Drug: ARQ-252 cream 0.3% |
| ARQ-252 cream 0.1% QD (once daily) | Active comparator | Active Comparator Receives: Drug: ARQ-252 cream 0.1% |
| Vehicle cream BID (twice daily) | Placebo comparator | Placebo Comparator Receives: Drug: ARQ-252 Vehicle Cream |
| Vehicle cream QD (once daily) | Placebo comparator | Placebo Comparator Receives: Drug: ARQ-252 Vehicle Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cohort 1: Number of Participants With ≥1 Adverse Event (AE)
The number of Cohort 1 participants with an AE 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.
Measured: Up to 3 weeks
Cohort 1: Number of Participants With an Application Site Reaction
The number of Cohort 1 participants with AEs coded as application site events is reported.
Measured: Up to 3 weeks
Cohort 1: Number of Participants With ≥1 Serious Adverse Event (SAE)
The number of Cohort 1 participants with an SAE 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.
Measured: Up to 3 weeks
Cohort 1: Number of Participants With Significant Changes in Hematology Laboratory Parameters
The number of Cohort 1 participants with a significant change in hematology is reported.
Measured: Up to 3 weeks
Cohort 1: Number of Participants With Significant Changes in Chemistry Laboratory Parameters
The number of Cohort 1 participants with a significant change in chemistry is reported.
Measured: Up to 3 weeks
Cohort 2: Investigator's Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' at Week 12
The IGA is 5-point scale assessing the severity of hand eczema; scores range from 0 ('completely clear') to 4 ('severe'), with higher scores indicating greater severity. The number of participants with an IGA score of 'clear' or 'almost clear' at Week 12 is presented.
Measured: Week 12
Secondary outcomes (11)
Cohort 2: Achievement of IGA Score of 'Clear' or 'Almost Clear' PLUS at Least a 2-point Improvement From Baseline
The IGA is 5-point scale assessing the severity of hand eczema, with scores ranging from 0 ('completely clear') to 4 ('severe'), with higher scores indicating greater severity. The number of participants with an IGA score of 'clear' or 'almost clear' plus ≥2-point improvement (ie, decrease) from Baseline is presented.
Measured: Weeks 2, 4, 8 and 12
Cohort 2: Achievement of at Least a 2-point Improvement in IGA Score From Baseline
The IGA is 5-point scale assessing the severity of hand eczema, with scores ranging from 0 ('completely clear') to 4 ('severe'), with higher scores indicating greater severity. The number of participants with ≥2-point improvement from baseline in IGA score is presented.
Measured: Weeks 2, 4, 8 and 12
Cohort 2: Achievement of IGA Score of 'Clear' or 'Almost Clear'
The IGA is 5-point scale assessing the severity of hand eczema, with scores ranging from 0 ('completely clear') to 4 ('severe'), with higher scores indicating greater severity. The number of participants with ≥2-point improvement from baseline is presented.
Measured: Weeks 2, 4, and 8
Cohort 2: Change From Baseline in Investigator's Global Assessment (IGA) Score
The IGA is 5-point scale assessing the severity of hand eczema, with scores ranging from 0 ('completely clear') to 4 ('severe'), with higher scores indicating greater severity. The mean change from baseline in IGA score is presented, with lower scores indicating a reduction in symptom severity.
Measured: Weeks 2, 4, 8, and 12
Cohort 2: Change From Baseline in Worst Itch Numeric Rating Scale (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. The mean change from baseline in WI-NRS is reported.
Measured: Weeks 2, 4, 8, and 12
Cohort 2: Achievement of ≥4-point Reduction From Baseline in Worst Itch Numeric Rating Scale (WI-NRS) Pruritus 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 (higher scores indicate higher itch severity). The mean change from baseline in WI-NRS is reported. The number of participants with a baseline WI-NRS score of ≥4 who achieved a ≥4-point reduction is reported.
Measured: Weeks 2, 4, 8, and 12
Cohort 2: Change From Baseline in Hand Eczema Severity Index (HECSI) Score
The HECSI is an instrument used in clinical trials to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) on 5 areas of the hand (fingertips, fingers [except tips], palm, back of hand, wrists) by use of a standard scale. Each subscale is scored from 0 to 60; the total HECSI score ranges from 0 to 360 with higher scores indicating greater symptom severity. The mean change from baseline in HECSI is reported.
Measured: Weeks 2, 4, 8, and 12
Cohort 2: Change From Baseline in Numerical Rating Scale (NRS) for Pain Score
The NRS Pain Scale is a widely-used instrument for pain screening. Participants rate the intensity of pain experienced in the past 24 hours on a scale from 0 ('no pain at all') to 10 ('worst pain possible'). The mean change from baseline NRS Pain score is reported.
Measured: Weeks 2, 4, 8, and 12
Cohort 2: The Rate of Achievement of ≥4-point Reduction From Baseline in Pain Numerical Rating Scale (NRS) Score
The NRS Pain Scale is a widely-used instrument for pain screening. Participants rate the intensity of pain experienced in the past 24 hours on a scale from 0 ('no pain at all') to 10 ('worst pain possible'). The number of participants with ≥4-point reduction from baseline NRS Pain score is reported.
Measured: Weeks 2, 4, 8, and 12
Cohort 2: Change From Baseline in Overall Quality of Life in Hand Eczema Questionnaire (QOLHEQ) Score at Each Visit
The QOLHEQ is an instrument to assess disease specific Health Related Quality of Life (HRQOL) in patients suffering from hand eczema. The QOLHEQ is a disease specific instrument, thereby only assessing impairments caused by hand eczema. It consists of 30 items which can be summarized according to four domains of HRQOL: Impairments because of (1) symptoms, (2) emotions, (3) limitations in functioning or (4) because of treatment and prevention. The scoring ranges from 0 ('no eczema') to 117 ('most severe eczema').
Measured: Weeks 2, 4, 8, 12, 13
Cohort 2: Change From Baseline in Total Body Surface Area (BSA) Affected by Disease
The percentage of total body surface area (BSA) affected by chronic hand eczema (CHE) is a measure of the area of the subject's hands that is affected by CHE lesions, expressed as a percentage of total BSA. Based on the subject's hand method, the BSA of 1 side of 1 hand is assumed to be 1% of total BSA. The surface area of lesions on both sides of both hands are added to calculate the total BSA affected by CHE. The total BSA affected by CHE ranges from 0% (no CHE lesions) to 4% (the entire front and back sides of both hands are affected by CHE lesions).
Measured: Weeks 2, 4, 8, 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2020
- Study start20 Apr 2020
- Primary completion24 Feb 2021
- Study completion24 Feb 2021
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 Hand EczemaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There are 2 cohorts of subjects. * Cohort 1 (Phase 1) is a multiple dose cohort in which subjects with chronic hand eczema will be assigned to ARQ-252 cream 0.3% QD x 2 weeks to be applied to both hands (approximately 4% of BSA). * Cohort 2 (Phase 2b) is a parallel group, double blind, vehicle-controlled cohort in which subjects with chronic hand eczema will be randomized to ARQ-252 cream 0.3% QD, ARQ-252 cream 0.3% BID, ARQ-252 cream 0.1% QD, vehicle cream BID or vehicle cream QD x 12 weeks to be applied to both hands (approximately 4% of BSA).
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 230 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
- NCT04378569
- Sponsor's protocol ID
- ARQ-252-205
- Status last verified
- Apr 2024
- First submitted
- 30 Apr 2020
- Last updated
- 5 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2b, Multiple Dose and 12-Week, Parallel Group, Double Blind, Dose Ranging, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-252 Cream 0.1% and ARQ-252 Cream 0.3% in Subjects With Chronic Hand Eczema
- ClinicalTrials.gov ID
- NCT04378569
- Acronym / sponsor ID
- ARQ-252-205
- Conditions
- Chronic Hand Eczema
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Arcutis Biotherapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Apr 2020 (actual)
- Primary completion
- 24 Feb 2021 (actual)
- Study completion
- 24 Feb 2021 (actual)
- First posted
- 7 May 2020 (actual)
- Results
- Posted 5 Apr 2024
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-252 cream in subjects with chronic hand eczema
Detailed description
This is a Phase 1/2b multiple dose, parallel group, double blind, vehicle-controlled study of the safety and efficacy of ARQ-252 cream in subjects with chronic hand eczema
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
- Model description
- There are 2 cohorts of subjects. * Cohort 1 (Phase 1) is a multiple dose cohort in which subjects with chronic hand eczema will be assigned to ARQ-252 cream 0.3% QD x 2 weeks to be applied to both hands (approximately 4% of BSA). * Cohort 2 (Phase 2b) is a parallel group, double blind, vehicle-controlled cohort in which subjects with chronic hand eczema will be randomized to ARQ-252 cream 0.3% QD, ARQ-252 cream 0.3% BID, ARQ-252 cream 0.1% QD, vehicle cream BID or vehicle cream QD x 12 weeks to be applied to both hands (approximately 4% of BSA).
| Arm | Type | Receives |
|---|---|---|
| ARQ-252 cream 0.3% QD (once daily) | Active comparator | Drug: ARQ-252 cream 0.3%Active Comparator |
| ARQ-252 cream 0.3% BID (twice daily) | Active comparator | Drug: ARQ-252 cream 0.3%Active Comparator |
| ARQ-252 cream 0.1% QD (once daily) | Active comparator | Drug: ARQ-252 cream 0.1%Active Comparator |
| Vehicle cream BID (twice daily) | Placebo comparator | Drug: ARQ-252 Vehicle CreamPlacebo Comparator |
| Vehicle cream QD (once daily) | Placebo comparator | Drug: ARQ-252 Vehicle CreamPlacebo Comparator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Participants legally competent to sign and give informed consent.
- Males and females 18 years of age and older (inclusive) at the time of consent.
- Clinical diagnosis of chronic hand eczema, defined as hand eczema persistent for more than 3 months, or returned twice or more within the last 12 months. Generally stable disease for 6 weeks.
- Chronic hand eczema involving at least 0.3% body surface area total (i.e., approximately a third of one handprint) lesions on both hands added together
- Female subjects of childbearing potential (FOCBP) must have a negative serum pregnancy test at Screening and negative urine pregnancy test at Baseline. For FOCBP involved in any sexual intercourse that could lead to pregnancy: the subject must agree to use a highly effective contraceptive method for at least 4 weeks prior to Day 1. Additionally, from Day 1 until at least 4 weeks after the last investigational product administration, these subjects must agree to use at least 1 highly effective contraceptive method in addition to 1 barrier method according to the Contraception Requirements Section of the protocol.
Key exclusion criteria (7 listed)
- Concurrent skin diseases on the hands which, in the opinion of the Investigator, could confound the study (e.g., tinnea manuum).
- Subjects with any presence or history of psoriasis.
- History of a positive patch test with continued exposure to allergen. Subjects must have undergone diagnostic patch testing within 3 years prior to Baseline (Visit 2).
- Subjects who cannot discontinue systemic and/or topical therapies for the treatment of chronic hand eczema prior to Baseline and during the study
- Subjects with a history of chronic alcohol or drug abuse within 6 months prior to Baseline
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 |
|---|---|---|
| ARQ-252 cream 0.3%ARQ-252 cream 0.3% | Drug | ARQ-252 cream 0.3% BID (twice daily), ARQ-252 cream 0.3% QD (once daily) |
| ARQ-252 cream 0.1%ARQ-252 cream 0.1% | Drug | ARQ-252 cream 0.1% QD (once daily) |
| ARQ-252 Vehicle CreamARQ-252 Vehicle Cream | Drug | Vehicle cream BID (twice daily), Vehicle cream QD (once daily) |
Primary outcome
Cohort 1: Number of Participants With ≥1 Adverse Event (AE)
Time frame: Up to 3 weeks
The number of Cohort 1 participants with an AE 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.
Cohort 1: Number of Participants With an Application Site Reaction
Time frame: Up to 3 weeks
The number of Cohort 1 participants with AEs coded as application site events is reported.
Cohort 1: Number of Participants With ≥1 Serious Adverse Event (SAE)
Time frame: Up to 3 weeks
The number of Cohort 1 participants with an SAE 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.
Cohort 1: Number of Participants With Significant Changes in Hematology Laboratory Parameters
Time frame: Up to 3 weeks
The number of Cohort 1 participants with a significant change in hematology is reported.
Cohort 1: Number of Participants With Significant Changes in Chemistry Laboratory Parameters
Time frame: Up to 3 weeks
The number of Cohort 1 participants with a significant change in chemistry is reported.
Cohort 2: Investigator's Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' at Week 12
Time frame: Week 12
The IGA is 5-point scale assessing the severity of hand eczema; scores range from 0 ('completely clear') to 4 ('severe'), with higher scores indicating greater severity. The number of participants with an IGA score of 'clear' or 'almost clear' at Week 12 is presented.
11 secondary outcomes
Cohort 2: Achievement of IGA Score of 'Clear' or 'Almost Clear' PLUS at Least a 2-point Improvement From Baseline
Time frame: Weeks 2, 4, 8 and 12
Cohort 2: Achievement of at Least a 2-point Improvement in IGA Score From Baseline
Time frame: Weeks 2, 4, 8 and 12
Cohort 2: Achievement of IGA Score of 'Clear' or 'Almost Clear'
Time frame: Weeks 2, 4, and 8
Cohort 2: Change From Baseline in Investigator's Global Assessment (IGA) Score
Time frame: Weeks 2, 4, 8, and 12
Cohort 2: Change From Baseline in Worst Itch Numeric Rating Scale (WI-NRS) Score
Time frame: Weeks 2, 4, 8, and 12
Cohort 2: Achievement of ≥4-point Reduction From Baseline in Worst Itch Numeric Rating Scale (WI-NRS) Pruritus Score
Time frame: Weeks 2, 4, 8, and 12
Cohort 2: Change From Baseline in Hand Eczema Severity Index (HECSI) Score
Time frame: Weeks 2, 4, 8, and 12
Cohort 2: Change From Baseline in Numerical Rating Scale (NRS) for Pain Score
Time frame: Weeks 2, 4, 8, and 12
Cohort 2: The Rate of Achievement of ≥4-point Reduction From Baseline in Pain Numerical Rating Scale (NRS) Score
Time frame: Weeks 2, 4, 8, and 12
Cohort 2: Change From Baseline in Overall Quality of Life in Hand Eczema Questionnaire (QOLHEQ) Score at Each Visit
Time frame: Weeks 2, 4, 8, 12, 13
Cohort 2: Change From Baseline in Total Body Surface Area (BSA) Affected by Disease
Time frame: Weeks 2, 4, 8, 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
37 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ARQ-252 cream 0.3% and ARQ-252 cream 0.1% in people with Chronic Hand Eczema, run by Arcutis Biotherapeutics, Inc. at 37 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 8 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 5 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in United States, Canada, Australia. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 5 Apr 2024). 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?
Cohort 1: Number of Participants With ≥1 Adverse Event (AE) (time frame: Up to 3 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Apr 2024.