The purpose of this study is to investigate the efficacy of dupilumab in hand eczema patients with an inadequate response or intolerance to alitretinoin.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
30
University Medical Center Groningen
Groningen, Netherlands
Response to treatment/hand eczema severity (Hand Eczema Severity Index, HECSI)
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). A decrease in score relates to an improvement in signs and symptoms. Response is defined as HECSI-75: the proportion of patients wit a HECSI score of ≥75% improvement from baseline.
Time frame: 16 weeks
Response to treatment/hand eczema severity (Photographic guide)
The photographic guide is a five-point scale that provides a global clinical assessment of hand eczema severity ranging from 0 to 4, where 0 indicates clear, 1 is almost clear, 2 is moderate, 4 is severe; and 5 indicates very severe hand eczema. A decrease in score relates to an improvement in signs and symptoms.
Time frame: Week 4, 8, 12, 16
Response to treatment/hand eczema/foot eczema severity (Physician Global Assessment)
A decrease in score relates to an improvement in signs and symptoms.
Time frame: Week 4, 8, 12, 16
Response to treatment/hand eczema/foot eczema severity (modified Total Lesion Symptom Score, mTLSS)
mTLSS combines an evaluation of hand and foot eczema lesions severity; scores are summed, extending from a base estimation of 0 (no signs or symptoms) to the most extreme of 18 (more serious disease).
Time frame: Week 4, 8, 12, 16
Response to treatment/hand eczema severity (Hand Eczema Severity Index, HECSI)
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). A decrease in score relates to an improvement in signs and symptoms.
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Time frame: Week 4, 8, 12, 16
Patient reported change (Patient Global Assessment, PaGA)
Percentage of change of hand eczema symptoms assessed by PaGA. 0 indicates clear or almost clear (at least 90% clearing of disease signs and symptoms compared to baseline), 5 means worsening of symptoms compared to baseline.
Time frame: Week 4, 8, 12, 16
Changeof pruritus (Numerical Rating Scale, NRS)
Pruritus NRS is an assessment tool that is used to report the intensity of a patient's pruritus, both maximum and average intensity, during a 24-hour recall period. Maximum itch intensity on a scale of 0 - 10 (0 = no itch; 10 = worst itch imaginable).
Time frame: Week 4, 8, 12, 16
Change of pain (Numerical Rating Scale, NRS)
Pain NRS is an assessment tool that is used to report the intensity of a patient's pain, both maximum and average intensity, during a 24-hour recall period. Maximum pain intensity on a scale of 0 - 10 (0 = no pain; 10 = worst pain imaginable).
Time frame: Week 4, 8, 12, 16
Change of hand eczema related quality of life (Quality of Life in Hand Eczema Questionnaire, QOLHEQ)
The Quality Of Life in Hand Eczema Questionnaire (QOLHEQ) is an instrument to assess disease specific Health Related Quality of Life (HRQOL) in patients suffering from hand eczema. The construct HRQOL includes all impairments or limiting conditions caused by the health state of an individual. 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. A high score is indicative of a poor hand eczema related HRQOL.
Time frame: Week 4, 8, 12, 16
Changeof quality of life (Dermatology Life Quality Index, DLQI)
DLQI is a 10-item, validated questionnaire to assess the impact of skin disease symptoms and treatment on quality of life (QOL); over the past week, with an overall scoring of 0 (disease has no effect on patient's life) to 30 (disease has an extremely large effect on patient's life); a high score is indicative of a poor QoL.
Time frame: Week 4, 8, 12, 16
Change of work productivity and impairment (Work Productivity and Activity Impairment, WPAI)
The WPAI consists of 6 items, assessing absenteeism, presenteeism, work productivity loss and activity impairment. Higher scores indicate less productivity and a greater impairment.
Time frame: Week 4, 8, 12, 16
Change of anxiety and depression (Hospital Anxiety and Depression scale, HADS)
HADS is a 14-item questionnaire, 7 items for anxiety and 7 items for depression symptoms; possible scores range from 0 to 21 for each subscale. The following cut-off scores are recommended for both subscales: 7 to 8 for possible presence, 10 to 11 for probable presence, and 14 to 15 for severe anxiety or depression.
Time frame: Week 4, 8, 12, 16
Cost-utility. Quality-adjusted life-years (QALY's): registered direct/indirect costs, combined with EQ-5D-5L outcome
Time frame: Week 4, 8, 12, 16
Cost-effectiveness: registered direct/indirect costs combined with the primary and secondary effectiveness outcomes (HECSI and PG)
Time frame: Week 4, 8, 12, 16
Safety and tolerability (adverse events)
Time frame: Up to 16 weeks