This study is a multicentre, double-blinded, randomized, placebo-controlled, clinical trial with open-label extension. The purpose and aim of this study is to investigate the efficacy and safety of roflumilast (PDE4-inhibitor) in adult patients with chronic hand eczema (CHE). Patients will receive 16-week treatment with either roflumilast or placebo tablets. Hereafter, both groups continue in open-label treatment for 12 weeks where both groups will receive treatment with roflumilast.
This study will investigate the efficacy and safety of roflumilast in adult patients with CHE and it is hypothesized that patients treated with oral roflumilast (500 microgram once daily) will experience an improvement in their moderate-to-severe CHE (measured by hand eczema severity index (HECSI)) and alter the skin microbiome. Secondly, it is hypothesized that patients treated with oral roflumilast will experience improved lung function and weight loss. This study includes two phases: Phase 1: 20 patients will receive 500 microgram tablet of roflumilast once daily for 16 weeks while 20 patients will receive placebo once daily for 16 weeks. Phase 2: All 40 patients from phase 1 will receive 500 microgram tablet of roflumilast once daily for 12 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
40
Randomized to either systemic roflumilast or placebo in phase 1. All participating patients will receive roflumilast in phase 2.
Placebo tablets
Department of dermatology and veneorology, Bispebjerg Hospital
Copenhagen, Denmark
RECRUITINGProportion of patients achieving at least 75% reduction in hand eczema severity index (HECSI75) at week 16 when compared to HECSI at baseline.
HECSI is a measure of hand eczema disease severity considering the extent and intensity of the disease. Each hand is divided into five areas (fingertips, fingers (except the tips), palms, back of hands and wrists) and each area is graded on the intensity of six clinical signs: erythema, induration/papulation, vesicles, fissuring, scaling, and oedema. The grading scale used is: 0, no skin change; 1, mild disease; 2, moderate and 3, severe. The affected area for each location (total of both hands) are given a score from 0 to 4 (0, 0%; 1, 1-25%; 2, 26-50%; 3, 51-75% and 4, 76-100%) for the extent of clinical symptoms. Finally, the total sum of the intensity of the six clinical signs multiplied by the extent of each location is called HECSI score and it may vary from 0 to a maximum of 360 points, with higher scores reflecting greater disease severity. The score reflects HE severity as following: 1-16, mild HE; 17-37, moderate HE; 38-116 severe HE and 117-360, very severe HE.
Time frame: Through study completion, an average of 28 weeks
Proportion of patients achieving at least 50% reduction in baseline HECSI (HECSI50) at assessments.
HECSI is a measure of hand eczema disease severity considering the extent and intensity of the disease. Each hand is divided into five areas (fingertips, fingers (except the tips), palms, back of hands and wrists) and each area is graded on the intensity of six clinical signs: erythema, induration/papulation, vesicles, fissuring, scaling, and oedema. The grading scale used is: 0, no skin change; 1, mild disease; 2, moderate and 3, severe. The affected area for each location (total of both hands) are given a score from 0 to 4 (0, 0%; 1, 1-25%; 2, 26-50%; 3, 51-75% and 4, 76-100%) for the extent of clinical symptoms. Finally, the total sum of the intensity of the six clinical signs multiplied by the extent of each location is called HECSI score and it may vary from 0 to a maximum of 360 points, with higher scores reflecting greater disease severity. The score reflects HE severity as following: 1-16, mild HE; 17-37, moderate HE; 38-116 severe HE and 117-360, very severe HE.
Time frame: Through study completion, an average of 28 weeks
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Proportion of patients achieving at least 90% reduction in baseline HECSI (HECSI90) at assessments.
HECSI is a measure of hand eczema disease severity considering the extent and intensity of the disease. Each hand is divided into five areas (fingertips, fingers (except the tips), palms, back of hands and wrists) and each area is graded on the intensity of six clinical signs: erythema, induration/papulation, vesicles, fissuring, scaling, and oedema. The grading scale used is: 0, no skin change; 1, mild disease; 2, moderate and 3, severe. The affected area for each location (total of both hands) are given a score from 0 to 4 (0, 0%; 1, 1-25%; 2, 26-50%; 3, 51-75% and 4, 76-100%) for the extent of clinical symptoms. Finally, the total sum of the intensity of the six clinical signs multiplied by the extent of each location is called HECSI score and it may vary from 0 to a maximum of 360 points, with higher scores reflecting greater disease severity. The score reflects HE severity as following: 1-16, mild HE; 17-37, moderate HE; 38-116 severe HE and 117-360, very severe HE.
Time frame: Through study completion, an average of 28 weeks
Proportion of patients achieving at least 100% reduction in baseline HECSI (HECSI100) at assessments
HECSI is a measure of hand eczema disease severity considering the extent and intensity of the disease. Each hand is divided into five areas (fingertips, fingers (except the tips), palms, back of hands and wrists) and each area is graded on the intensity of six clinical signs: erythema, induration/papulation, vesicles, fissuring, scaling, and oedema. The grading scale used is: 0, no skin change; 1, mild disease; 2, moderate and 3, severe. The affected area for each location (total of both hands) are given a score from 0 to 4 (0, 0%; 1, 1-25%; 2, 26-50%; 3, 51-75% and 4, 76-100%) for the extent of clinical symptoms. Finally, the total sum of the intensity of the six clinical signs multiplied by the extent of each location is called HECSI score and it may vary from 0 to a maximum of 360 points, with higher scores reflecting greater disease severity. The score reflects HE severity as following: 1-16, mild HE; 17-37, moderate HE; 38-116 severe HE and 117-360, very severe HE.
Time frame: Through study completion, an average of 28 weeks
Percent change from baseline in HECSI score at assessments.
HECSI is a measure of hand eczema disease severity considering the extent and intensity of the disease. Each hand is divided into five areas (fingertips, fingers (except the tips), palms, back of hands and wrists) and each area is graded on the intensity of six clinical signs: erythema, induration/papulation, vesicles, fissuring, scaling, and oedema. The grading scale used is: 0, no skin change; 1, mild disease; 2, moderate and 3, severe. The affected area for each location (total of both hands) are given a score from 0 to 4 (0, 0%; 1, 1-25%; 2, 26-50%; 3, 51-75% and 4, 76-100%) for the extent of clinical symptoms. Finally, the total sum of the intensity of the six clinical signs multiplied by the extent of each location is called HECSI score and it may vary from 0 to a maximum of 360 points, with higher scores reflecting greater disease severity. The score reflects HE severity as following: 1-16, mild HE; 17-37, moderate HE; 38-116 severe HE and 117-360, very severe HE.
Time frame: Through study completion, an average of 28 weeks
Change (2 or more points) in physician global assessment for chronic hand eczema IGA-CHE) at assessments.
The IGA-CHE rates the severity of the patient's global disease assessed by the physician and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).
Time frame: Through study completion, an average of 28 weeks
Change from baseline in dermatology life quality index (DLQI) at assessments.
DLQI is a validated, self-administered, 10-item questionnaire that measure the impact of skin disease on patients' quality of life, based on recall over the past week. Domains include symptoms, feeling, daily activities, social, leisure, work or studying, personal relationships, and treatment. Each question is answered on a scale of 0 (not at all) to 3 (very much) and the total score may vary from 0 to 30.
Time frame: Through study completion, an average of 28 weeks
Change from baseline in patient's global assessment (PaGA) at assessments.
The PaGA rates the severity of the patient's global disease assessed by the patient and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).
Time frame: Through study completion, an average of 28 weeks
Change from baseline in numeric rating scale (NRS) - Peak skin pain on hands within the last 24 hours at assessments.
NRS is a simple and commonly used numeric scale in which the patient rates patient symptoms such as pain, itch and sleeplessness on a scale from 0 (no pain, no itch, no sleeplessness) to 10 (worst pain, worst itch, worst sleeplessness).
Time frame: Through study completion, an average of 28 weeks
Change from baseline in numeric rating scale (NRS) - Peak skin pain on hands within the last 7 days at assessments.
NRS is a simple and commonly used numeric scale in which the patient rates patient symptoms such as pain, itch and sleeplessness on a scale from 0 (no pain, no itch, no sleeplessness) to 10 (worst pain, worst itch, worst sleeplessness).
Time frame: Through study completion, an average of 28 weeks
Change from baseline in NRS - Peak itch on hands within the last 24 hours at assessments.
NRS is a simple and commonly used numeric scale in which the patient rates patient symptoms such as pain, itch and sleeplessness on a scale from 0 (no pain, no itch, no sleeplessness) to 10 (worst pain, worst itch, worst sleeplessness).
Time frame: Through study completion, an average of 28 weeks
Change from baseline in NRS - Peak itch on hands within the last 7 days at assessments.
NRS is a simple and commonly used numeric scale in which the patient rates patient symptoms such as pain, itch and sleeplessness on a scale from 0 (no pain, no itch, no sleeplessness) to 10 (worst pain, worst itch, worst sleeplessness).
Time frame: Through study completion, an average of 28 weeks
Change from baseline in NRS - sleeplessness within the last 24 hours at assessments.
NRS is a simple and commonly used numeric scale in which the patient rates patient symptoms such as pain, itch and sleeplessness on a scale from 0 (no pain, no itch, no sleeplessness) to 10 (worst pain, worst itch, worst sleeplessness).
Time frame: Through study completion, an average of 28 weeks
Change from baseline in NRS - sleeplessness within the last 7 at assessments.
NRS is a simple and commonly used numeric scale in which the patient rates patient symptoms such as pain, itch and sleeplessness on a scale from 0 (no pain, no itch, no sleeplessness) to 10 (worst pain, worst itch, worst sleeplessness).
Time frame: Through study completion, an average of 28 weeks
Change from baseline in NRS - Patient treatment satisfaction within the last 7 at assessments.
NRS is a simple and commonly used numeric scale in which the patient rates patient treatment satisfaction on a scale from 0 (very unsatisfied) to 10 (very satisfied).
Time frame: Through study completion, an average of 28 weeks
Change from baseline in quality of life hand eczema questionnaire (QOLHEQ) at assessments.
QOLHEQ is a validated, self-administered 30-question questionnaire that measures impairment of health-related quality of life (HRQoL) in patients with HE. Domains include symptoms, emotions, functioning and treatment/prevention. 0 (not at all) to 4 (all the time) and the total score may vary from 0 to 120. A QOLHEQ score greater than 86 is indicative of very strong impairment.
Time frame: Through study completion, an average of 28 weeks
Change from baseline in work productivity and activity impairment: CHE (WPAI:CHE) at assessments.
WPAI is a validated, self-administered questionnaire that measures the impact of CHE on work. Domains include time missed from work and impairment of work and regular activities due to CHE.
Time frame: Through study completion, an average of 28 weeks
Adverse events (AEs), serious adverse events (SAEs), serious adverse reactions (SARs), and suspected unexpected serious adverse reactions (SUSARS) documented at assessments.
AE are any unfavorable and/or unintended sign or incident, symptoms or disease, whether related to roflumilast or placebo. This also includes laboratory results outside the reference range, though only laboratory results with clinical relevance will be examined. Any AE from the first administration of the trial medication to 8 days after the last administration of the trial medicine will be recorded, though unfavorable event reported in questionnaires will not be recorded as AE. SAE and SAR are any AE or adverse reaction that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, or is a congenital anomaly of birth defect.
Time frame: Through study completion, an average of 28 weeks