Chronic Hand Eczema
Conditions
Brief summary
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
Interventions
ARQ-252 cream 0.3%
DRUGARQ-252 cream 0.1%
ARQ-252 cream 0.1%
ARQ-252 Vehicle Cream
Sponsors
Arcutis Biotherapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention 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).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cohort 1: Number of Participants With ≥1 Adverse Event (AE) | 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 | 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) | 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 | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cohort 2: Change From Baseline in Hand Eczema Severity Index (HECSI) Score | Weeks 2, 4, 8, and 12 | 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. |
| Cohort 2: Change From Baseline in Numerical Rating Scale (NRS) for Pain Score | Weeks 2, 4, 8, and 12 | 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. |
| Cohort 2: Achievement of IGA Score of 'Clear' or 'Almost Clear' PLUS at Least a 2-point Improvement From Baseline | Weeks 2, 4, 8 and 12 | 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. |
| Cohort 2: Change From Baseline in Overall Quality of Life in Hand Eczema Questionnaire (QOLHEQ) Score at Each Visit | Weeks 2, 4, 8, 12, 13 | 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'). |
| Cohort 2: Change From Baseline in Total Body Surface Area (BSA) Affected by Disease | Weeks 2, 4, 8, 12 | 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). |
| Cohort 2: The Rate of Achievement of ≥4-point Reduction From Baseline in Pain Numerical Rating Scale (NRS) Score | Weeks 2, 4, 8, and 12 | 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. |
| Cohort 2: Achievement of at Least a 2-point Improvement in IGA Score From Baseline | Weeks 2, 4, 8 and 12 | 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. |
| Cohort 2: Achievement of IGA Score of 'Clear' or 'Almost Clear' | Weeks 2, 4, and 8 | 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. |
| Cohort 2: Change From Baseline in Investigator's Global Assessment (IGA) Score | Weeks 2, 4, 8, and 12 | 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. |
| Cohort 2: Change From Baseline in Worst Itch Numeric Rating Scale (WI-NRS) Score | Weeks 2, 4, 8, and 12 | 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. |
| Cohort 2: Achievement of ≥4-point Reduction From Baseline in Worst Itch Numeric Rating Scale (WI-NRS) Pruritus Score | Weeks 2, 4, 8, and 12 | 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. |
Countries
Australia, Canada, United States
Participant flow
Recruitment details
This study was conducted at 36 centers in the United States, Canada, and Australia.
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1: ARQ-252 Cream 0.3% QD Participants applied ARQ-252 cream 0.3% QD to both hands for 2 weeks. | 7 |
| Cohort 2: ARQ-252 Cream 0.3% QD Participants applied ARQ-252 cream 0.3% QD to both hands for 12 weeks. | 65 |
| Cohort 2: ARQ-252 Cream 0.3% BID Participants applied ARQ-252 cream 0.3% BID to both hands for 12 weeks. | 61 |
| Cohort 2: ARQ-252 Cream 0.1% QD Participants applied ARQ-252 cream 0.1% QD to both hands for 12 weeks. | 32 |
| Cohort 2: Vehicle Cream QD Participants applied ARQ-252 Vehicle Cream QD to both hands for 12 weeks. | 33 |
| Cohort 2: Vehicle Cream BID Participants applied ARQ-252 Vehicle Cream BID to both hands for 12 weeks. | 32 |
| Total | 230 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 2 | 0 | 3 | 3 |
| Overall Study | Lack of response | 0 | 0 | 1 | 0 | 1 | 1 |
| Overall Study | Lost to Follow-up | 0 | 3 | 1 | 0 | 1 | 1 |
| Overall Study | Protocol Violation | 0 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 6 | 7 | 4 | 5 | 4 |
Baseline characteristics
| Characteristic | Cohort 2: Vehicle Cream BID | Total | Cohort 1: ARQ-252 Cream 0.3% QD | Cohort 2: ARQ-252 Cream 0.3% QD | Cohort 2: ARQ-252 Cream 0.3% BID | Cohort 2: ARQ-252 Cream 0.1% QD | Cohort 2: Vehicle Cream QD |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 43.3 years STANDARD_DEVIATION 13.36 | 42.2 years STANDARD_DEVIATION 14.24 | 45.4 years STANDARD_DEVIATION 9.18 | 41.6 years STANDARD_DEVIATION 15.08 | 43.3 years STANDARD_DEVIATION 15.05 | 41.6 years STANDARD_DEVIATION 15.33 | 40.3 years STANDARD_DEVIATION 12.06 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 44 Participants | 3 Participants | 11 Participants | 12 Participants | 5 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 27 Participants | 186 Participants | 4 Participants | 54 Participants | 49 Participants | 27 Participants | 25 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Hand Eczema Severity Index (HECSI) Mean Baseline Score | 38.9 score on a scale STANDARD_DEVIATION 32.72 | 42.9 score on a scale STANDARD_DEVIATION 37.08 | 57.4 score on a scale STANDARD_DEVIATION 58.35 | 43.7 score on a scale STANDARD_DEVIATION 31.43 | 43.9 score on a scale STANDARD_DEVIATION 35.74 | 37.1 score on a scale STANDARD_DEVIATION 34.51 | 45.8 score on a scale STANDARD_DEVIATION 50.31 |
| IGA Mean Scores at Baseline | 2.8 score on a scale STANDARD_DEVIATION 0.55 | 2.9 score on a scale STANDARD_DEVIATION 0.56 | 3.0 score on a scale STANDARD_DEVIATION 0.58 | 2.9 score on a scale STANDARD_DEVIATION 0.56 | 3.0 score on a scale STANDARD_DEVIATION 0.53 | 2.8 score on a scale STANDARD_DEVIATION 0.57 | 2.9 score on a scale STANDARD_DEVIATION 0.61 |
| Investigator Global Assessment (IGA) Categorical Scores at Baseline 0 - Clear | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Investigator Global Assessment (IGA) Categorical Scores at Baseline 1 - Almost Clear | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Investigator Global Assessment (IGA) Categorical Scores at Baseline 2 - Mild | 9 Participants | 45 Participants | 1 Participants | 12 Participants | 8 Participants | 8 Participants | 7 Participants |
| Investigator Global Assessment (IGA) Categorical Scores at Baseline 3 - Moderate | 21 Participants | 157 Participants | 5 Participants | 45 Participants | 44 Participants | 21 Participants | 21 Participants |
| Investigator Global Assessment (IGA) Categorical Scores at Baseline 4 - Severe | 2 Participants | 28 Participants | 1 Participants | 8 Participants | 9 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 15 Participants | 0 Participants | 4 Participants | 2 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 28 Participants | 1 Participants | 9 Participants | 8 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 3 Participants | 0 Participants | 0 Participants | 2 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 3 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) White | 25 Participants | 180 Participants | 6 Participants | 51 Participants | 48 Participants | 23 Participants | 27 Participants |
| Sex: Female, Male Female | 23 Participants | 140 Participants | 5 Participants | 37 Participants | 39 Participants | 21 Participants | 15 Participants |
| Sex: Female, Male Male | 9 Participants | 90 Participants | 2 Participants | 28 Participants | 22 Participants | 11 Participants | 18 Participants |
| Worst Itch Numerical Rating Scale (WI-NRS) Baseline Score | 5.0 score on a scale STANDARD_DEVIATION 2.8 | 5.7 score on a scale STANDARD_DEVIATION 2.74 | 6.7 score on a scale STANDARD_DEVIATION 2.56 | 5.8 score on a scale STANDARD_DEVIATION 2.45 | 5.8 score on a scale STANDARD_DEVIATION 2.75 | 6.0 score on a scale STANDARD_DEVIATION 3.19 | 5.5 score on a scale STANDARD_DEVIATION 2.83 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 65 | 0 / 61 | 0 / 32 | 0 / 33 | 0 / 32 |
| other Total, other adverse events | 0 / 7 | 2 / 65 | 2 / 61 | 3 / 32 | 2 / 33 | 1 / 32 |
| serious Total, serious adverse events | 0 / 7 | 0 / 65 | 0 / 61 | 0 / 32 | 0 / 33 | 0 / 32 |
Outcome results
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.
Time frame: Up to 3 weeks
Population: All treated participants in Cohort 1 are included.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: ARQ-252 Cream 0.3% QD | Cohort 1: Number of Participants With ≥1 Adverse Event (AE) | 1 Participants |
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.
Time frame: Up to 3 weeks
Population: All treated participants in Cohort 1 are included.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: ARQ-252 Cream 0.3% QD | Cohort 1: Number of Participants With ≥1 Serious Adverse Event (SAE) | 0 Participants |
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.
Time frame: Up to 3 weeks
Population: All treated participants in Cohort 1 are included.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: ARQ-252 Cream 0.3% QD | Cohort 1: Number of Participants With an Application Site Reaction | 0 Participants |
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.
Time frame: Up to 3 weeks
Population: All treated participants in Cohort 1 are included.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: ARQ-252 Cream 0.3% QD | Cohort 1: Number of Participants With Significant Changes in Chemistry Laboratory Parameters | 0 Participants |
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.
Time frame: Up to 3 weeks
Population: All treated participants in Cohort 1 are included.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: ARQ-252 Cream 0.3% QD | Cohort 1: Number of Participants With Significant Changes in Hematology Laboratory Parameters | 0 Participants |
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.
Time frame: Week 12
Population: Participants from Cohort 2 with data available are included. Note that all Cohort 2 Vehicle Cream (QD or BID) participants are pooled for analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1: ARQ-252 Cream 0.3% QD | Cohort 2: Investigator's Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' at Week 12 | 0 Participants |
| Cohort 2: ARQ-252 Cream 0.3% QD | Cohort 2: Investigator's Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' at Week 12 | 23 Participants |
| Cohort 2: ARQ-252 Cream 0.3% BID | Cohort 2: Investigator's Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' at Week 12 | 15 Participants |
| Cohort 2: ARQ-252 Cream 0.1% QD | Cohort 2: Investigator's Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' at Week 12 | 10 Participants |
| Cohort 2: Vehicle Cream QD | Cohort 2: Investigator's Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' at Week 12 | 16 Participants |
p-value: 0.578895% CI: [0.49, 2.53]Cochran-Mantel-Haenszel
p-value: 0.648895% CI: [0.33, 2.17]Cochran-Mantel-Haenszel
p-value: 0.565395% CI: [0.32, 2.25]Cochran-Mantel-Haenszel
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.
Time frame: Weeks 2, 4, 8, and 12
Population: All randomized participants in Cohort 2 with data available and who had baseline WI-NRS scores ≥4 are included.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 2: ARQ-252 Cream 0.3% QD | Cohort 2: Achievement of ≥4-point Reduction From Baseline in Worst Itch Numeric Rating Scale (WI-NRS) Pruritus Score | Week 2 | 21 Participants |
| Cohort 2: ARQ-252 Cream 0.3% QD | Cohort 2: Achievement of ≥4-point Reduction From Baseline in Worst Itch Numeric Rating Scale (WI-NRS) Pruritus Score | Week 4 | 23 Participants |
| Cohort 2: ARQ-252 Cream 0.3% QD | Cohort 2: Achievement of ≥4-point Reduction From Baseline in Worst Itch Numeric Rating Scale (WI-NRS) Pruritus Score | Week 8 | 29 Participants |
| Cohort 2: ARQ-252 Cream 0.3% QD | Cohort 2: Achievement of ≥4-point Reduction From Baseline in Worst Itch Numeric Rating Scale (WI-NRS) Pruritus Score | Week 12 | 30 Participants |
| Cohort 2: ARQ-252 Cream 0.3% BID | Cohort 2: Achievement of ≥4-point Reduction From Baseline in Worst Itch Numeric Rating Scale (WI-NRS) Pruritus Score | Week 4 | 19 Participants |
| Cohort 2: ARQ-252 Cream 0.3% BID | Cohort 2: Achievement of ≥4-point Reduction From Baseline in Worst Itch Numeric Rating Scale (WI-NRS) Pruritus Score | Week 8 | 20 Participants |
| Cohort 2: ARQ-252 Cream 0.3% BID | Cohort 2: Achievement of ≥4-point Reduction From Baseline in Worst Itch Numeric Rating Scale (WI-NRS) Pruritus Score | Week 12 | 21 Participants |
| Cohort 2: ARQ-252 Cream 0.3% BID | Cohort 2: Achievement of ≥4-point Reduction From Baseline in Worst Itch Numeric Rating Scale (WI-NRS) Pruritus Score | Week 2 | 20 Participants |
| Cohort 2: ARQ-252 Cream 0.1% QD | Cohort 2: Achievement of ≥4-point Reduction From Baseline in Worst Itch Numeric Rating Scale (WI-NRS) Pruritus Score | Week 8 | 15 Participants |
| Cohort 2: ARQ-252 Cream 0.1% QD | Cohort 2: Achievement of ≥4-point Reduction From Baseline in Worst Itch Numeric Rating Scale (WI-NRS) Pruritus Score | Week 4 | 15 Participants |
| Cohort 2: ARQ-252 Cream 0.1% QD | Cohort 2: Achievement of ≥4-point Reduction From Baseline in Worst Itch Numeric Rating Scale (WI-NRS) Pruritus Score | Week 12 | 16 Participants |
| Cohort 2: ARQ-252 Cream 0.1% QD | Cohort 2: Achievement of ≥4-point Reduction From Baseline in Worst Itch Numeric Rating Scale (WI-NRS) Pruritus Score | Week 2 | 14 Participants |
| Cohort 2: Vehicle Cream QD | Cohort 2: Achievement of ≥4-point Reduction From Baseline in Worst Itch Numeric Rating Scale (WI-NRS) Pruritus Score | Week 12 | 16 Participants |
| Cohort 2: Vehicle Cream QD | Cohort 2: Achievement of ≥4-point Reduction From Baseline in Worst Itch Numeric Rating Scale (WI-NRS) Pruritus Score | Week 4 | 14 Participants |
| Cohort 2: Vehicle Cream QD | Cohort 2: Achievement of ≥4-point Reduction From Baseline in Worst Itch Numeric Rating Scale (WI-NRS) Pruritus Score | Week 2 | 12 Participants |
| Cohort 2: Vehicle Cream QD | Cohort 2: Achievement of ≥4-point Reduction From Baseline in Worst Itch Numeric Rating Scale (WI-NRS) Pruritus Score | Week 8 | 15 Participants |
Comparison: Week 2p-value: 0.266295% CI: [0.64, 4.7]Cochran-Mantel-Haenszel
Comparison: Week 2p-value: 0.379895% CI: [0.59, 4]Cochran-Mantel-Haenszel
Comparison: Week 2p-value: 0.061195% CI: [0.9, 11.17]Cochran-Mantel-Haenszel
Comparison: Week 4p-value: 0.312995% CI: [0.64, 3.93]Cochran-Mantel-Haenszel
Comparison: Week 4p-value: 0.958695% CI: [0.35, 2.74]Cochran-Mantel-Haenszel
Comparison: Week 4p-value: 0.064395% CI: [0.87, 15.29]Cochran-Mantel-Haenszel
Comparison: Week 8p-value: 0.093295% CI: [0.84, 6.88]Cochran-Mantel-Haenszel
Comparison: Week 8p-value: 0.57395% CI: [0.44, 4.59]Cochran-Mantel-Haenszel
Comparison: Week 8p-value: 0.038995% CI: [0.96, 25.66]Cochran-Mantel-Haenszel
Comparison: Week 12p-value: 0.281395% CI: [0.6, 5.53]Cochran-Mantel-Haenszel
Comparison: Week 12p-value: 0.684195% CI: [0.17, 3.03]Cochran-Mantel-Haenszel
Comparison: Week 12p-value: 0.311395% CI: [0.49, 9.21]Cochran-Mantel-Haenszel
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.
Time frame: Weeks 2, 4, 8 and 12
Population: Participants from Cohort 2 with data available are included. Note that all Cohort 2 Vehicle Cream (QD or BID) participants are pooled for analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 2: ARQ-252 Cream 0.3% QD | Cohort 2: Achievement of at Least a 2-point Improvement in IGA Score From Baseline | Week 2 | 9 Participants |
| Cohort 2: ARQ-252 Cream 0.3% QD | Cohort 2: Achievement of at Least a 2-point Improvement in IGA Score From Baseline | Week 4 | 15 Participants |
| Cohort 2: ARQ-252 Cream 0.3% QD | Cohort 2: Achievement of at Least a 2-point Improvement in IGA Score From Baseline | Week 8 | 13 Participants |
| Cohort 2: ARQ-252 Cream 0.3% QD | Cohort 2: Achievement of at Least a 2-point Improvement in IGA Score From Baseline | Week 12 | 22 Participants |
| Cohort 2: ARQ-252 Cream 0.3% BID | Cohort 2: Achievement of at Least a 2-point Improvement in IGA Score From Baseline | Week 4 | 14 Participants |
| Cohort 2: ARQ-252 Cream 0.3% BID | Cohort 2: Achievement of at Least a 2-point Improvement in IGA Score From Baseline | Week 8 | 17 Participants |
| Cohort 2: ARQ-252 Cream 0.3% BID | Cohort 2: Achievement of at Least a 2-point Improvement in IGA Score From Baseline | Week 12 | 16 Participants |
| Cohort 2: ARQ-252 Cream 0.3% BID | Cohort 2: Achievement of at Least a 2-point Improvement in IGA Score From Baseline | Week 2 | 6 Participants |
| Cohort 2: ARQ-252 Cream 0.1% QD | Cohort 2: Achievement of at Least a 2-point Improvement in IGA Score From Baseline | Week 8 | 4 Participants |
| Cohort 2: ARQ-252 Cream 0.1% QD | Cohort 2: Achievement of at Least a 2-point Improvement in IGA Score From Baseline | Week 4 | 2 Participants |
| Cohort 2: ARQ-252 Cream 0.1% QD | Cohort 2: Achievement of at Least a 2-point Improvement in IGA Score From Baseline | Week 12 | 5 Participants |
| Cohort 2: ARQ-252 Cream 0.1% QD | Cohort 2: Achievement of at Least a 2-point Improvement in IGA Score From Baseline | Week 2 | 3 Participants |
| Cohort 2: Vehicle Cream QD | Cohort 2: Achievement of at Least a 2-point Improvement in IGA Score From Baseline | Week 12 | 13 Participants |
| Cohort 2: Vehicle Cream QD | Cohort 2: Achievement of at Least a 2-point Improvement in IGA Score From Baseline | Week 4 | 13 Participants |
| Cohort 2: Vehicle Cream QD | Cohort 2: Achievement of at Least a 2-point Improvement in IGA Score From Baseline | Week 2 | 9 Participants |
| Cohort 2: Vehicle Cream QD | Cohort 2: Achievement of at Least a 2-point Improvement in IGA Score From Baseline | Week 8 | 14 Participants |
p-value: 0.723795% CI: [0.23, 2.44]Cochran-Mantel-Haenszel
p-value: 0.83895% CI: [0.17, 2.1]Cochran-Mantel-Haenszel
95% CI: [0.04, 2.55]
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.
Time frame: Weeks 2, 4, and 8
Population: Participants from Cohort 2 with data available are included. Note that all Cohort 2 Vehicle Cream (QD or BID) participants are pooled for analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 2: ARQ-252 Cream 0.3% QD | Cohort 2: Achievement of IGA Score of 'Clear' or 'Almost Clear' | Week 2 | 9 Participants |
| Cohort 2: ARQ-252 Cream 0.3% QD | Cohort 2: Achievement of IGA Score of 'Clear' or 'Almost Clear' | Week 8 | 15 Participants |
| Cohort 2: ARQ-252 Cream 0.3% QD | Cohort 2: Achievement of IGA Score of 'Clear' or 'Almost Clear' | Week 4 | 15 Participants |
| Cohort 2: ARQ-252 Cream 0.3% BID | Cohort 2: Achievement of IGA Score of 'Clear' or 'Almost Clear' | Week 2 | 7 Participants |
| Cohort 2: ARQ-252 Cream 0.3% BID | Cohort 2: Achievement of IGA Score of 'Clear' or 'Almost Clear' | Week 8 | 16 Participants |
| Cohort 2: ARQ-252 Cream 0.3% BID | Cohort 2: Achievement of IGA Score of 'Clear' or 'Almost Clear' | Week 4 | 13 Participants |
| Cohort 2: ARQ-252 Cream 0.1% QD | Cohort 2: Achievement of IGA Score of 'Clear' or 'Almost Clear' | Week 4 | 4 Participants |
| Cohort 2: ARQ-252 Cream 0.1% QD | Cohort 2: Achievement of IGA Score of 'Clear' or 'Almost Clear' | Week 2 | 3 Participants |
| Cohort 2: ARQ-252 Cream 0.1% QD | Cohort 2: Achievement of IGA Score of 'Clear' or 'Almost Clear' | Week 8 | 6 Participants |
| Cohort 2: Vehicle Cream QD | Cohort 2: Achievement of IGA Score of 'Clear' or 'Almost Clear' | Week 2 | 7 Participants |
| Cohort 2: Vehicle Cream QD | Cohort 2: Achievement of IGA Score of 'Clear' or 'Almost Clear' | Week 8 | 17 Participants |
| Cohort 2: Vehicle Cream QD | Cohort 2: Achievement of IGA Score of 'Clear' or 'Almost Clear' | Week 4 | 15 Participants |
Comparison: Week 2p-value: 0.960495% CI: [0.31, 3.07]Cochran-Mantel-Haenszel
Comparison: Week 2p-value: 0.975295% CI: [0.32, 3.25]Cochran-Mantel-Haenszel
Comparison: Week 2p-value: 0.507795% CI: [0.11, 3.03]Cochran-Mantel-Haenszel
Comparison: Week 4p-value: 0.591695% CI: [0.26, 2.15]Cochran-Mantel-Haenszel
Comparison: Week 4p-value: 0.33295% CI: [0.27, 1.57]Cochran-Mantel-Haenszel
Comparison: Week 4p-value: 0.192295% CI: [0.14, 1.57]Cochran-Mantel-Haenszel
Comparison: Week 8p-value: 0.418895% CI: [0.23, 1.81]Cochran-Mantel-Haenszel
Comparison: Week 8p-value: 0.55295% CI: [0.29, 1.92]Cochran-Mantel-Haenszel
Comparison: Week 8p-value: 0.6995% CI: [0.21, 2.2]Cochran-Mantel-Haenszel
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.
Time frame: Weeks 2, 4, 8 and 12
Population: Participants from Cohort 2 with data available are included. Note that all Cohort 2 Vehicle Cream (QD or BID) participants are pooled for analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1: ARQ-252 Cream 0.3% QD | Cohort 2: Achievement of IGA Score of 'Clear' or 'Almost Clear' PLUS at Least a 2-point Improvement From Baseline | Week 2 | 0 Participants |
| Cohort 1: ARQ-252 Cream 0.3% QD | Cohort 2: Achievement of IGA Score of 'Clear' or 'Almost Clear' PLUS at Least a 2-point Improvement From Baseline | Week 4 | 0 Participants |
| Cohort 1: ARQ-252 Cream 0.3% QD | Cohort 2: Achievement of IGA Score of 'Clear' or 'Almost Clear' PLUS at Least a 2-point Improvement From Baseline | Week 8 | 0 Participants |
| Cohort 1: ARQ-252 Cream 0.3% QD | Cohort 2: Achievement of IGA Score of 'Clear' or 'Almost Clear' PLUS at Least a 2-point Improvement From Baseline | Week 12 | 0 Participants |
| Cohort 2: ARQ-252 Cream 0.3% QD | Cohort 2: Achievement of IGA Score of 'Clear' or 'Almost Clear' PLUS at Least a 2-point Improvement From Baseline | Week 2 | 8 Participants |
| Cohort 2: ARQ-252 Cream 0.3% QD | Cohort 2: Achievement of IGA Score of 'Clear' or 'Almost Clear' PLUS at Least a 2-point Improvement From Baseline | Week 12 | 20 Participants |
| Cohort 2: ARQ-252 Cream 0.3% QD | Cohort 2: Achievement of IGA Score of 'Clear' or 'Almost Clear' PLUS at Least a 2-point Improvement From Baseline | Week 4 | 14 Participants |
| Cohort 2: ARQ-252 Cream 0.3% QD | Cohort 2: Achievement of IGA Score of 'Clear' or 'Almost Clear' PLUS at Least a 2-point Improvement From Baseline | Week 8 | 12 Participants |
| Cohort 2: ARQ-252 Cream 0.3% BID | Cohort 2: Achievement of IGA Score of 'Clear' or 'Almost Clear' PLUS at Least a 2-point Improvement From Baseline | Week 12 | 13 Participants |
| Cohort 2: ARQ-252 Cream 0.3% BID | Cohort 2: Achievement of IGA Score of 'Clear' or 'Almost Clear' PLUS at Least a 2-point Improvement From Baseline | Week 4 | 11 Participants |
| Cohort 2: ARQ-252 Cream 0.3% BID | Cohort 2: Achievement of IGA Score of 'Clear' or 'Almost Clear' PLUS at Least a 2-point Improvement From Baseline | Week 8 | 15 Participants |
| Cohort 2: ARQ-252 Cream 0.3% BID | Cohort 2: Achievement of IGA Score of 'Clear' or 'Almost Clear' PLUS at Least a 2-point Improvement From Baseline | Week 2 | 6 Participants |
| Cohort 2: ARQ-252 Cream 0.1% QD | Cohort 2: Achievement of IGA Score of 'Clear' or 'Almost Clear' PLUS at Least a 2-point Improvement From Baseline | Week 2 | 2 Participants |
| Cohort 2: ARQ-252 Cream 0.1% QD | Cohort 2: Achievement of IGA Score of 'Clear' or 'Almost Clear' PLUS at Least a 2-point Improvement From Baseline | Week 4 | 2 Participants |
| Cohort 2: ARQ-252 Cream 0.1% QD | Cohort 2: Achievement of IGA Score of 'Clear' or 'Almost Clear' PLUS at Least a 2-point Improvement From Baseline | Week 12 | 5 Participants |
| Cohort 2: ARQ-252 Cream 0.1% QD | Cohort 2: Achievement of IGA Score of 'Clear' or 'Almost Clear' PLUS at Least a 2-point Improvement From Baseline | Week 8 | 4 Participants |
| Cohort 2: Vehicle Cream QD | Cohort 2: Achievement of IGA Score of 'Clear' or 'Almost Clear' PLUS at Least a 2-point Improvement From Baseline | Week 12 | 12 Participants |
| Cohort 2: Vehicle Cream QD | Cohort 2: Achievement of IGA Score of 'Clear' or 'Almost Clear' PLUS at Least a 2-point Improvement From Baseline | Week 8 | 14 Participants |
| Cohort 2: Vehicle Cream QD | Cohort 2: Achievement of IGA Score of 'Clear' or 'Almost Clear' PLUS at Least a 2-point Improvement From Baseline | Week 4 | 13 Participants |
| Cohort 2: Vehicle Cream QD | Cohort 2: Achievement of IGA Score of 'Clear' or 'Almost Clear' PLUS at Least a 2-point Improvement From Baseline | Week 2 | 7 Participants |
p-value: 0.503395% CI: [0.25, 2.78]Cochran-Mantel-Haenszel
p-value: 0.497595% CI: [0.25, 2.79]Cochran-Mantel-Haenszel
95% CI: [0.04, 2.55]Cochran-Mantel-Haenszel
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.
Time frame: Weeks 2, 4, 8, and 12
Population: All participants in Cohort 2 with data available are included.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 2: ARQ-252 Cream 0.3% QD | Cohort 2: Change From Baseline in Hand Eczema Severity Index (HECSI) Score | Week 2 | -18.3 score on a scale | Standard Deviation 27.39 |
| Cohort 2: ARQ-252 Cream 0.3% QD | Cohort 2: Change From Baseline in Hand Eczema Severity Index (HECSI) Score | Week 4 | -21.3 score on a scale | Standard Deviation 28.38 |
| Cohort 2: ARQ-252 Cream 0.3% QD | Cohort 2: Change From Baseline in Hand Eczema Severity Index (HECSI) Score | Week 8 | -22.7 score on a scale | Standard Deviation 29.5 |
| Cohort 2: ARQ-252 Cream 0.3% QD | Cohort 2: Change From Baseline in Hand Eczema Severity Index (HECSI) Score | Week 12 | -25.8 score on a scale | Standard Deviation 30.25 |
| Cohort 2: ARQ-252 Cream 0.3% BID | Cohort 2: Change From Baseline in Hand Eczema Severity Index (HECSI) Score | Week 4 | -21.0 score on a scale | Standard Deviation 24.78 |
| Cohort 2: ARQ-252 Cream 0.3% BID | Cohort 2: Change From Baseline in Hand Eczema Severity Index (HECSI) Score | Week 8 | -19.7 score on a scale | Standard Deviation 27.12 |
| Cohort 2: ARQ-252 Cream 0.3% BID | Cohort 2: Change From Baseline in Hand Eczema Severity Index (HECSI) Score | Week 12 | -26.3 score on a scale | Standard Deviation 29.85 |
| Cohort 2: ARQ-252 Cream 0.3% BID | Cohort 2: Change From Baseline in Hand Eczema Severity Index (HECSI) Score | Week 2 | -13.6 score on a scale | Standard Deviation 21.67 |
| Cohort 2: ARQ-252 Cream 0.1% QD | Cohort 2: Change From Baseline in Hand Eczema Severity Index (HECSI) Score | Week 8 | -8.3 score on a scale | Standard Deviation 25.16 |
| Cohort 2: ARQ-252 Cream 0.1% QD | Cohort 2: Change From Baseline in Hand Eczema Severity Index (HECSI) Score | Week 4 | -8.8 score on a scale | Standard Deviation 20.22 |
| Cohort 2: ARQ-252 Cream 0.1% QD | Cohort 2: Change From Baseline in Hand Eczema Severity Index (HECSI) Score | Week 12 | -14.5 score on a scale | Standard Deviation 19.19 |
| Cohort 2: ARQ-252 Cream 0.1% QD | Cohort 2: Change From Baseline in Hand Eczema Severity Index (HECSI) Score | Week 2 | -4.0 score on a scale | Standard Deviation 22.37 |
| Cohort 2: Vehicle Cream QD | Cohort 2: Change From Baseline in Hand Eczema Severity Index (HECSI) Score | Week 12 | -18.6 score on a scale | Standard Deviation 36.12 |
| Cohort 2: Vehicle Cream QD | Cohort 2: Change From Baseline in Hand Eczema Severity Index (HECSI) Score | Week 4 | -14.6 score on a scale | Standard Deviation 30.89 |
| Cohort 2: Vehicle Cream QD | Cohort 2: Change From Baseline in Hand Eczema Severity Index (HECSI) Score | Week 2 | -12.4 score on a scale | Standard Deviation 31.84 |
| Cohort 2: Vehicle Cream QD | Cohort 2: Change From Baseline in Hand Eczema Severity Index (HECSI) Score | Week 8 | -17.8 score on a scale | Standard Deviation 33.15 |
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.
Time frame: Weeks 2, 4, 8, and 12
Population: All participants in Cohort 2 are included.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 2: ARQ-252 Cream 0.3% QD | Cohort 2: Change From Baseline in Investigator's Global Assessment (IGA) Score | Week 2 | -0.55 units on a scale | Standard Deviation 0.107 |
| Cohort 2: ARQ-252 Cream 0.3% QD | Cohort 2: Change From Baseline in Investigator's Global Assessment (IGA) Score | Week 4 | -0.68 units on a scale | Standard Deviation 0.126 |
| Cohort 2: ARQ-252 Cream 0.3% QD | Cohort 2: Change From Baseline in Investigator's Global Assessment (IGA) Score | Week 8 | -0.73 units on a scale | Standard Deviation 0.149 |
| Cohort 2: ARQ-252 Cream 0.3% QD | Cohort 2: Change From Baseline in Investigator's Global Assessment (IGA) Score | Week 12 | -1.04 units on a scale | Standard Deviation 0.149 |
| Cohort 2: ARQ-252 Cream 0.3% BID | Cohort 2: Change From Baseline in Investigator's Global Assessment (IGA) Score | Week 4 | -0.71 units on a scale | Standard Deviation 0.129 |
| Cohort 2: ARQ-252 Cream 0.3% BID | Cohort 2: Change From Baseline in Investigator's Global Assessment (IGA) Score | Week 8 | -0.84 units on a scale | Standard Deviation 0.153 |
| Cohort 2: ARQ-252 Cream 0.3% BID | Cohort 2: Change From Baseline in Investigator's Global Assessment (IGA) Score | Week 12 | -0.93 units on a scale | Standard Deviation 0.155 |
| Cohort 2: ARQ-252 Cream 0.3% BID | Cohort 2: Change From Baseline in Investigator's Global Assessment (IGA) Score | Week 2 | -0.50 units on a scale | Standard Deviation 0.109 |
| Cohort 2: ARQ-252 Cream 0.1% QD | Cohort 2: Change From Baseline in Investigator's Global Assessment (IGA) Score | Week 8 | -0.57 units on a scale | Standard Deviation 0.203 |
| Cohort 2: ARQ-252 Cream 0.1% QD | Cohort 2: Change From Baseline in Investigator's Global Assessment (IGA) Score | Week 4 | -0.58 units on a scale | Standard Deviation 0.174 |
| Cohort 2: ARQ-252 Cream 0.1% QD | Cohort 2: Change From Baseline in Investigator's Global Assessment (IGA) Score | Week 12 | -0.73 units on a scale | Standard Deviation 0.205 |
| Cohort 2: ARQ-252 Cream 0.1% QD | Cohort 2: Change From Baseline in Investigator's Global Assessment (IGA) Score | Week 2 | -0.35 units on a scale | Standard Deviation 0.143 |
| Cohort 2: Vehicle Cream QD | Cohort 2: Change From Baseline in Investigator's Global Assessment (IGA) Score | Week 12 | -0.80 units on a scale | Standard Deviation 0.15 |
| Cohort 2: Vehicle Cream QD | Cohort 2: Change From Baseline in Investigator's Global Assessment (IGA) Score | Week 4 | -0.72 units on a scale | Standard Deviation 0.129 |
| Cohort 2: Vehicle Cream QD | Cohort 2: Change From Baseline in Investigator's Global Assessment (IGA) Score | Week 2 | -0.48 units on a scale | Standard Deviation 0.105 |
| Cohort 2: Vehicle Cream QD | Cohort 2: Change From Baseline in Investigator's Global Assessment (IGA) Score | Week 8 | -0.78 units on a scale | Standard Deviation 0.15 |
p-value: 0.646495% CI: [-0.33, 0.21]ANCOVA
Comparison: Week 2p-value: 0.888195% CI: [-0.29, 0.25]ANCOVA
Comparison: Week 2p-value: 0.43695% CI: [-0.2, 0.46]ANCOVA
Comparison: Week 4p-value: 0.819695% CI: [-0.29, 0.36]ANCOVA
Comparison: Week 4p-value: 0.921795% CI: [-0.31, 0.34]ANCOVA
p-value: 0.478395% CI: [-0.25, 0.53]ANCOVA
Comparison: Week 8p-value: 0.772595% CI: [-0.32, 0.43]ANCOVA
Comparison: Week 8p-value: 0.786195% CI: [-0.43, 0.33]ANCOVA
Comparison: Week 8p-value: 0.352195% CI: [-0.24, 0.68]ANCOVA
Comparison: Week 12p-value: 0.216695% CI: [-0.62, 0.14]ANCOVA
Comparison: Week 12p-value: 0.526295% CI: [-0.52, 0.27]ANCOVA
Comparison: Week 12p-value: 0.757595% CI: [-0.39, 0.54]ANCOVA
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.
Time frame: Weeks 2, 4, 8, and 12
Population: All participants in Cohort 2 with data available are included.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 2: ARQ-252 Cream 0.3% QD | Cohort 2: Change From Baseline in Numerical Rating Scale (NRS) for Pain Score | Week 2 | -1.75 score on a scale | Standard Deviation 2.368 |
| Cohort 2: ARQ-252 Cream 0.3% QD | Cohort 2: Change From Baseline in Numerical Rating Scale (NRS) for Pain Score | Week 4 | -2.18 score on a scale | Standard Deviation 2.611 |
| Cohort 2: ARQ-252 Cream 0.3% QD | Cohort 2: Change From Baseline in Numerical Rating Scale (NRS) for Pain Score | Week 8 | -2.15 score on a scale | Standard Deviation 2.722 |
| Cohort 2: ARQ-252 Cream 0.3% QD | Cohort 2: Change From Baseline in Numerical Rating Scale (NRS) for Pain Score | Week 12 | -2.58 score on a scale | Standard Deviation 2.7 |
| Cohort 2: ARQ-252 Cream 0.3% BID | Cohort 2: Change From Baseline in Numerical Rating Scale (NRS) for Pain Score | Week 4 | -1.66 score on a scale | Standard Deviation 2.704 |
| Cohort 2: ARQ-252 Cream 0.3% BID | Cohort 2: Change From Baseline in Numerical Rating Scale (NRS) for Pain Score | Week 8 | -1.64 score on a scale | Standard Deviation 3.062 |
| Cohort 2: ARQ-252 Cream 0.3% BID | Cohort 2: Change From Baseline in Numerical Rating Scale (NRS) for Pain Score | Week 12 | -1.95 score on a scale | Standard Deviation 2.708 |
| Cohort 2: ARQ-252 Cream 0.3% BID | Cohort 2: Change From Baseline in Numerical Rating Scale (NRS) for Pain Score | Week 2 | -1.74 score on a scale | Standard Deviation 2.464 |
| Cohort 2: ARQ-252 Cream 0.1% QD | Cohort 2: Change From Baseline in Numerical Rating Scale (NRS) for Pain Score | Week 8 | -2.29 score on a scale | Standard Deviation 3.224 |
| Cohort 2: ARQ-252 Cream 0.1% QD | Cohort 2: Change From Baseline in Numerical Rating Scale (NRS) for Pain Score | Week 4 | -2.34 score on a scale | Standard Deviation 2.897 |
| Cohort 2: ARQ-252 Cream 0.1% QD | Cohort 2: Change From Baseline in Numerical Rating Scale (NRS) for Pain Score | Week 12 | -2.11 score on a scale | Standard Deviation 3.439 |
| Cohort 2: ARQ-252 Cream 0.1% QD | Cohort 2: Change From Baseline in Numerical Rating Scale (NRS) for Pain Score | Week 2 | -1.86 score on a scale | Standard Deviation 2.923 |
| Cohort 2: Vehicle Cream QD | Cohort 2: Change From Baseline in Numerical Rating Scale (NRS) for Pain Score | Week 12 | -1.06 score on a scale | Standard Deviation 2.602 |
| Cohort 2: Vehicle Cream QD | Cohort 2: Change From Baseline in Numerical Rating Scale (NRS) for Pain Score | Week 4 | -0.88 score on a scale | Standard Deviation 2.176 |
| Cohort 2: Vehicle Cream QD | Cohort 2: Change From Baseline in Numerical Rating Scale (NRS) for Pain Score | Week 2 | -0.71 score on a scale | Standard Deviation 2.298 |
| Cohort 2: Vehicle Cream QD | Cohort 2: Change From Baseline in Numerical Rating Scale (NRS) for Pain Score | Week 8 | -0.89 score on a scale | Standard Deviation 2.205 |
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').
Time frame: Weeks 2, 4, 8, 12, 13
Population: All participants in Cohort 2 with data available are included.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 2: ARQ-252 Cream 0.3% QD | Cohort 2: Change From Baseline in Overall Quality of Life in Hand Eczema Questionnaire (QOLHEQ) Score at Each Visit | Week 12 | -19.2 score on a scale | Standard Error 2.77 |
| Cohort 2: ARQ-252 Cream 0.3% QD | Cohort 2: Change From Baseline in Overall Quality of Life in Hand Eczema Questionnaire (QOLHEQ) Score at Each Visit | Week 4 | -17.4 score on a scale | Standard Error 2.44 |
| Cohort 2: ARQ-252 Cream 0.3% QD | Cohort 2: Change From Baseline in Overall Quality of Life in Hand Eczema Questionnaire (QOLHEQ) Score at Each Visit | Week 13 | -20.9 score on a scale | Standard Error 2.76 |
| Cohort 2: ARQ-252 Cream 0.3% QD | Cohort 2: Change From Baseline in Overall Quality of Life in Hand Eczema Questionnaire (QOLHEQ) Score at Each Visit | Week 8 | -16.6 score on a scale | Standard Error 2.59 |
| Cohort 2: ARQ-252 Cream 0.3% QD | Cohort 2: Change From Baseline in Overall Quality of Life in Hand Eczema Questionnaire (QOLHEQ) Score at Each Visit | Week 2 | -13.7 score on a scale | Standard Error 1.89 |
| Cohort 2: ARQ-252 Cream 0.3% BID | Cohort 2: Change From Baseline in Overall Quality of Life in Hand Eczema Questionnaire (QOLHEQ) Score at Each Visit | Week 8 | -19.6 score on a scale | Standard Error 2.61 |
| Cohort 2: ARQ-252 Cream 0.3% BID | Cohort 2: Change From Baseline in Overall Quality of Life in Hand Eczema Questionnaire (QOLHEQ) Score at Each Visit | Week 12 | -24.9 score on a scale | Standard Error 2.95 |
| Cohort 2: ARQ-252 Cream 0.3% BID | Cohort 2: Change From Baseline in Overall Quality of Life in Hand Eczema Questionnaire (QOLHEQ) Score at Each Visit | Week 13 | -22.9 score on a scale | Standard Error 2.89 |
| Cohort 2: ARQ-252 Cream 0.3% BID | Cohort 2: Change From Baseline in Overall Quality of Life in Hand Eczema Questionnaire (QOLHEQ) Score at Each Visit | Week 4 | -18.5 score on a scale | Standard Error 2.49 |
| Cohort 2: ARQ-252 Cream 0.3% BID | Cohort 2: Change From Baseline in Overall Quality of Life in Hand Eczema Questionnaire (QOLHEQ) Score at Each Visit | Week 2 | -15.1 score on a scale | Standard Error 1.92 |
| Cohort 2: ARQ-252 Cream 0.1% QD | Cohort 2: Change From Baseline in Overall Quality of Life in Hand Eczema Questionnaire (QOLHEQ) Score at Each Visit | Week 8 | -20.8 score on a scale | Standard Error 3.65 |
| Cohort 2: ARQ-252 Cream 0.1% QD | Cohort 2: Change From Baseline in Overall Quality of Life in Hand Eczema Questionnaire (QOLHEQ) Score at Each Visit | Week 2 | -11.0 score on a scale | Standard Error 2.64 |
| Cohort 2: ARQ-252 Cream 0.1% QD | Cohort 2: Change From Baseline in Overall Quality of Life in Hand Eczema Questionnaire (QOLHEQ) Score at Each Visit | Week 4 | -15.3 score on a scale | Standard Error 3.45 |
| Cohort 2: ARQ-252 Cream 0.1% QD | Cohort 2: Change From Baseline in Overall Quality of Life in Hand Eczema Questionnaire (QOLHEQ) Score at Each Visit | Week 12 | -22.3 score on a scale | Standard Error 3.89 |
| Cohort 2: ARQ-252 Cream 0.1% QD | Cohort 2: Change From Baseline in Overall Quality of Life in Hand Eczema Questionnaire (QOLHEQ) Score at Each Visit | Week 13 | -18.9 score on a scale | Standard Error 3.81 |
| Cohort 2: Vehicle Cream QD | Cohort 2: Change From Baseline in Overall Quality of Life in Hand Eczema Questionnaire (QOLHEQ) Score at Each Visit | Week 12 | -15.3 score on a scale | Standard Error 3.04 |
| Cohort 2: Vehicle Cream QD | Cohort 2: Change From Baseline in Overall Quality of Life in Hand Eczema Questionnaire (QOLHEQ) Score at Each Visit | Week 4 | -13.4 score on a scale | Standard Error 2.56 |
| Cohort 2: Vehicle Cream QD | Cohort 2: Change From Baseline in Overall Quality of Life in Hand Eczema Questionnaire (QOLHEQ) Score at Each Visit | Week 2 | -9.3 score on a scale | Standard Error 1.86 |
| Cohort 2: Vehicle Cream QD | Cohort 2: Change From Baseline in Overall Quality of Life in Hand Eczema Questionnaire (QOLHEQ) Score at Each Visit | Week 8 | -12.0 score on a scale | Standard Error 2.67 |
| Cohort 2: Vehicle Cream QD | Cohort 2: Change From Baseline in Overall Quality of Life in Hand Eczema Questionnaire (QOLHEQ) Score at Each Visit | Week 13 | -15.6 score on a scale | Standard Error 3.04 |
Comparison: Week 2p-value: 0.072595% CI: [-9.2, 0.4]ANCOVA
Comparison: Week 2p-value: 0.018395% CI: [-10.7, -1]ANCOVA
Comparison: Week 2p-value: 0.570195% CI: [-7.7, 4.3]ANCOVA
Comparison: Week 4p-value: 0.211695% CI: [-10.4, 2.3]ANCOVA
Comparison: Week 4p-value: 0.123595% CI: [-11.5, 1.4]ANCOVA
Comparison: Week 4p-value: 0.633495% CI: [-9.7, 5.9]ANCOVA
Comparison: Week 8p-value: 0.178895% CI: [-11.4, 2.1]ANCOVA
Comparison: Week 8p-value: 0.029295% CI: [-14.4, -0.8]ANCOVA
Comparison: Week 8p-value: 0.037195% CI: [-17.1, -0.5]ANCOVA
Comparison: Week 12p-value: 0.297195% CI: [-11.3, 3.5]ANCOVA
Comparison: Week 12p-value: 0.01595% CI: [-17.2, -1.9]ANCOVA
Comparison: Week 12p-value: 0.124595% CI: [-15.8, 1.9]ANCOVA
Comparison: Week 13p-value: 0.159195% CI: [-12.7, 2.1]ANCOVA
Comparison: Week 13p-value: 0.0695% CI: [-14.8, 0.3]ANCOVA
Comparison: Week 13p-value: 0.46495% CI: [-12, 5.5]ANCOVA
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).
Time frame: Weeks 2, 4, 8, 12
Population: All participants in Cohort 2 with data available are included.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 2: ARQ-252 Cream 0.3% QD | Cohort 2: Change From Baseline in Total Body Surface Area (BSA) Affected by Disease | Week 2 | -0.185 Percentage of Total BSA | Standard Error 0.0517 |
| Cohort 2: ARQ-252 Cream 0.3% QD | Cohort 2: Change From Baseline in Total Body Surface Area (BSA) Affected by Disease | Week 4 | -0.310 Percentage of Total BSA | Standard Error 0.0583 |
| Cohort 2: ARQ-252 Cream 0.3% QD | Cohort 2: Change From Baseline in Total Body Surface Area (BSA) Affected by Disease | Week 8 | -0.319 Percentage of Total BSA | Standard Error 0.0746 |
| Cohort 2: ARQ-252 Cream 0.3% QD | Cohort 2: Change From Baseline in Total Body Surface Area (BSA) Affected by Disease | Week 12 | -0.429 Percentage of Total BSA | Standard Error 0.0681 |
| Cohort 2: ARQ-252 Cream 0.3% BID | Cohort 2: Change From Baseline in Total Body Surface Area (BSA) Affected by Disease | Week 12 | -0.409 Percentage of Total BSA | Standard Error 0.0759 |
| Cohort 2: ARQ-252 Cream 0.3% BID | Cohort 2: Change From Baseline in Total Body Surface Area (BSA) Affected by Disease | Week 8 | -0.273 Percentage of Total BSA | Standard Error 0.0808 |
| Cohort 2: ARQ-252 Cream 0.3% BID | Cohort 2: Change From Baseline in Total Body Surface Area (BSA) Affected by Disease | Week 4 | -0.319 Percentage of Total BSA | Standard Error 0.0634 |
| Cohort 2: ARQ-252 Cream 0.3% BID | Cohort 2: Change From Baseline in Total Body Surface Area (BSA) Affected by Disease | Week 2 | -0.132 Percentage of Total BSA | Standard Error 0.0559 |
| Cohort 2: ARQ-252 Cream 0.1% QD | Cohort 2: Change From Baseline in Total Body Surface Area (BSA) Affected by Disease | Week 8 | -0.241 Percentage of Total BSA | Standard Error 0.1039 |
| Cohort 2: ARQ-252 Cream 0.1% QD | Cohort 2: Change From Baseline in Total Body Surface Area (BSA) Affected by Disease | Week 12 | -0.296 Percentage of Total BSA | Standard Error 0.0948 |
| Cohort 2: ARQ-252 Cream 0.1% QD | Cohort 2: Change From Baseline in Total Body Surface Area (BSA) Affected by Disease | Week 4 | -0.151 Percentage of Total BSA | Standard Error 0.0818 |
| Cohort 2: ARQ-252 Cream 0.1% QD | Cohort 2: Change From Baseline in Total Body Surface Area (BSA) Affected by Disease | Week 2 | -0.028 Percentage of Total BSA | Standard Error 0.0697 |
| Cohort 2: Vehicle Cream QD | Cohort 2: Change From Baseline in Total Body Surface Area (BSA) Affected by Disease | Week 4 | -0.139 Percentage of Total BSA | Standard Error 0.0616 |
| Cohort 2: Vehicle Cream QD | Cohort 2: Change From Baseline in Total Body Surface Area (BSA) Affected by Disease | Week 2 | -0.119 Percentage of Total BSA | Standard Error 0.0509 |
| Cohort 2: Vehicle Cream QD | Cohort 2: Change From Baseline in Total Body Surface Area (BSA) Affected by Disease | Week 12 | -0.307 Percentage of Total BSA | Standard Error 0.0751 |
| Cohort 2: Vehicle Cream QD | Cohort 2: Change From Baseline in Total Body Surface Area (BSA) Affected by Disease | Week 8 | -0.223 Percentage of Total BSA | Standard Error 0.0744 |
Comparison: Week 2p-value: 0.318495% CI: [-0.196, 0.064]ANCOVA
Comparison: Week 2p-value: 0.851495% CI: [-0.149, 0.123]ANCOVA
Comparison: Week 2p-value: 0.260395% CI: [-0.068, 0.249]ANCOVA
Comparison: Week 4p-value: 0.027395% CI: [-0.323, -0.019]ANCOVA
Comparison: Week 4p-value: 0.026695% CI: [-0.339, -0.021]ANCOVA
Comparison: Week 4p-value: 0.902395% CI: [-0.196, 0.173]ANCOVA
Comparison: Week 8p-value: 0.329895% CI: [-0.291, 0.098]ANCOVA
Comparison: Week 8p-value: 0.620595% CI: [-0.251, 0.15]ANCOVA
Comparison: Week 8p-value: 0.881795% CI: [-0.253, 0.217]ANCOVA
Comparison: Week 12p-value: 0.183795% CI: [-0.302, 0.058]ANCOVA
p-value: 0.289695% CI: [-0.293, 0.088]ANCOVA
Comparison: Week 12p-value: 0.91995% CI: [-0.205, 0.227]ANCOVA
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.
Time frame: Weeks 2, 4, 8, and 12
Population: All participants in Cohort 2 with data available are included.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 2: ARQ-252 Cream 0.3% QD | Cohort 2: Change From Baseline in Worst Itch Numeric Rating Scale (WI-NRS) Score | Week 2 | -2.43 score on a scale | Standard Error 0.365 |
| Cohort 2: ARQ-252 Cream 0.3% QD | Cohort 2: Change From Baseline in Worst Itch Numeric Rating Scale (WI-NRS) Score | Week 4 | -3.00 score on a scale | Standard Error 0.359 |
| Cohort 2: ARQ-252 Cream 0.3% QD | Cohort 2: Change From Baseline in Worst Itch Numeric Rating Scale (WI-NRS) Score | Week 8 | -3.39 score on a scale | Standard Error 0.338 |
| Cohort 2: ARQ-252 Cream 0.3% QD | Cohort 2: Change From Baseline in Worst Itch Numeric Rating Scale (WI-NRS) Score | Week 12 | -3.71 score on a scale | Standard Error 0.323 |
| Cohort 2: ARQ-252 Cream 0.3% BID | Cohort 2: Change From Baseline in Worst Itch Numeric Rating Scale (WI-NRS) Score | Week 4 | -2.48 score on a scale | Standard Error 0.372 |
| Cohort 2: ARQ-252 Cream 0.3% BID | Cohort 2: Change From Baseline in Worst Itch Numeric Rating Scale (WI-NRS) Score | Week 12 | -3.39 score on a scale | Standard Error 0.349 |
| Cohort 2: ARQ-252 Cream 0.3% BID | Cohort 2: Change From Baseline in Worst Itch Numeric Rating Scale (WI-NRS) Score | Week 2 | -2.25 score on a scale | Standard Error 0.36 |
| Cohort 2: ARQ-252 Cream 0.3% BID | Cohort 2: Change From Baseline in Worst Itch Numeric Rating Scale (WI-NRS) Score | Week 8 | -2.85 score on a scale | Standard Error 0.361 |
| Cohort 2: ARQ-252 Cream 0.1% QD | Cohort 2: Change From Baseline in Worst Itch Numeric Rating Scale (WI-NRS) Score | Week 8 | -3.48 score on a scale | Standard Error 0.476 |
| Cohort 2: ARQ-252 Cream 0.1% QD | Cohort 2: Change From Baseline in Worst Itch Numeric Rating Scale (WI-NRS) Score | Week 12 | -3.87 score on a scale | Standard Error 0.444 |
| Cohort 2: ARQ-252 Cream 0.1% QD | Cohort 2: Change From Baseline in Worst Itch Numeric Rating Scale (WI-NRS) Score | Week 2 | -3.16 score on a scale | Standard Error 0.469 |
| Cohort 2: ARQ-252 Cream 0.1% QD | Cohort 2: Change From Baseline in Worst Itch Numeric Rating Scale (WI-NRS) Score | Week 4 | -3.75 score on a scale | Standard Error 0.504 |
| Cohort 2: Vehicle Cream QD | Cohort 2: Change From Baseline in Worst Itch Numeric Rating Scale (WI-NRS) Score | Week 12 | -3.08 score on a scale | Standard Error 0.354 |
| Cohort 2: Vehicle Cream QD | Cohort 2: Change From Baseline in Worst Itch Numeric Rating Scale (WI-NRS) Score | Week 2 | -1.80 score on a scale | Standard Error 0.355 |
| Cohort 2: Vehicle Cream QD | Cohort 2: Change From Baseline in Worst Itch Numeric Rating Scale (WI-NRS) Score | Week 4 | -2.49 score on a scale | Standard Error 0.373 |
| Cohort 2: Vehicle Cream QD | Cohort 2: Change From Baseline in Worst Itch Numeric Rating Scale (WI-NRS) Score | Week 8 | -2.64 score on a scale | Standard Error 0.362 |
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.
Time frame: Weeks 2, 4, 8, and 12
Population: All participants in Cohort 2 who had baseline NRS Pain scores ≥4 and with data available are included.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 2: ARQ-252 Cream 0.3% QD | Cohort 2: The Rate of Achievement of ≥4-point Reduction From Baseline in Pain Numerical Rating Scale (NRS) Score | Week 2 | 15 Participants |
| Cohort 2: ARQ-252 Cream 0.3% QD | Cohort 2: The Rate of Achievement of ≥4-point Reduction From Baseline in Pain Numerical Rating Scale (NRS) Score | Week 4 | 17 Participants |
| Cohort 2: ARQ-252 Cream 0.3% QD | Cohort 2: The Rate of Achievement of ≥4-point Reduction From Baseline in Pain Numerical Rating Scale (NRS) Score | Week 8 | 17 Participants |
| Cohort 2: ARQ-252 Cream 0.3% QD | Cohort 2: The Rate of Achievement of ≥4-point Reduction From Baseline in Pain Numerical Rating Scale (NRS) Score | Week 12 | 20 Participants |
| Cohort 2: ARQ-252 Cream 0.3% BID | Cohort 2: The Rate of Achievement of ≥4-point Reduction From Baseline in Pain Numerical Rating Scale (NRS) Score | Week 4 | 10 Participants |
| Cohort 2: ARQ-252 Cream 0.3% BID | Cohort 2: The Rate of Achievement of ≥4-point Reduction From Baseline in Pain Numerical Rating Scale (NRS) Score | Week 8 | 10 Participants |
| Cohort 2: ARQ-252 Cream 0.3% BID | Cohort 2: The Rate of Achievement of ≥4-point Reduction From Baseline in Pain Numerical Rating Scale (NRS) Score | Week 12 | 10 Participants |
| Cohort 2: ARQ-252 Cream 0.3% BID | Cohort 2: The Rate of Achievement of ≥4-point Reduction From Baseline in Pain Numerical Rating Scale (NRS) Score | Week 2 | 8 Participants |
| Cohort 2: ARQ-252 Cream 0.1% QD | Cohort 2: The Rate of Achievement of ≥4-point Reduction From Baseline in Pain Numerical Rating Scale (NRS) Score | Week 8 | 9 Participants |
| Cohort 2: ARQ-252 Cream 0.1% QD | Cohort 2: The Rate of Achievement of ≥4-point Reduction From Baseline in Pain Numerical Rating Scale (NRS) Score | Week 4 | 9 Participants |
| Cohort 2: ARQ-252 Cream 0.1% QD | Cohort 2: The Rate of Achievement of ≥4-point Reduction From Baseline in Pain Numerical Rating Scale (NRS) Score | Week 12 | 9 Participants |
| Cohort 2: ARQ-252 Cream 0.1% QD | Cohort 2: The Rate of Achievement of ≥4-point Reduction From Baseline in Pain Numerical Rating Scale (NRS) Score | Week 2 | 8 Participants |
| Cohort 2: Vehicle Cream QD | Cohort 2: The Rate of Achievement of ≥4-point Reduction From Baseline in Pain Numerical Rating Scale (NRS) Score | Week 12 | 5 Participants |
| Cohort 2: Vehicle Cream QD | Cohort 2: The Rate of Achievement of ≥4-point Reduction From Baseline in Pain Numerical Rating Scale (NRS) Score | Week 4 | 5 Participants |
| Cohort 2: Vehicle Cream QD | Cohort 2: The Rate of Achievement of ≥4-point Reduction From Baseline in Pain Numerical Rating Scale (NRS) Score | Week 2 | 3 Participants |
| Cohort 2: Vehicle Cream QD | Cohort 2: The Rate of Achievement of ≥4-point Reduction From Baseline in Pain Numerical Rating Scale (NRS) Score | Week 8 | 4 Participants |
Comparison: Week 2p-value: 0.267495% CI: [0.46, 10.67]Cochran-Mantel-Haenszel
Comparison: Week 2p-value: 0.28595% CI: [0.44, 17.54]Cochran-Mantel-Haenszel
Comparison: Week 2p-value: 0.308695% CI: [0.42, 16.52]Cochran-Mantel-Haenszel
Comparison: Week 4p-value: 0.165595% CI: [0.46, 40.83]Cochran-Mantel-Haenszel
Comparison: Week 4p-value: 0.715495% CI: [0.26, 7.67]Cochran-Mantel-Haenszel
Comparison: Week 4p-value: 0.537195% CI: [0.27, 14.64]Cochran-Mantel-Haenszel
Comparison: Week 8p-value: 0.21795% CI: [0.43, 57.83]Cochran-Mantel-Haenszel
Comparison: Week 8p-value: 0.340895% CI: [0.41, 18.22]Cochran-Mantel-Haenszel
Comparison: Week 8p-value: 0.32795% CI: [0.41, 14.2]Cochran-Mantel-Haenszel
Comparison: Week 12p-value: 0.0719Cochran-Mantel-Haenszel
Comparison: Week 12p-value: 0.852795% CI: [0.07, 8.43]Cochran-Mantel-Haenszel
Comparison: Week 12p-value: 0.354595% CI: [0.37, 13.11]Cochran-Mantel-Haenszel