Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
50% reduction in number of lesion |
proportion of subjects who achieve at least a 50% reduction in total number of inflammatory lesions |
24 weeks |
|
Secondary |
Proportionof subjects in Investigator global assessment (IGA) |
proportion of subjects who achieve an IGA 0 / 1 or an improvement of a minimum 2 points on an IGA 5-point scale (value 0 to 4, whereby 0 is symptom-free and 4 severe symptoms) |
Baseline to visit 3 (week 2) |
|
Secondary |
proportion of subjects in Investigator global assessment (IGA) |
proportion of subjects who achieve an IGA 0 / 1 or an improvement of a minimum 2 points on an IGA 5-point scale (value 0 to 4, whereby 0 is symptom-free and 4 severe symptoms) |
Baseline to visit 4 (week 4) |
|
Secondary |
proportion of subjects in Investigator global assessment (IGA) |
proportion of subjects who achieve an IGA 0 / 1 or an improvement of a minimum 2 points on an IGA 5-point scale (value 0 to 4, whereby 0 is symptom-free and 4 severe symptoms) |
Baseline to visit 5 (week 8) |
|
Secondary |
proportion of subjects in Investigator global assessment (IGA) |
proportion of subjects who achieve an IGA 0 / 1 or an improvement of a minimum 2 points on an IGA 5-point scale (value 0 to 4, whereby 0 is symptom-free and 4 severe symptoms) |
Baseline to visit 6 (week 16) |
|
Secondary |
proportion of subjects in Investigator global assessment (IGA) |
proportion of subjects who achieve an IGA 0 / 1 or an improvement of a minimum 2 points on an IGA 5-point scale (value 0 to 4, whereby 0 is symptom-free and 4 severe symptoms) |
Baseline to visit 7 (week 24) |
|
Secondary |
change in skin condition |
skin condition measured in Symptoms Score REduction Index (SSRI), calculated as the percentage of lesions after treatment in relation to before treatment. The lower the value the more reduction of lesions was achieved by treatment |
at visit 3 (week 2) |
|
Secondary |
change in skin condition |
skin condition measured in Symptoms Score REduction Index (SSRI)calculated as the percentage of lesions after treatment in relation to before treatment. The lower the value the more reduction of lesions was achieved by treatment |
at visit 4 (week 4) |
|
Secondary |
change in skin condition |
skin condition measured in Symptoms Score Reduction Index (SSRI)calculated as the percentage of lesions after treatment in relation to before treatment. The lower the value the more reduction of lesions was achieved by treatment |
at visit 5 (week 8) |
|
Secondary |
change in skin condition |
skin condition measured in Symptoms Score Reduction Index (SSRI)calculated as the percentage of lesions after treatment in relation to before treatment. The lower the value the more reduction of lesions was achieved by treatment |
at visit 6 (week 16) |
|
Secondary |
change in skin condition |
skin condition measured in Symptoms Score Reduction Index (SSRI)calculated as the percentage of lesions after treatment in relation to before treatment. The lower the value the more reduction of lesions was achieved by treatment |
at visit 7 (week 24) |
|
Secondary |
change in pain of the inflammatory lesions |
pain of the inflammatory lesions measured by a visual analog scale (VAS), measured in mm values (0 mm to 100 mm). The higher the value the more pain is experienced by the subject. |
at visit 3 (week 2) |
|
Secondary |
change in pain of the inflammatory lesions |
pain of the inflammatory lesions measured by a visual analog scale (VAS)measured in mm values (0 mm to 100 mm). The higher the value the more pain is experienced by the subject. |
at visit 4 (week 4) |
|
Secondary |
change in pain of the inflammatory lesions |
pain of the inflammatory lesions measured by a visual analog scale (VAS)measured in mm values (0 mm to 100 mm). The higher the value the more pain is experienced by the subject. |
at visit 5 (week 8) |
|
Secondary |
change in pain of the inflammatory lesions |
pain of the inflammatory lesions measured by a visual analog scale (VAS)measured in mm values (0 mm to 100 mm). The higher the value the more pain is experienced by the subject. |
at visit 6 (week 16) |
|
Secondary |
change in pain of the inflammatory lesions |
pain of the inflammatory lesions measured by a visual analog scale (VAS)measured in mm values (0 mm to 100 mm). The higher the value the more pain is experienced by the subject. |
at visit 7 (week 24) |
|
Secondary |
change in itch of the inflammatory lesions measured by a VAS |
itch of the inflammatory lesions measured by a VAS, measured in mm values (0 mm to 100 mm). The higher the value the more itching is experienced by the subject. |
at visit 3 (week 2) |
|
Secondary |
change in itch of the inflammatory lesions measured by a VAS |
itch of the inflammatory lesions measured by a VAS, measured in mm values (0 mm to 100 mm). The higher the value the more itching is experienced by the subject. |
at visit 4 (week 4) |
|
Secondary |
change in itch of the inflammatory lesions measured by a VAS |
itch of the inflammatory lesions measured by a VAS, measured in mm values (0 mm to 100 mm). The higher the value the more itching is experienced by the subject. |
at visit 5 (week 8) |
|
Secondary |
change in itch of the inflammatory lesions measured by a VAS |
itch of the inflammatory lesions measured by a VAS, measured in mm values (0 mm to 100 mm). The higher the value the more itching is experienced by the subject. |
at visit 6 (week 16) |
|
Secondary |
change in itch of the inflammatory lesions measured by a VAS |
itch of the inflammatory lesions measured by a VAS, measured in mm values (0 mm to 100 mm). The higher the value the more itching is experienced by the subject. |
at visit 7 (week 24) |
|
Secondary |
change in quality of life |
change in quality of life measured by Dermatology Life Quality Index (DLQI). The DLQI is calculated by summing the score of each of the 10 questions resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. |
Baseline to visit 3 (week 2) |
|
Secondary |
change in quality of life |
change in quality of life measured by Dermatology Life Quality Index (DLQI).The DLQI is calculated by summing the score of each of the 10 questions resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. |
Baseline to visit 4 (week 4) |
|
Secondary |
change in quality of life |
change in quality of life measured by Dermatology Life Quality Index (DLQI). The DLQI is calculated by summing the score of each of the 10 questions resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. |
Baseline to visit 5 (week 8) |
|
Secondary |
change in quality of life |
change in quality of life measured by Dermatology Life Quality Index (DLQI). The DLQI is calculated by summing the score of each of the 10 questions resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. |
Baseline to visit 6 (week 16) |
|
Secondary |
change in quality of life |
change in quality of life measured by Dermatology Life Quality Index (DLQI). The DLQI is calculated by summing the score of each of the 10 questions resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. |
Baseline to visit 7 (week 24) |
|
Secondary |
change in depression profile |
change in depression profile measured by Patient Health Questionnaire (PHQ-9). The PHQ-9 is the 9-item depression module from the full PHQ. As a severity measure, the PHQ-9 score can range from 0 to 27, since each of the 9-items can be scored from 0 (not at all) to 3 (nearly every day). |
Baseline to Visit 3 (week 2) |
|
Secondary |
change in depression profile |
change in depression profile measured by Patient Health Questionnaire (PHQ-9). The PHQ-9 is the 9-item depression module from the full PHQ. As a severity measure, the PHQ-9 score can range from 0 to 27, since each of the 9-items can be scored from 0 (not at all) to 3 (nearly every day). |
Baseline to Visit 4 (week 4) |
|
Secondary |
change in depression profile |
change in depression profile measured by Patient Health Questionnaire (PHQ-9).The PHQ-9 is the 9-item depression module from the full PHQ. As a severity measure, the PHQ-9 score can range from 0 to 27, since each of the 9-items can be scored from 0 (not at all) to 3 (nearly every day). |
Baseline to Visit 5 (week 8) |
|
Secondary |
change in depression profile |
change in depression profile measured by Patient Health Questionnaire (PHQ-9). The PHQ-9 is the 9-item depression module from the full PHQ. As a severity measure, the PHQ-9 score can range from 0 to 27, since each of the 9-items can be scored from 0 (not at all) to 3 (nearly every day). |
Baseline to Visit 6 (week 16) |
|
Secondary |
change in depression profile |
change in depression profile measured by Patient Health Questionnaire (PHQ-9). The PHQ-9 is the 9-item depression module from the full PHQ. As a severity measure, the PHQ-9 score can range from 0 to 27, since each of the 9-items can be scored from 0 (not at all) to 3 (nearly every day). |
Baseline to Visit 7 (week 24) |
|
Secondary |
compliance to therapy (drug accountability) |
compliance to therapy measured by drug accountability (counting of returned IMP) |
at visit 3 (week 2) |
|
Secondary |
compliance to therapy (drug accountability) |
compliance to therapy measured by drug accountability (counting of returned IMP) |
at visit 4 (week 4) |
|
Secondary |
compliance to therapy (drug accountability) |
compliance to therapy measured by drug accountability (counting of returned IMP) |
at visit 5 (week 8) |
|
Secondary |
compliance to therapy (drug accountability) |
compliance to therapy measured by drug accountability (counting of returned IMP) |
at visit 6 (week 16) |
|
Secondary |
compliance to therapy (drug accountability) |
compliance to therapy measured by drug accountability (counting of returned IMP) |
at visit 7 (week 24) |
|
Secondary |
Frequency of adverse events (AEs) |
Frequency of adverse events (AEs) as documented in Case Report Form (CRF) |
at visit 3 (week 2) |
|
Secondary |
Frequency of adverse events (AEs) |
Frequency of adverse events (AEs) as documented in Case Report Form (CRF) |
at visit 4 (week 4) |
|
Secondary |
Frequency of adverse events (AEs) |
Frequency of adverse events (AEs) as documented in Case Report Form (CRF) |
at visit 5 (week 8) |
|
Secondary |
Frequency of adverse events (AEs) |
Frequency of adverse events (AEs) as documented in Case Report Form (CRF) |
at visit 6 (week 16) |
|
Secondary |
Frequency of adverse events (AEs) |
Frequency of adverse events (AEs) as documented in Case Report Form (CRF) |
at visit 7 (week 24) |
|
Secondary |
Frequency of adverse events (AEs) |
Frequency of adverse events (AEs) as documented in Case Report Form (CRF) |
at Follow-up (week 28) |
|
Secondary |
Seriousness of adverse events (AEs) |
Determination of seriousness of adverse events (AEs) and rate of seriousness as documented in Case Report Form (CRF) |
at visit 3 (week 2) |
|
Secondary |
Seriousness of adverse events (AEs) |
Determination of seriousness of adverse events (AEs) and rate of seriousness as documented in Case Report Form (CRF) |
at visit 4 (week 4) |
|
Secondary |
Seriousness of adverse events (AEs) |
Determination of seriousness of adverse events (AEs) and rate of seriousness as documented in Case Report Form (CRF) |
at visit 5 (week 8) |
|
Secondary |
Seriousness of adverse events (AEs) |
Determination of seriousness of adverse events (AEs) and rate of seriousness as documented in Case Report Form (CRF) |
at visit 6 (week 18) |
|
Secondary |
Seriousness of adverse events (AEs) |
Determination of seriousness of adverse events (AEs) and rate of seriousness as documented in Case Report Form (CRF) |
at visit 7 (week 24) |
|
Secondary |
Seriousness of adverse events (AEs) |
Determination of seriousness of adverse events (AEs) and rate of seriousness as documented in Case Report Form (CRF) |
at Follow-up (week 28) |
|