The purpose of this study is to evaluate the efficacy and safety of ruxolitinib cream in adult participants with diagnosis of chronic hand eczema (CHE) and moderate to severe disease activity (Investigator's Global Assessement (IGA) of CHE score 3 or 4).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.
Vehicle cream is a topical formulation applied as a thin film to affected areas.
Percentage of Participants achieving Investigator's Global Assessment-Chronic Hand Eczema Treatment Success (IGA-CHE-TS)
The Investigator's Global Assessment for chronic hand eczema (IGA-CHE) is an instrument used in clinical trials to rate the severity of the participant's global chronic hand eczema (CHE) and is based on a 5-point scale ranging from 0 (clear) to 4 (severe). IGA-CHE treatment success (IGA-CHE TS) is defined as an IGA-CHE score of 0 (clear) or 1 (almost clear) with a ≥2-step improvement from baseline.
Time frame: Week 16
Percentage of Participants with a ≥ 4-point improvement in chronic hand eczema (CHE)-related Itch Numerical Rating Scale (NRS) score
The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity and subjects will rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable) on a daily basis.
Time frame: Baseline to Week 16
Percentage of Participants with a ≥ 2-point improvement in CHE-related Skin Pain NRS score
The Pain NRS is a validated, self-reported, instrument for measurement of itch intensity and subjects will rate the intensity of their pain on an 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable).
Time frame: Baseline to Week 16
Change from baseline in the mTLSS (modified Total Lesion Symptom Score
The mTLSS is a validated tool for assessing hand eczema. The scale quantifies the 7 features (erythema, scaling, hyperkeratosis/lichenification, vesiculation, oedema, fissures, and pruritus/pain) of HE (0 = none, 1 = mild, 2 = moderate, and 3 = severe).
Time frame: Up to Week 32
Percentage of Participants achieving an IGA CHE-TS
The Investigator's Global Assessment for chronic hand eczema (IGA-CHE) is an instrument used in clinical trials to rate the severity of the participant's global chronic hand eczema (CHE) and is based on a 5-point scale ranging from 0 (clear) to 4 (severe). IGA-CHE treatment success (IGA-CHE TS) is defined as an IGA-CHE score of 0 (clear) or 1 (almost clear) with a ≥2-step improvement from baseline.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of Alabama Hospital
Birmingham, Alabama, United States
Marvel Clinical Research LLC
Huntington Beach, California, United States
Advanced RX Clin Research
Westminster, California, United States
Advanced Rx Clinical Research
Westminster, California, United States
Forcare Clinical Research
Tampa, Florida, United States
Midwest Allergy Sinus Asthma, Sc
Springfield, Illinois, United States
The Indiana Clinical Trials Center Ictc
Plainfield, Indiana, United States
Delricht Research
Baton Rouge, Louisiana, United States
Jubilee
Las Vegas, Nevada, United States
Onsite Clinical Solutions, Llc Charlotte Central Office
Charlotte, North Carolina, United States
...and 29 more locations
Time frame: Up to Week 32
Change from baseline in CHE-related Itch NRS score (weekly average)
The Investigator's Global Assessment for chronic hand eczema (IGA-CHE) is an instrument used in clinical trials to rate the severity of the participant's global chronic hand eczema (CHE) and is based on a 5-point scale ranging from 0 (clear) to 4 (severe). IGA-CHE treatment success (IGA-CHE TS) is defined as an IGA-CHE score of 0 (clear) or 1 (almost clear) with a ≥2-step improvement from baseline.
Time frame: Up to Week 32
Change from baseline in CHE-related Skin Pain NRS score (weekly average)
The Pain NRS is a validated, self-reported, instrument for measurement of itch intensity and participants will rate the intensity of their pain on an 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable).
Time frame: Up to Week 32
Time to ≥ 4-point improvement in CHE-related Itch NRS score
The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity and participants will rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable) on a daily basis.
Time frame: Up to Week 32
Time to ≥ 2-point improvement in CHE-related Skin Pain NRS score
The Pain NRS is a validated, self-reported, instrument for measurement of itch intensity and participants will rate the intensity of their pain on an 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable) on a daily basis.
Time frame: Up to Week 32
Percentage change in Hand Eczema Severity Index (HECSI)
The Hand Eczema Severity Index (HECSI) is an instrument used in clinical trials to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) and the extent of the lesions in each of the 5 hand regions (fingertips, fingers \[except fingertips\], palm of hands, back of hands, and wrists) by use of standard scales.
Time frame: Baseline to Week 16
Percentage of participants with HECSI-75
HECSI is an instrument used in clinical trials to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) and the extent of the lesions in each of the 5 hand regions (fingertips, fingers \[except fingertips\], palm of hands, back of hands, and wrists) by use of standard scales.
Time frame: Weeks 2, 8, 16, 32
Percentage of participants with HECSI-90
HECSI is an instrument used in clinical trials to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) and the extent of the lesions in each of the 5 hand regions (fingertips, fingers \[except fingertips\], palm of hands, back of hands, and wrists) by use of standard scales.
Time frame: Weeks 2, 8, 16, 32
Mean Patient Global Impression of Change (PGIC) score
The Patient Global Impression of Change (PGIC) is a participants' self-reporting measure that reflects their belief about the efficacy of treatment. The PGIC is a 7-point scale depicting a participant's rating of overall improvement of CHE and will be captured during site visits. It is based on a 7-point scale and the participant will rate each question from the start of treatment as 1-very much improved, 2-much improved, 3-minimally improved, 4-no change, 5-minimally worse, 6-much worse, and 7-very much worse.
Time frame: Up to Week 32
Percentage of participants with each score on the PGIC
The PGIC is a participants' self-reporting measure that reflects their belief about the efficacy of treatment. The PGIC is a 7-point scale depicting a participant's rating of overall improvement of CHE and will be captured during site visits. It is based on a 7-point scale and the participant will rate each question from the start of treatment as 1-very much improved, 2-much improved, 3-minimally improved, 4-no change, 5-minimally worse, 6-much worse, and 7-very much worse.
Time frame: Up to Week 32
Percentage of participants with a score of either 1 or 2 on the PGIC
The PGIC is a participants' self-reporting measure that reflects their belief about the efficacy of treatment. The PGIC is a 7-point scale depicting a participant's rating of overall improvement of CHE and will be captured during site visits. It is based on a 7-point scale and the participant will rate each question from the start of treatment as 1-very much improved, 2-much improved, 3-minimally improved, 4-no change, 5-minimally worse, 6-much worse, and 7-very much worse.
Time frame: Up to Week 32
Change from baseline in Dermatology Life Quality Index (DLQI) score
The DLQI is a simple, 10 question (Q) validated quality-of-life questionnaire to measure how much the skin problem has affected the participant. It covers 6 domains including symptoms and feelings (Q1 and Q2), daily activities (Q3 and Q4), leisure (Q5 and Q6), work and school (Q7), personal relationships (Q8 and Q9), and treatment(Q10). The recall Period of this scale is over the last week. Response categories include 0-not at all, 1-a little, 2-a lot, and 3-very much, and unanswered or not relevant responses scored as 0. Scores range from 0 ("no impact on participant's life") to 30 ("extremely large effect on participant's life"), and a 4-point change from Baseline is considered as the minimal clinically important difference threshold. A negative change from Baseline indicates less impact of the skin problem on participant's life.
Time frame: Up to Week 32
Change from baseline in EQ-5D-5L score
EQ-5D-5L is a is a validated, self-administered, generic, utility questionnaire wherein participants will rate their current health state based on the following criteria: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Time frame: Up to Week 32
Change from baseline in Quality of Life in Hand Eczema Questionnaire (QOLHEQ) score
The QOLHEQ is a validated 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: Up to Week 32
Change from baseline in Working Limitations Questionnaire (WLQ) score
The Work Limitations Questionnaire (WLQ) is a patient self-rated scale designed to assess on the-job impact of chronic health problems and/or treatment. The WLQ consists of 25 items in 4 dimensions: limitations handling time (5 items), physical work demands (6 items), mental interpersonal work demands (9 items), and output demands (5 items). Each item is rated on a 5- point scale from "All of the Time" (score 5) to "None of the Time" (score 0), or "Does Not Apply to My Job". The WLQ Productivity Loss Score is derived from the Global Productivity Index, which is calculated as a weighed sum of the 4 dimensions. Reduction in WLQ Productivity Loss score indicates less work limitation and represents the estimated percentage of productivity loss in the past two weeks due to presenteeism relative to a healthy benchmark sample. WLQ Productivity Loss Score ranges from 0% to 24.9%. Higher percent productivity loss reflects more severe work limitations.
Time frame: Up to Week 32
Change from baseline in Work Productivity and Activity Impairment Questionnaire Specific Health Problem v2.0 in Chronic Hand Eczema (WPAI-SHP-CHE)
The WPAI:SHP questionnaire assesses both work productivity through absenteeism (i.e., work time missed), presenteeism (i.e., impairment at work or reduced on-the-job effectiveness), and work productivity loss, as well as daily activity impairment (e.g., work around the house, shopping, exercising, childcare, studying) attributable to excess weight. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Negative numbers indicate improvement from baseline.
Time frame: Up to week 32, followed by 30 days follow-up.
Number of Participants with Treatment Emergent Adverse Events (TEAE)
Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.
Time frame: Up to 40 weeks