April 29, 2021
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May 4, 2021
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January 9, 2023
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May 25, 2021
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December 27, 2022 (Final data collection date for primary outcome measure)
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IGA-CHE TS at Week 16 [ Time Frame: 16 weeks ] 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.
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Same as current
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- Reduction of HESD itch score (weekly average) of ≥4 points from baseline at Week 16 [ Time Frame: 16 weeks ]
The Hand Eczema Symptom Diary (HESD) is an eDiary in which participants will assess the worst severity of 6 individual signs and symptoms of CHE over the past 24 hours using an 11-point numeric rating scale throughout the trial on a daily basis. This endpoint will only assess the 'itch' component and will be evaluated among participants with a baseline HESD itch score (weekly average) ≥4 points.
- Reduction of HESD score (weekly average) of ≥4 points from baseline at Week 16 [ Time Frame: 16 weeks ]
The Hand Eczema Symptom Diary (HESD) is an eDiary in which participants will assess the worst severity of 6 individual signs and symptoms of CHE over the past 24 hours using an 11-point numeric rating scale throughout the trial on a daily basis. The HESD score is derived as the average of the 6 signs and symptoms. This endpoint will be evaluated among participants with a baseline HESD score (weekly average) ≥4 points.
- IGA-CHE TS at Week 8 [ Time Frame: 8 weeks ]
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 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.
- IGA-CHE TS at Week 4 [ Time Frame: 4 weeks ]
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 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.
- Reduction of HESD itch score (weekly average) of ≥4 points from baseline at Week 8 [ Time Frame: 8 weeks ]
The Hand Eczema Symptom Diary (HESD) is an eDiary in which participants will assess the worst severity of 6 individual signs and symptoms of CHE over the past 24 hours using an 11-point numeric rating scale throughout the trial on a daily basis. This endpoint will only assess the 'itch' component and will be evaluated among participants with a baseline HESD itch score (weekly average) ≥4 points.
- Reduction of HESD itch score (weekly average) of ≥4 points from baseline at Week 4 [ Time Frame: 4 weeks ]
The Hand Eczema Symptom Diary (HESD) is an eDiary in which participants will assess the worst severity of 6 individual signs and symptoms of CHE over the past 24 hours using an 11-point numeric rating scale throughout the trial on a daily basis. This endpoint will only assess the 'itch' component and will be evaluated among participants with a baseline HESD itch score (weekly average) ≥4 points.
- Reduction of HESD itch score (weekly average) of ≥4 points from baseline at Week 2 [ Time Frame: 2 weeks ]
The Hand Eczema Symptom Diary (HESD) is an eDiary in which participants will assess the worst severity of 6 individual signs and symptoms of CHE over the past 24 hours using an 11-point numeric rating scale throughout the trial on a daily basis. This endpoint will only assess the 'itch' component and will be evaluated among participants with a baseline HESD itch score (weekly average) ≥4 points.
- Reduction of HESD score (weekly average) of ≥4 points from baseline at Week 8 [ Time Frame: 8 weeks ]
The Hand Eczema Symptom Diary (HESD) is an eDiary in which participants will assess the worst severity of 6 individual signs and symptoms of CHE over the past 24 hours using an 11-point numeric rating scale throughout the trial on a daily basis. The HESD score is derived as the average of the 6 signs and symptoms. This endpoint will be evaluated among participants with a baseline HESD score (weekly average) ≥4 points.
- Reduction of HESD score (weekly average) of ≥4 points from baseline at Week 4 [ Time Frame: 4 weeks ]
The Hand Eczema Symptom Diary (HESD) is an eDiary in which participants will assess the worst severity of 6 individual signs and symptoms of CHE over the past 24 hours using an 11-point numeric rating scale throughout the trial on a daily basis. The HESD score is derived as the average of the 6 signs and symptoms. This endpoint will be evaluated among participants with a baseline HESD score (weekly average) ≥4 points.
- Reduction of HESD pain score (weekly average) of ≥4 points from baseline at Week 16 [ Time Frame: 16 weeks ]
The Hand Eczema Symptom Diary (HESD) is an eDiary in which participants will assess the worst severity of 6 individual signs and symptoms of CHE over the past 24 hours using an 11-point numeric rating scale throughout the trial on a daily basis. This endpoint will only assess the 'pain' component and will be evaluated among participants with a baseline HESD pain score (weekly average) ≥4 points.
- Reduction of HESD pain score (weekly average) of ≥4 points from baseline at Week 8 [ Time Frame: 8 weeks ]
The Hand Eczema Symptom Diary (HESD) is an eDiary in which participants will assess the worst severity of 6 individual signs and symptoms of CHE over the past 24 hours using an 11-point numeric rating scale throughout the trial on a daily basis. This endpoint will only assess the 'pain' component and will be evaluated among participants with a baseline HESD pain score (weekly average) ≥4 points.
- Reduction of HESD pain score (weekly average) of ≥4 points from baseline at Week 4 [ Time Frame: 4 weeks ]
The Hand Eczema Symptom Diary (HESD) is an eDiary in which participants will assess the worst severity of 6 individual signs and symptoms of CHE over the past 24 hours using an 11-point numeric rating scale throughout the trial on a daily basis. This endpoint will only assess the 'pain' component and will be evaluated among participants with a baseline HESD pain score (weekly average) ≥4 points.
- HECSI-90 at Week 16 [ Time Frame: 16 weeks ]
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. The HECSI score will range from 0 (lowest possible score) to 360 (highest possible score). HECSI-90 is defined as at least 90% improvement in HECSI score from baseline.
- HECSI-75 at Week 16 [ Time Frame: 16 weeks ]
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. The HECSI score will range from 0 (lowest possible score) to 360 (highest possible score). HECSI-75 is defined as at least 75% improvement in HECSI score from baseline.
- HECSI-75 at Week 8 [ Time Frame: 8 weeks ]
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. The HECSI score will range from 0 (lowest possible score) to 360 (highest possible score). HECSI-75 is defined as at least 75% improvement in HECSI score from baseline.
- Percentage change in HECSI score from baseline to Week 16 [ Time Frame: 16 weeks ]
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. The HECSI score will range from 0 (lowest possible score) to 360 (highest possible score).
- Change in DLQI score from baseline to Week 16 [ Time Frame: 16 weeks ]
The Dermatology Life Quality Index (DLQI) is a validated questionnaire consisting of 10 items addressing the participant's perception of the impact of their skin disease on different aspects of their quality of life over the last week. The DLQI score is the sum of the 10 items (score ranging from 0 to 30).
- Change in HESD score (weekly average) from baseline to Week 16 [ Time Frame: 16 weeks ]
The Hand Eczema Symptom Diary (HESD) is an eDiary in which participants will assess the worst severity of 6 individual signs and symptoms of CHE over the past 24 hours using an 11-point numeric rating scale throughout the trial on a daily basis. The HESD score is derived as the average of the 6 signs and symptoms.
- Change in HESD itch score (weekly average) from baseline to Week 16 [ Time Frame: 16 weeks ]
The Hand Eczema Symptom Diary (HESD) is an eDiary in which participants will assess the worst severity of 6 individual signs and symptoms of CHE over the past 24 hours using an 11-point numeric rating scale throughout the trial on a daily basis. This endpoint will only assess the 'itch' component.
- Change in HESD pain score (weekly average) from baseline to Week 16 [ Time Frame: 16 weeks ]
The Hand Eczema Symptom Diary (HESD) is an eDiary in which participants will assess the worst severity of 6 individual signs and symptoms of CHE over the past 24 hours using an 11-point numeric rating scale throughout the trial on a daily basis. This endpoint will only assess the 'pain' component.
- Change in HEIS score from baseline to Week 16 [ Time Frame: 16 weeks ]
The Hand Eczema Impact Scale (HEIS) addresses 9 items within the following domains: Proximal Daily Activity Limitations (PDAL), embarrassment with the appearance of the hands, frustration with CHE, sleep, work, and physical functioning. Each item is scored on a 5-point scale ranging from 0 (not at all) to 4 (extremely). The HEIS score is the average of the 9 items.
- Change in HEIS PDAL score from baseline to Week 16 [ Time Frame: 16 weeks ]
Proximal Daily Activity Limitations (PDAL) is one of the items addressed in the Hand Eczema Impact Scale (HEIS) and is scored on a 5-point scale ranging from 0 (not at all) to 4 (extremely).
- Reduction of DLQI score of ≥4 points from baseline at Week 16 [ Time Frame: 16 weeks ]
The Dermatology Life Quality Index (DLQI) is a validated questionnaire consisting of 10 items addressing the participant's perception of the impact of their skin disease on different aspects of their quality of life over the last week. The DLQI score is the sum of the 10 items (score ranging from 0 to 30). This endpoint will be evaluated among participants with a baseline DLQI score ≥4 points.
- Number of treatment-emergent AEs from baseline up to end of trial per participant [ Time Frame: 16 weeks (18 weeks for participants not participating in the long-term extension trial [LP0133-1403]) ]
An adverse event (AE) will be considered treatment emergent if started after the first application of investigational medicinal product (IMP), or if started before the first application of IMP and worsened in severity after first dose of IMP. End of trial is defined as Week 16 for participants who roll over to the long-term extension trial and as Week 18 for participants who do not roll over.
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- Reduction of HESD itch score (weekly average) of ≥4 points from baseline at Week 16 [ Time Frame: 16 weeks ]
The Hand Eczema Symptom Diary (HESD) is an eDiary in which participants will assess the worst severity of 6 individual signs and symptoms of CHE over the past 24 hours using an 11-point numeric rating scale throughout the trial on a daily basis. This endpoint will only assess the 'itch' component and will be evaluated among participants with a baseline HESD itch score (weekly average) ≥4 points.
- Reduction of HESD score (weekly average) of ≥4 points from baseline at Week 16 [ Time Frame: 16 weeks ]
The Hand Eczema Symptom Diary (HESD) is an eDiary in which participants will assess the worst severity of 6 individual signs and symptoms of CHE over the past 24 hours using an 11-point numeric rating scale throughout the trial on a daily basis. The HESD score is derived as the average of the 6 signs and symptoms. This endpoint will be evaluated among participants with a baseline HESD score (weekly average) ≥4 points.
- IGA-CHE TS at Week 8 [ Time Frame: 8 weeks ]
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 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.
- IGA-CHE TS at Week 4 [ Time Frame: 4 weeks ]
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 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.
- Reduction of HESD itch score (weekly average) of ≥4 points from baseline at Week 8 [ Time Frame: 8 weeks ]
The Hand Eczema Symptom Diary (HESD) is an eDiary in which participants will assess the worst severity of 6 individual signs and symptoms of CHE over the past 24 hours using an 11-point numeric rating scale throughout the trial on a daily basis. This endpoint will only assess the 'itch' component and will be evaluated among participants with a baseline HESD itch score (weekly average) ≥4 points.
- Reduction of HESD itch score (weekly average) of ≥4 points from baseline at Week 4 [ Time Frame: 4 weeks ]
The Hand Eczema Symptom Diary (HESD) is an eDiary in which participants will assess the worst severity of 6 individual signs and symptoms of CHE over the past 24 hours using an 11-point numeric rating scale throughout the trial on a daily basis. This endpoint will only assess the 'itch' component and will be evaluated among participants with a baseline HESD itch score (weekly average) ≥4 points.
- Reduction of HESD itch score (weekly average) of ≥4 points from baseline at Week 2 [ Time Frame: 2 weeks ]
The Hand Eczema Symptom Diary (HESD) is an eDiary in which participants will assess the worst severity of 6 individual signs and symptoms of CHE over the past 24 hours using an 11-point numeric rating scale throughout the trial on a daily basis. This endpoint will only assess the 'itch' component and will be evaluated among participants with a baseline HESD itch score (weekly average) ≥4 points.
- Reduction of HESD score (weekly average) of ≥4 points from baseline at Week 8 [ Time Frame: 8 weeks ]
The Hand Eczema Symptom Diary (HESD) is an eDiary in which participants will assess the worst severity of 6 individual signs and symptoms of CHE over the past 24 hours using an 11-point numeric rating scale throughout the trial on a daily basis. The HESD score is derived as the average of the 6 signs and symptoms. This endpoint will be evaluated among participants with a baseline HESD score (weekly average) ≥4 points.
- Reduction of HESD score (weekly average) of ≥4 points from baseline at Week 4 [ Time Frame: 4 weeks ]
The Hand Eczema Symptom Diary (HESD) is an eDiary in which participants will assess the worst severity of 6 individual signs and symptoms of CHE over the past 24 hours using an 11-point numeric rating scale throughout the trial on a daily basis. The HESD score is derived as the average of the 6 signs and symptoms. This endpoint will be evaluated among participants with a baseline HESD score (weekly average) ≥4 points.
- Reduction of HESD pain score (weekly average) of ≥4 points from baseline at Week 16 [ Time Frame: 16 weeks ]
The Hand Eczema Symptom Diary (HESD) is an eDiary in which participants will assess the worst severity of 6 individual signs and symptoms of CHE over the past 24 hours using an 11-point numeric rating scale throughout the trial on a daily basis. This endpoint will only assess the 'pain' component and will be evaluated among participants with a baseline HESD pain score (weekly average) ≥4 points.
- Reduction of HESD pain score (weekly average) of ≥4 points from baseline at Week 8 [ Time Frame: 8 weeks ]
The Hand Eczema Symptom Diary (HESD) is an eDiary in which participants will assess the worst severity of 6 individual signs and symptoms of CHE over the past 24 hours using an 11-point numeric rating scale throughout the trial on a daily basis. This endpoint will only assess the 'pain' component and will be evaluated among participants with a baseline HESD pain score (weekly average) ≥4 points.
- Reduction of HESD pain score (weekly average) of ≥4 points from baseline at Week 4 [ Time Frame: 4 weeks ]
The Hand Eczema Symptom Diary (HESD) is an eDiary in which participants will assess the worst severity of 6 individual signs and symptoms of CHE over the past 24 hours using an 11-point numeric rating scale throughout the trial on a daily basis. This endpoint will only assess the 'pain' component and will be evaluated among participants with a baseline HESD pain score (weekly average) ≥4 points.
- HECSI-90 at Week 16 [ Time Frame: 16 weeks ]
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. The HECSI score will range from 0 (lowest possible score) to 360 (highest possible score). HECSI-90 is defined as at least 90% improvement in HECSI score from baseline.
- HECSI-75 at Week 16 [ Time Frame: 16 weeks ]
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. The HECSI score will range from 0 (lowest possible score) to 360 (highest possible score). HECSI-75 is defined as at least 75% improvement in HECSI score from baseline.
- HECSI-75 at Week 8 [ Time Frame: 8 weeks ]
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. The HECSI score will range from 0 (lowest possible score) to 360 (highest possible score). HECSI-75 is defined as at least 75% improvement in HECSI score from baseline.
- Percentage change in HECSI score from baseline to Week 16 [ Time Frame: 16 weeks ]
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. The HECSI score will range from 0 (lowest possible score) to 360 (highest possible score).
- Change in DLQI score from baseline to Week 16 [ Time Frame: 16 weeks ]
The Dermatology Life Quality Index (DLQI) is a validated questionnaire consisting of 10 items addressing the participant's perception of the impact of their skin disease on different aspects of their quality of life over the last week. The DLQI score is the sum of the 10 items (score ranging from 0 to 30).
- Change in HESD score (weekly average) from baseline to Week 16 [ Time Frame: 16 weeks ]
The Hand Eczema Symptom Diary (HESD) is an eDiary in which participants will assess the worst severity of 6 individual signs and symptoms of CHE over the past 24 hours using an 11-point numeric rating scale throughout the trial on a daily basis. The HESD score is derived as the average of the 6 signs and symptoms.
- Change in HESD itch score (weekly average) from baseline to Week 16 [ Time Frame: 16 weeks ]
The Hand Eczema Symptom Diary (HESD) is an eDiary in which participants will assess the worst severity of 6 individual signs and symptoms of CHE over the past 24 hours using an 11-point numeric rating scale throughout the trial on a daily basis. This endpoint will only assess the 'itch' component.
- Change in HESD pain score (weekly average) from baseline to Week 16 [ Time Frame: 16 weeks ]
The Hand Eczema Symptom Diary (HESD) is an eDiary in which participants will assess the worst severity of 6 individual signs and symptoms of CHE over the past 24 hours using an 11-point numeric rating scale throughout the trial on a daily basis. This endpoint will only assess the 'pain' component.
- Change in HEIS score from baseline to Week 16 [ Time Frame: 16 weeks ]
The Hand Eczema Impact Scale (HEIS) addresses 9 items within the following domains: Proximal Daily Activity Limitations (PDAL), embarrassment with the appearance of the hands, frustration with CHE, sleep, work, and physical functioning. Each item is scored on a 5-point scale ranging from 0 (not at all) to 4 (extremely). The HEIS score is the average of the 9 items.
- Change in HEIS PDAL score from baseline to Week 16 [ Time Frame: 16 weeks ]
Proximal Daily Activity Limitations (PDAL) is one of the items addressed in the Hand Eczema Impact Scale (HEIS) and is scored on a 5-point scale ranging from 0 (not at all) to 4 (extremely).
- Reduction of DLQI score of ≥4 points from baseline at Week 16 [ Time Frame: 16 weeks ]
The Dermatology Life Quality Index (DLQI) is a validated questionnaire consisting of 10 items addressing the participant's perception of the impact of their skin disease on different aspects of their quality of life over the last week. The DLQI score is the sum of the 10 items (score ranging from 0 to 30). This endpoint will be evaluated among participants with a baseline DLQI score ≥4 points.
- PaGA TS at Week 16 [ Time Frame: 16 weeks ]
The Patient's Global Assessment of disease severity (PaGA) is a participant global assessment of the severity of CHE based on a 5-point scale ranging from 0 (clear) to 4 (severe). PaGA treatment success (PaGA TS) is defined as a PaGA score of 0 (clear) or 1 (almost clear) with a ≥2-step improvement from baseline.
- Number of treatment-emergent AEs from baseline up to end of trial per participant [ Time Frame: 16 weeks (18 weeks for participants not participating in the long-term extension trial [LP0133-1403]) ]
An adverse event (AE) will be considered treatment emergent if started after the first application of investigational medicinal product (IMP), or if started before the first application of IMP and worsened in severity after first dose of IMP. End of trial is defined as Week 16 for participants who roll over to the long-term extension trial and as Week 18 for participants who do not roll over.
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Not Provided
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Not Provided
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Efficacy and Safety of Delgocitinib Cream in Adults With Moderate to Severe Chronic Hand Eczema (DELTA 2)
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A Phase 3 Clinical Trial to Confirm Efficacy and Evaluate Safety of Twice-daily Delgocitinib Cream 20 mg/g Compared With Cream Vehicle for a 16-week Treatment Period in Adult Subjects With Moderate to Severe Chronic Hand Eczema (DELTA 2)
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This is a 16-week study in adult participants with chronic hand eczema (CHE). The participants will visit the clinic regularly to have the study doctor assess their CHE and to answer questions about itch, pain, CHE symptoms, and quality of life.
The purpose is to assess how delgocitinib cream works to treat CHE when compared to a placebo cream with no active substance.
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Not Provided
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Interventional
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Phase 3
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Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment
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Chronic Hand Eczema
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- Drug: Delgocitinib cream
Cream for topical application
Other Name: LEO 124249 cream
- Drug: Cream vehicle
The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.
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- Experimental: Delgocitinib 20 mg/g
Twice-daily topical application for 16 weeks
Intervention: Drug: Delgocitinib cream
- Placebo Comparator: Cream vehicle
Twice-daily topical application for 16 weeks
Intervention: Drug: Cream vehicle
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Not Provided
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Completed
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473
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450
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January 6, 2023
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December 27, 2022 (Final data collection date for primary outcome measure)
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Main inclusion criteria:
- Diagnosis of CHE, defined as hand eczema that has persisted for more than 3 months or returned twice or more within the last 12 months.
- Disease severity graded as moderate to severe at screening and baseline according to IGA-CHE (i.e. an IGA-CHE score of 3 or 4).
- HESD itch score (weekly average) of ≥4 points at baseline.
- Participants who have a documented recent history of inadequate response to treatment with topical corticosteroids (TCS) or for whom TCS are documented to be otherwise medically inadvisable (e.g. due to important side effects or safety risks).
- Participants adherent to standard non-medicated skin care including avoidance of known and relevant irritants and allergens.
Main exclusion criteria:
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Sexes Eligible for Study: |
All |
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18 Years and older (Adult, Older Adult)
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No
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Contact information is only displayed when the study is recruiting subjects
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Belgium, Canada, Denmark, Germany, Netherlands, Poland, Spain
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NCT04872101
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LP0133-1402 2020-002961-32 ( EudraCT Number )
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No
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Studies a U.S. FDA-regulated Drug Product: |
No |
Studies a U.S. FDA-regulated Device Product: |
No |
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Plan to Share IPD: |
Yes |
Plan Description: |
De-identified IPD can be made available to researchers in a closed environment for a specified period of time. |
Supporting Materials: |
Study Protocol |
Supporting Materials: |
Statistical Analysis Plan (SAP) |
Supporting Materials: |
Clinical Study Report (CSR) |
Time Frame: |
Data is available to request after results of the trial are available on leopharmatrials.com |
Access Criteria: |
Data-sharing is subject to approved scientifically sound research proposal and signed data-sharing agreement. |
URL: |
http://leopharmatrials.com/for-professionals |
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LEO Pharma
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Same as current
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LEO Pharma
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Same as current
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Not Provided
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Study Director: |
Medical Expert |
LEO Pharma |
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LEO Pharma
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January 2023
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