| Primary | 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. | All treated participants in Cohort 1 are included. | Posted | | Count of Participants | | Participants | | Up to 3 weeks | | | | ID | Title | Description |
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| OG000 | Cohort 1: ARQ-252 Cream 0.3% QD | Participants applied ARQ-252 cream 0.3% QD to both hands for 2 weeks. | | OG001 | Cohort 2: ARQ-252 Cream 0.3% QD | Participants applied ARQ-252 cream 0.3% QD to both hands for 12 weeks. | | OG002 | Cohort 2: ARQ-252 Cream 0.3% BID | Participants applied ARQ-252 cream 0.3% BID to both hands for 12 weeks. | | OG003 | Cohort 2: ARQ-252 Cream 0.1% QD | Participants applied ARQ-252 cream 0.1% QD to both hands for 12 weeks. | | OG004 | Cohort 2: Vehicle Cream QD | Participants applied ARQ-252 Vehicle Cream QD to both hands for 12 weeks. | | OG005 | Cohort 2: Vehicle Cream BID | Participants applied ARQ-252 Vehicle Cream BID to both hands for 12 weeks. |
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| Primary | 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. | All treated participants in Cohort 1 are included. | Posted | | Count of Participants | | Participants | | Up to 3 weeks | | | | ID | Title | Description |
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| OG000 | Cohort 1: ARQ-252 Cream 0.3% QD | Participants applied ARQ-252 cream 0.3% QD to both hands for 2 weeks. | | OG001 | Cohort 2: ARQ-252 Cream 0.3% QD | Participants applied ARQ-252 cream 0.3% QD to both hands for 12 weeks. | | OG002 | Cohort 2: ARQ-252 Cream 0.3% BID | Participants applied ARQ-252 cream 0.3% BID to both hands for 12 weeks. | | OG003 | Cohort 2: ARQ-252 Cream 0.1% QD | Participants applied ARQ-252 cream 0.1% QD to both hands for 12 weeks. | | OG004 | Cohort 2: Vehicle Cream QD |
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| Primary | 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. | All treated participants in Cohort 1 are included. | Posted | | Count of Participants | | Participants | | Up to 3 weeks | | | | ID | Title | Description |
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| OG000 | Cohort 1: ARQ-252 Cream 0.3% QD | Participants applied ARQ-252 cream 0.3% QD to both hands for 2 weeks. | | OG001 | Cohort 2: ARQ-252 Cream 0.3% QD | Participants applied ARQ-252 cream 0.3% QD to both hands for 12 weeks. | | OG002 | Cohort 2: ARQ-252 Cream 0.3% BID | Participants applied ARQ-252 cream 0.3% BID to both hands for 12 weeks. | | OG003 | Cohort 2: ARQ-252 Cream 0.1% QD |
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| Primary | 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. | All treated participants in Cohort 1 are included. | Posted | | Count of Participants | | Participants | | Up to 3 weeks | | | | ID | Title | Description |
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| OG000 | Cohort 1: ARQ-252 Cream 0.3% QD | Participants applied ARQ-252 cream 0.3% QD to both hands for 2 weeks. | | OG001 | Cohort 2: ARQ-252 Cream 0.3% QD | Participants applied ARQ-252 cream 0.3% QD to both hands for 12 weeks. | | OG002 | Cohort 2: ARQ-252 Cream 0.3% BID | Participants applied ARQ-252 cream 0.3% BID to both hands for 12 weeks. | | OG003 | Cohort 2: ARQ-252 Cream 0.1% QD | Participants applied ARQ-252 cream 0.1% QD to both hands for 12 weeks. | | OG004 | Cohort 2: Vehicle Cream QD |
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| Primary | 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. | All treated participants in Cohort 1 are included. | Posted | | Count of Participants | | Participants | | Up to 3 weeks | | | | ID | Title | Description |
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| OG000 | Cohort 1: ARQ-252 Cream 0.3% QD | Participants applied ARQ-252 cream 0.3% QD to both hands for 2 weeks. | | OG001 | Cohort 2: ARQ-252 Cream 0.3% QD | Participants applied ARQ-252 cream 0.3% QD to both hands for 12 weeks. | | OG002 | Cohort 2: ARQ-252 Cream 0.3% BID | Participants applied ARQ-252 cream 0.3% BID to both hands for 12 weeks. | | OG003 | Cohort 2: ARQ-252 Cream 0.1% QD | Participants applied ARQ-252 cream 0.1% QD to both hands for 12 weeks. | | OG004 | Cohort 2: Vehicle Cream QD |
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| Primary | 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. | Participants from Cohort 2 with data available are included. Note that all Cohort 2 Vehicle Cream (QD or BID) participants are pooled for analysis. | Posted | | Count of Participants | | Participants | | Week 12 | | | | ID | Title | Description |
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| OG000 | Cohort 1: ARQ-252 Cream 0.3% QD | Participants applied ARQ-252 cream 0.3% QD to both hands for 2 weeks. | | OG001 | Cohort 2: ARQ-252 Cream 0.3% QD | Participants applied ARQ-252 cream 0.3% QD to both hands for 12 weeks. | | OG002 | Cohort 2: ARQ-252 Cream 0.3% BID | Participants applied ARQ-252 cream 0.3% BID to both hands for 12 weeks. | | OG003 | Cohort 2: ARQ-252 Cream 0.1% QD | |
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| Secondary | 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. | Participants from Cohort 2 with data available are included. Note that all Cohort 2 Vehicle Cream (QD or BID) participants are pooled for analysis. | Posted | | Count of Participants | | Participants | | Weeks 2, 4, 8 and 12 | | | | ID | Title | Description |
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| OG000 | Cohort 1: ARQ-252 Cream 0.3% QD | Participants applied ARQ-252 cream 0.3% QD to both hands for 2 weeks. | | OG001 | Cohort 2: ARQ-252 Cream 0.3% QD | Participants applied ARQ-252 cream 0.3% QD to both hands for 12 weeks. | | OG002 | Cohort 2: ARQ-252 Cream 0.3% BID | Participants applied ARQ-252 cream 0.3% BID to both hands for 12 weeks. | | OG003 | Cohort 2: ARQ-252 Cream 0.1% QD |
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| Secondary | 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. | Participants from Cohort 2 with data available are included. Note that all Cohort 2 Vehicle Cream (QD or BID) participants are pooled for analysis. | Posted | | Count of Participants | | Participants | | Weeks 2, 4, 8 and 12 | | | | ID | Title | Description |
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| OG000 | Cohort 1: ARQ-252 Cream 0.3% QD | Participants applied ARQ-252 cream 0.3% QD to both hands for 2 weeks. | | OG001 | Cohort 2: ARQ-252 Cream 0.3% QD | Participants applied ARQ-252 cream 0.3% QD to both hands for 12 weeks. | | OG002 | Cohort 2: ARQ-252 Cream 0.3% BID | Participants applied ARQ-252 cream 0.3% BID to both hands for 12 weeks. | | OG003 | Cohort 2: ARQ-252 Cream 0.1% QD | |
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| Secondary | 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. | Participants from Cohort 2 with data available are included. Note that all Cohort 2 Vehicle Cream (QD or BID) participants are pooled for analysis. | Posted | | Count of Participants | | Participants | | Weeks 2, 4, and 8 | | | | ID | Title | Description |
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| OG000 | Cohort 1: ARQ-252 Cream 0.3% QD | Participants applied ARQ-252 cream 0.3% QD to both hands for 2 weeks. | | OG001 | Cohort 2: ARQ-252 Cream 0.3% QD | Participants applied ARQ-252 cream 0.3% QD to both hands for 12 weeks. | | OG002 | Cohort 2: ARQ-252 Cream 0.3% BID | Participants applied ARQ-252 cream 0.3% BID to both hands for 12 weeks. | | OG003 | Cohort 2: ARQ-252 Cream 0.1% QD | Participants applied ARQ-252 cream 0.1% QD to both hands for 12 weeks. |
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| Secondary | 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. | All participants in Cohort 2 are included. | Posted | | Mean | Standard Deviation | units on a scale | | Weeks 2, 4, 8, and 12 | | | | ID | Title | Description |
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| OG000 | Cohort 1: ARQ-252 Cream 0.3% QD | Participants applied ARQ-252 cream 0.3% QD to both hands for 2 weeks. | | OG001 | Cohort 2: ARQ-252 Cream 0.3% QD | Participants applied ARQ-252 cream 0.3% QD to both hands for 12 weeks. | | OG002 | Cohort 2: ARQ-252 Cream 0.3% BID | Participants applied ARQ-252 cream 0.3% BID to both hands for 12 weeks. | | OG003 | Cohort 2: ARQ-252 Cream 0.1% QD | Participants applied ARQ-252 cream 0.1% QD to both hands for 12 weeks. |
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| Secondary | 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. | All participants in Cohort 2 with data available are included. | Posted | | Mean | Standard Error | score on a scale | | Weeks 2, 4, 8, and 12 | | | | ID | Title | Description |
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| OG000 | Cohort 1: ARQ-252 Cream 0.3% QD | Participants applied ARQ-252 cream 0.3% QD to both hands for 2 weeks. | | OG001 | Cohort 2: ARQ-252 Cream 0.3% QD | Participants applied ARQ-252 cream 0.3% QD to both hands for 12 weeks. | | OG002 | Cohort 2: ARQ-252 Cream 0.3% BID | Participants applied ARQ-252 cream 0.3% BID to both hands for 12 weeks. | | OG003 | Cohort 2: ARQ-252 Cream 0.1% QD | Participants applied ARQ-252 cream 0.1% QD to both hands for 12 weeks. |
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| Secondary | 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. | All randomized participants in Cohort 2 with data available and who had baseline WI-NRS scores ≥4 are included. | Posted | | Count of Participants | | Participants | | Weeks 2, 4, 8, and 12 | | | | ID | Title | Description |
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| OG000 | Cohort 1: ARQ-252 Cream 0.3% QD | Participants applied ARQ-252 cream 0.3% QD to both hands for 2 weeks. | | OG001 | Cohort 2: ARQ-252 Cream 0.3% QD | Participants applied ARQ-252 cream 0.3% QD to both hands for 12 weeks. | | OG002 | Cohort 2: ARQ-252 Cream 0.3% BID | Participants applied ARQ-252 cream 0.3% BID to both hands for 12 weeks. | | OG003 |
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| Secondary | 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. | All participants in Cohort 2 with data available are included. | Posted | | Mean | Standard Deviation | score on a scale | | Weeks 2, 4, 8, and 12 | | | | ID | Title | Description |
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| OG000 | Cohort 1: ARQ-252 Cream 0.3% QD | Participants applied ARQ-252 cream 0.3% QD to both hands for 2 weeks. | | OG001 | Cohort 2: ARQ-252 Cream 0.3% QD | Participants applied ARQ-252 cream 0.3% QD to both hands for 12 weeks. | | OG002 | Cohort 2: ARQ-252 Cream 0.3% BID | Participants applied ARQ-252 cream 0.3% BID to both hands for 12 weeks. | | OG003 |
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| Secondary | 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. | All participants in Cohort 2 with data available are included. | Posted | | Mean | Standard Deviation | score on a scale | | Weeks 2, 4, 8, and 12 | | | | ID | Title | Description |
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| OG000 | Cohort 1: ARQ-252 Cream 0.3% QD | Participants applied ARQ-252 cream 0.3% QD to both hands for 2 weeks. | | OG001 | Cohort 2: ARQ-252 Cream 0.3% QD | Participants applied ARQ-252 cream 0.3% QD to both hands for 12 weeks. | | OG002 | Cohort 2: ARQ-252 Cream 0.3% BID | Participants applied ARQ-252 cream 0.3% BID to both hands for 12 weeks. | | OG003 | Cohort 2: ARQ-252 Cream 0.1% QD | Participants applied ARQ-252 cream 0.1% QD to both hands for 12 weeks. |
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| Secondary | 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. | All participants in Cohort 2 who had baseline NRS Pain scores ≥4 and with data available are included. | Posted | | Count of Participants | | Participants | | Weeks 2, 4, 8, and 12 | | | | ID | Title | Description |
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| OG000 | Cohort 1: ARQ-252 Cream 0.3% QD | Participants applied ARQ-252 cream 0.3% QD to both hands for 2 weeks. | | OG001 | Cohort 2: ARQ-252 Cream 0.3% QD | Participants applied ARQ-252 cream 0.3% QD to both hands for 12 weeks. | | OG002 | Cohort 2: ARQ-252 Cream 0.3% BID | Participants applied ARQ-252 cream 0.3% BID to both hands for 12 weeks. | | OG003 | Cohort 2: ARQ-252 Cream 0.1% QD | |
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| Secondary | 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'). | All participants in Cohort 2 with data available are included. | Posted | | Mean | Standard Error | score on a scale | | Weeks 2, 4, 8, 12, 13 | | | | ID | Title | Description |
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| OG000 | Cohort 1: ARQ-252 Cream 0.3% QD | Participants applied ARQ-252 cream 0.3% QD to both hands for 2 weeks. | | OG001 | Cohort 2: ARQ-252 Cream 0.3% QD | Participants applied ARQ-252 cream 0.3% QD to both hands for 12 weeks. | | OG002 | Cohort 2: ARQ-252 Cream 0.3% BID | Participants applied ARQ-252 cream 0.3% BID to both hands for 12 weeks. | |
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| Secondary | 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). | All participants in Cohort 2 with data available are included. | Posted | | Mean | Standard Error | Percentage of Total BSA | | Weeks 2, 4, 8, 12 | | | | ID | Title | Description |
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| OG000 | Cohort 1: ARQ-252 Cream 0.3% QD | Participants applied ARQ-252 cream 0.3% QD to both hands for 2 weeks. | | OG001 | Cohort 2: ARQ-252 Cream 0.3% QD | Participants applied ARQ-252 cream 0.3% QD to both hands for 12 weeks. | | OG002 | Cohort 2: ARQ-252 Cream 0.3% BID | Participants applied ARQ-252 cream 0.3% BID to both hands for 12 weeks. |
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