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Safety and Efficacy of ARQ-252 Cream in Subjects With Chronic Hand Eczema

Primary Purpose

Chronic Hand Eczema

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
ARQ-252 cream 0.3%
ARQ-252 cream 0.1%
ARQ-252 Vehicle Cream
Sponsored by
Arcutis Biotherapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hand Eczema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Arcutis Clinical Site 239
  • Arcutis Clinical Site 225
  • Arcutis Clinical Site 112
  • Arcutis Clinical Site 120
  • Arcutis Clinical Site 208
  • Arcutis Clinical Site 174
  • Arcutis Clinical Site 167
  • Arcutis Clinical Site 104
  • Arcutis Clinical Site 214
  • Arcutis Clinical Site 217
  • Arcutis Clinical Site 213
  • Arcutis Clinical Site 125
  • Arcutis Clinical Site 212
  • Arcutis Clinical Site 216
  • Arcutis Clinical Site 171
  • Arcutis Clinical Site 115
  • Arcutis Clinical Site 173
  • Arcutis Clinical Site 135
  • Arcutis Clinical Site 162
  • Arcutis Clinical Site 104
  • Arcutis Clinical Site 164
  • Arcutis Clinical Site 163
  • Arcutis Clinical Site 161
  • Arcutis Clinical Site 110
  • Arcutis Clinical Site 169
  • Arcutis Clinical Site 306
  • Arcutis Clinical Site 303
  • Arcutis Clinical Site 207
  • Arcutis Clinical Site 205
  • Arcutis Clinical Site 218
  • Arcutis Clinical Site 103
  • Arcutis Clinical Site 133
  • Arcutis Clinical Site 165
  • Arcutis Clinical Site 109
  • Arcutis Clinical Site 241
  • Arcutis Clinical Site 106
  • Arcutis Clinical Site 242

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Placebo Comparator

Arm Label

ARQ-252 cream 0.3% QD (once daily)

ARQ-252 cream 0.3% BID (twice daily)

ARQ-252 cream 0.1% QD (once daily)

Vehicle cream BID (twice daily)

Vehicle cream QD (once daily)

Arm Description

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Placebo Comparator

Outcomes

Primary Outcome Measures

Cohort 1: Safety, as measured by incidence of adverse events
The number of subjects reporting treatment-emergent adverse events
Cohort 1: Safety, as measured by severity of adverse events
The severity of treatment-emergent adverse events
Cohort 1: Safety, as measured by changes in hematology laboratory parameters
Number of subjects with changes in hematology laboratory parameters
Cohort 1: Safety, as measured by changes in chemistry laboratory parameters
Number of subjects with changes in chemistry laboratory parameters
Cohort 1: Safety, as measured by tolerability
The incidence of application site reactions as assessed by both the investigator and subject
Cohort 1: Safety, as measured by pharmacokinetics
Plasma drug concentrations at pre-dose will be summarized using descriptive statistics
Cohort 2: Investigator's Global Assessment (IGA) score of 'clear' or 'almost clear' at Week 12
The IGA is a static evaluation of qualitative overall chronic hand eczema severity. This global assessment scale is an ordinal scale with five severity grades (reported only in integers of 0 to 4). Each IGA Severity Score is defined by distinct and clinically relevant morphologic descriptions that minimizes inter-observer variability.

Secondary Outcome Measures

Cohort 2: The rate of achievement of Investigator's Global Assessment (IGA) of 'clear' or 'almost clear' PLUS at least a 2-point improvement from Baseline
The IGA is a static evaluation of qualitative overall chronic hand eczema severity. Each IGA Severity Score is defined by distinct and clinically relevant morphologic descriptions that minimizes inter-observer variability.This global assessment scale is an ordinal scale with five severity grades ranging from 0-Clear to 4-Severe.
Cohort 2: The rate of achievement of at least a 2-point improvement in Investigator's Global Assessment (IGA) from Baseline
The IGA is a static evaluation of qualitative overall chronic hand eczema severity. Each IGA Severity Score is defined by distinct and clinically relevant morphologic descriptions that minimizes inter-observer variability.This global assessment scale is an ordinal scale with five severity grades ranging from 0-Clear to 4-Severe.
Cohort 2: Achievement of Investigator's Global Assessment (IGA) of 'clear' or 'almost clear'
The IGA is a static evaluation of qualitative overall chronic hand eczema severity. Each IGA Severity Score is defined by distinct and clinically relevant morphologic descriptions that minimizes inter-observer variability.This global assessment scale is an ordinal scale with five severity grades ranging from 0-Clear to 4-Severe.
Cohort 2: Time to Investigator's Global Assessment (IGA) of 'clear' or 'almost clear'
The IGA is a static evaluation of qualitative overall chronic hand eczema severity. Each IGA Severity Score is defined by distinct and clinically relevant morphologic descriptions that minimizes inter-observer variability.This global assessment scale is an ordinal scale with five severity grades ranging from 0-Clear to 4-Severe.
Cohort 2: Change in Time to Investigator's Global Assessment (IGA) score compared to Baseline
The IGA is a static evaluation of qualitative overall chronic hand eczema severity. Each IGA Severity Score is defined by distinct and clinically relevant morphologic descriptions that minimizes inter-observer variability.This global assessment scale is an ordinal scale with five severity grades ranging from 0-Clear to 4-Severe.
Cohort 2: Change in Worst Itch Numeric Rating Scale (WI-NRS) pruritus score compared to Baseline
The WI-NRS has been developed as a simple, single item to assess the patient-reported severity of this symptom at its highest intensity during the previous 24-hour period. The WI-NRS will be determined by asking the subject's assessment of worst itch over the past 24 hours. The scale is from '0 to 10' ("no itch" to "worst imaginable itch").
Cohort 2: The rate of achievement of ≥4-point reduction from Baseline in Worst Itch Numeric Rating Scale (WI-NRS) pruritus score in subjects with Baseline WI-NRS pruritus score of at least 4
The WI-NRS has been developed as a simple, single item to assess the patient-reported severity of this symptom at its highest intensity during the previous 24-hour period. The WI-NRS will be determined by asking the subject's assessment of worst itch over the past 24 hours. The scale is from '0 to 10' ("no itch" to "worst imaginable itch").
Cohort 2: Time to the first achievement of ≥4-point reduction from Baseline in Worst Itch Numeric Rating Scale (WI-NRS) pruritus score in subjects with Baseline WI-NRS pruritus score of at least 4
The WI-NRS has been developed as a simple, single item to assess the patient-reported severity of this symptom at its highest intensity during the previous 24-hour period. The WI-NRS will be determined by asking the subject's assessment of worst itch over the past 24 hours. The scale is from '0 to 10' ("no itch" to "worst imaginable itch").
Cohort 2: Percent change in Hand Eczema Severity Index (HECSI) score compared to Baseline
HECSI is an instrument used in clinical trials to rate the severity of 6 clinical signs of hand eczema and the extent of the lesions on each of 5 hand areas by use of standard scales. The total HECSI score is based on a 4-point severity scale ranging from 0 (none/absent) to 3 (severe) and a 5-point scale rating the affected area(s) ranging from 0 (0% affected area) to 4 (76% to 100% affected area).
Cohort 2: Change in Numerical Rating Scale (NRS) for Pain score compared to Baseline
The NRS-Pain Scale is the most widely used instrument for pain screening. Subjects will select the number between 0 and 10 that fits best to their worst pain intensity over the past 24 hours, where 0 represents 'no pain at all' and 10 'the worst pain possible'.
Cohort 2: The rate of achievement of ≥4-point reduction from Baseline in Pain Numerical Rating Scale (NRS) score in subjects with Baseline Pain NRS score of at least 4
The NRS-Pain Scale is the most widely used instrument for pain screening. Subjects will select the number between 0 and 10 that fits best to their worst pain intensity over the past 24 hours, where 0 represents 'no pain at all' and 10 'the worst pain possible'.
Cohort 2: Time to the first achievement of ≥4-point reduction from Baseline in Pain Numerical Rating Scale (NRS) score in subjects with Baseline Pain NRS score of at least 4
The NRS-Pain Scale is the most widely used instrument for pain screening. Subjects will select the number between 0 and 10 that fits best to their worst pain intensity over the past 24 hours, where 0 represents 'no pain at all' and 10 'the worst pain possible'.
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 out 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.
Cohort 2: Percent Body Surface Area (BSA) affected by disease and percent change from baseline in BSA affected by disease
The BSA affected by chronic hand eczema will be determined by the subject's hand method, where the subject's hand (including fingers) surface area is assumed to equal 1% of body surface area.

Full Information

First Posted
April 30, 2020
Last Updated
August 4, 2022
Sponsor
Arcutis Biotherapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04378569
Brief Title
Safety and Efficacy of ARQ-252 Cream in Subjects With Chronic Hand Eczema
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
April 20, 2020 (Actual)
Primary Completion Date
February 24, 2021 (Actual)
Study Completion Date
February 24, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arcutis Biotherapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hand Eczema

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
230 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ARQ-252 cream 0.3% QD (once daily)
Arm Type
Active Comparator
Arm Description
Active Comparator
Arm Title
ARQ-252 cream 0.3% BID (twice daily)
Arm Type
Active Comparator
Arm Description
Active Comparator
Arm Title
ARQ-252 cream 0.1% QD (once daily)
Arm Type
Active Comparator
Arm Description
Active Comparator
Arm Title
Vehicle cream BID (twice daily)
Arm Type
Placebo Comparator
Arm Description
Placebo Comparator
Arm Title
Vehicle cream QD (once daily)
Arm Type
Placebo Comparator
Arm Description
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
ARQ-252 cream 0.3%
Intervention Description
ARQ-252 cream 0.3%
Intervention Type
Drug
Intervention Name(s)
ARQ-252 cream 0.1%
Intervention Description
ARQ-252 cream 0.1%
Intervention Type
Drug
Intervention Name(s)
ARQ-252 Vehicle Cream
Intervention Description
ARQ-252 Vehicle Cream
Primary Outcome Measure Information:
Title
Cohort 1: Safety, as measured by incidence of adverse events
Description
The number of subjects reporting treatment-emergent adverse events
Time Frame
Week 3
Title
Cohort 1: Safety, as measured by severity of adverse events
Description
The severity of treatment-emergent adverse events
Time Frame
Week 3
Title
Cohort 1: Safety, as measured by changes in hematology laboratory parameters
Description
Number of subjects with changes in hematology laboratory parameters
Time Frame
Week 3
Title
Cohort 1: Safety, as measured by changes in chemistry laboratory parameters
Description
Number of subjects with changes in chemistry laboratory parameters
Time Frame
Week 3
Title
Cohort 1: Safety, as measured by tolerability
Description
The incidence of application site reactions as assessed by both the investigator and subject
Time Frame
Week 3
Title
Cohort 1: Safety, as measured by pharmacokinetics
Description
Plasma drug concentrations at pre-dose will be summarized using descriptive statistics
Time Frame
Week 3
Title
Cohort 2: Investigator's Global Assessment (IGA) score of 'clear' or 'almost clear' at Week 12
Description
The IGA is a static evaluation of qualitative overall chronic hand eczema severity. This global assessment scale is an ordinal scale with five severity grades (reported only in integers of 0 to 4). Each IGA Severity Score is defined by distinct and clinically relevant morphologic descriptions that minimizes inter-observer variability.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Cohort 2: The rate of achievement of Investigator's Global Assessment (IGA) of 'clear' or 'almost clear' PLUS at least a 2-point improvement from Baseline
Description
The IGA is a static evaluation of qualitative overall chronic hand eczema severity. Each IGA Severity Score is defined by distinct and clinically relevant morphologic descriptions that minimizes inter-observer variability.This global assessment scale is an ordinal scale with five severity grades ranging from 0-Clear to 4-Severe.
Time Frame
Weeks 2, 4, 8 and 12
Title
Cohort 2: The rate of achievement of at least a 2-point improvement in Investigator's Global Assessment (IGA) from Baseline
Description
The IGA is a static evaluation of qualitative overall chronic hand eczema severity. Each IGA Severity Score is defined by distinct and clinically relevant morphologic descriptions that minimizes inter-observer variability.This global assessment scale is an ordinal scale with five severity grades ranging from 0-Clear to 4-Severe.
Time Frame
Weeks 2, 4, 8 and 12
Title
Cohort 2: Achievement of Investigator's Global Assessment (IGA) of 'clear' or 'almost clear'
Description
The IGA is a static evaluation of qualitative overall chronic hand eczema severity. Each IGA Severity Score is defined by distinct and clinically relevant morphologic descriptions that minimizes inter-observer variability.This global assessment scale is an ordinal scale with five severity grades ranging from 0-Clear to 4-Severe.
Time Frame
Weeks 2, 4, and 8
Title
Cohort 2: Time to Investigator's Global Assessment (IGA) of 'clear' or 'almost clear'
Description
The IGA is a static evaluation of qualitative overall chronic hand eczema severity. Each IGA Severity Score is defined by distinct and clinically relevant morphologic descriptions that minimizes inter-observer variability.This global assessment scale is an ordinal scale with five severity grades ranging from 0-Clear to 4-Severe.
Time Frame
Week 12
Title
Cohort 2: Change in Time to Investigator's Global Assessment (IGA) score compared to Baseline
Description
The IGA is a static evaluation of qualitative overall chronic hand eczema severity. Each IGA Severity Score is defined by distinct and clinically relevant morphologic descriptions that minimizes inter-observer variability.This global assessment scale is an ordinal scale with five severity grades ranging from 0-Clear to 4-Severe.
Time Frame
Weeks 2, 4, 8, and 12
Title
Cohort 2: Change in Worst Itch Numeric Rating Scale (WI-NRS) pruritus score compared to Baseline
Description
The WI-NRS has been developed as a simple, single item to assess the patient-reported severity of this symptom at its highest intensity during the previous 24-hour period. The WI-NRS will be determined by asking the subject's assessment of worst itch over the past 24 hours. The scale is from '0 to 10' ("no itch" to "worst imaginable itch").
Time Frame
Weeks 2, 4, 8, and 12
Title
Cohort 2: The rate of achievement of ≥4-point reduction from Baseline in Worst Itch Numeric Rating Scale (WI-NRS) pruritus score in subjects with Baseline WI-NRS pruritus score of at least 4
Description
The WI-NRS has been developed as a simple, single item to assess the patient-reported severity of this symptom at its highest intensity during the previous 24-hour period. The WI-NRS will be determined by asking the subject's assessment of worst itch over the past 24 hours. The scale is from '0 to 10' ("no itch" to "worst imaginable itch").
Time Frame
Weeks 2, 4, 8, and 12
Title
Cohort 2: Time to the first achievement of ≥4-point reduction from Baseline in Worst Itch Numeric Rating Scale (WI-NRS) pruritus score in subjects with Baseline WI-NRS pruritus score of at least 4
Description
The WI-NRS has been developed as a simple, single item to assess the patient-reported severity of this symptom at its highest intensity during the previous 24-hour period. The WI-NRS will be determined by asking the subject's assessment of worst itch over the past 24 hours. The scale is from '0 to 10' ("no itch" to "worst imaginable itch").
Time Frame
Week 12
Title
Cohort 2: Percent change in Hand Eczema Severity Index (HECSI) score compared to Baseline
Description
HECSI is an instrument used in clinical trials to rate the severity of 6 clinical signs of hand eczema and the extent of the lesions on each of 5 hand areas by use of standard scales. The total HECSI score is based on a 4-point severity scale ranging from 0 (none/absent) to 3 (severe) and a 5-point scale rating the affected area(s) ranging from 0 (0% affected area) to 4 (76% to 100% affected area).
Time Frame
Weeks 2, 4, 8, and 12
Title
Cohort 2: Change in Numerical Rating Scale (NRS) for Pain score compared to Baseline
Description
The NRS-Pain Scale is the most widely used instrument for pain screening. Subjects will select the number between 0 and 10 that fits best to their worst pain intensity over the past 24 hours, where 0 represents 'no pain at all' and 10 'the worst pain possible'.
Time Frame
Weeks 2, 4, 8, and 12
Title
Cohort 2: The rate of achievement of ≥4-point reduction from Baseline in Pain Numerical Rating Scale (NRS) score in subjects with Baseline Pain NRS score of at least 4
Description
The NRS-Pain Scale is the most widely used instrument for pain screening. Subjects will select the number between 0 and 10 that fits best to their worst pain intensity over the past 24 hours, where 0 represents 'no pain at all' and 10 'the worst pain possible'.
Time Frame
Weeks 2, 4, 8, and 12
Title
Cohort 2: Time to the first achievement of ≥4-point reduction from Baseline in Pain Numerical Rating Scale (NRS) score in subjects with Baseline Pain NRS score of at least 4
Description
The NRS-Pain Scale is the most widely used instrument for pain screening. Subjects will select the number between 0 and 10 that fits best to their worst pain intensity over the past 24 hours, where 0 represents 'no pain at all' and 10 'the worst pain possible'.
Time Frame
Week 12
Title
Cohort 2: Change from Baseline in overall Quality of Life in Hand Eczema Questionnaire (QOLHEQ) score at each visit
Description
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 out 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.
Time Frame
Weeks 2, 4, 8, 12, 13
Title
Cohort 2: Percent Body Surface Area (BSA) affected by disease and percent change from baseline in BSA affected by disease
Description
The BSA affected by chronic hand eczema will be determined by the subject's hand method, where the subject's hand (including fingers) surface area is assumed to equal 1% of body surface area.
Time Frame
Weeks 2, 4, 8, 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Berk, MD
Organizational Affiliation
Arcutis Biotherapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Arcutis Clinical Site 239
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90212
Country
United States
Facility Name
Arcutis Clinical Site 225
City
Encino
State/Province
California
ZIP/Postal Code
91436
Country
United States
Facility Name
Arcutis Clinical Site 112
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
Arcutis Clinical Site 120
City
Irvine
State/Province
California
ZIP/Postal Code
92797
Country
United States
Facility Name
Arcutis Clinical Site 208
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Arcutis Clinical Site 174
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Arcutis Clinical Site 167
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Arcutis Clinical Site 104
City
Sanford
State/Province
Florida
ZIP/Postal Code
32771
Country
United States
Facility Name
Arcutis Clinical Site 214
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Facility Name
Arcutis Clinical Site 217
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
Facility Name
Arcutis Clinical Site 213
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Arcutis Clinical Site 125
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Arcutis Clinical Site 212
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Arcutis Clinical Site 216
City
New Brighton
State/Province
Minnesota
ZIP/Postal Code
55112
Country
United States
Facility Name
Arcutis Clinical Site 171
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Arcutis Clinical Site 115
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Arcutis Clinical Site 173
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Arcutis Clinical Site 135
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Arcutis Clinical Site 162
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
Arcutis Clinical Site 104
City
College Station
State/Province
Texas
ZIP/Postal Code
77845
Country
United States
Facility Name
Arcutis Clinical Site 164
City
Houston
State/Province
Texas
ZIP/Postal Code
77056
Country
United States
Facility Name
Arcutis Clinical Site 163
City
Pflugerville
State/Province
Texas
ZIP/Postal Code
78660
Country
United States
Facility Name
Arcutis Clinical Site 161
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78213
Country
United States
Facility Name
Arcutis Clinical Site 110
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78218
Country
United States
Facility Name
Arcutis Clinical Site 169
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Arcutis Clinical Site 306
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Arcutis Clinical Site 303
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Facility Name
Arcutis Clinical Site 207
City
Surrey
State/Province
British Columbia
Country
Canada
Facility Name
Arcutis Clinical Site 205
City
Ajax
State/Province
Ontario
Country
Canada
Facility Name
Arcutis Clinical Site 218
City
Barrie
State/Province
Ontario
Country
Canada
Facility Name
Arcutis Clinical Site 103
City
London
State/Province
Ontario
Country
Canada
Facility Name
Arcutis Clinical Site 133
City
Mississauga
State/Province
Ontario
Country
Canada
Facility Name
Arcutis Clinical Site 165
City
Oakville
State/Province
Ontario
Country
Canada
Facility Name
Arcutis Clinical Site 109
City
Peterborough
State/Province
Ontario
Country
Canada
Facility Name
Arcutis Clinical Site 241
City
Richmond Hill
State/Province
Ontario
Country
Canada
Facility Name
Arcutis Clinical Site 106
City
Waterloo
State/Province
Ontario
Country
Canada
Facility Name
Arcutis Clinical Site 242
City
Montreal
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Safety and Efficacy of ARQ-252 Cream in Subjects With Chronic Hand Eczema

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