Chronic Hand Eczema
Conditions
Brief summary
The purpose of this trial is to test if delgocitinib cream is effective in treating chronic hand eczema (CHE) and to find out what side effects it may have compared with a cream vehicle with no active medical ingredient in adolescents aged 12-17 years. At each visit to the clinic, the doctor will assess the severity and extent of CHE, and during the trial, the adolescents will assess their CHE signs and symptoms as well as quality of life. The trial will last up to 22 weeks and has a 1-4 week screening period, a 16-week treatment period and a 2- week follow-up period. During the treatment period, each adolescent participant will use either the delgocitinib cream or cream vehicle twice daily.
Interventions
DRUGDelgocitinib
Cream for topical application
DRUGCream vehicle
The cream vehicle is similar to the delgocitinib cream except that it does not contain any active medical ingredient.
Sponsors
LEO Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Age 12 to 17 years at screening and baseline. * 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). * Subjects who have a documented recent history of inadequate response to treatment with topical corticosteroids (TCS) (at any time within 1 year before the screening visit) or for whom TCS are documented to be otherwise medically inadvisable (e.g. due to important side effects or safety risks). * Inadequate response is defined as a history of failure to achieve and maintain a low disease activity state (comparable to an IGA-CHE score of ≤2) despite treatment with a daily regimen of TCS of class III-IV (potent to very potent) for Europe and Australia and class IV-I (medium potency to very/ultra-high potency) for Canada, applied for at least 28 days or for the maximum duration recommended by the product prescribing information, whichever is shorter. * Important side effects or safety risks are those that outweigh the potential treatment benefits and include intolerance to treatment, hypersensitivity reactions, and significant skin atrophy as assessed by the physician.
Exclusion criteria
* Concurrent skin diseases on the hands, e.g. tinea manuum. * Clinically significant infection (e.g. impetiginised hand eczema) on the hands. * Systemic treatment with immunosuppressive drugs (e.g. methotrexate, cyclosporine, azathioprine), immunomodulating drugs, retinoids (e.g. alitretinoin), or corticosteroids within 28 days prior to baseline (steroid eyedrops and inhaled or intranasal steroids corresponding to up to 1 mg prednisolone for allergic conjunctivitis, asthma, or rhinitis are allowed). * Use of tanning beds, phototherapy (e.g. ultraviolet B (UVB), ultraviolet A1 (UVA1), psoralen ultraviolet A (PUVA)), or bleach baths on the hands within 28 days prior to baseline. * Previous or current treatment with JAK inhibitors (including delgocitinib/LEO 124249), systemic or topical. * Cutaneously applied treatment with immunomodulators (e.g. PDE-4 inhibitors, pimecrolimus, tacrolimus) or TCS on the hands within 14 days prior to baseline. * Use of systemic antibiotics or cutaneously applied antibiotics on the hands within 14 days prior to baseline. * Other cutaneously applied therapy on the hands (except for the use of subject's own emollients) within 7 days prior to baseline. * Cutaneously applied treatments in regions other than the hands, which could interfere with clinical trial evaluations or pose a safety concern within 7 days prior to baseline. * Any disorder which is not stable and could: * Affect the safety of the subject throughout the trial. * Impede the subject's ability to complete the trial. Examples include but are not limited to cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, immunological, and psychiatric disorders, and major physical impairment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With IGA-CHE Treatment Success at Week 16 | Week 16 | The Investigator's Global Assessment for chronic hand eczema (IGA-CHE) is a 5 point scale used in clinical trials to rate the severity of the subject's CHE from 0 (clear) to 4 (severe). Treatment success means a score of 0 (clear) or 1 (almost clear) with a ≥2 step improvement from baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With HECSI-90 at Week 16 | Week 16 | 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), with a higher score indicating greater severity. HECSI-90 is defined as at least 90% improvement in HECSI score from baseline. |
| Number of Participants With Reduction of HESD Itch Score (Weekly Average) of ≥4 Points From Baseline at Week 16 | Week 16 | The Hand Eczema Symptom Diary© (HESD) is an instrument designed to assess severity of CHE signs and symptoms. The participants will assess the worst severity of 6 individual signs and symptoms of CHE from 0 (none) to 10 (severe) over the past 24 hours. The participants will complete the HESD on a daily basis in an eDiary.' This endpoint will only assess the 'itch' component for participants with a baseline HESD itch score (weekly average) of ≥4 points. |
| Number of Participants With Reduction of HESD Pain Score (Weekly Average) of ≥4 Points From Baseline at Week 16 | Week 16 | The Hand Eczema Symptom Diary© (HESD) is an instrument designed to assess severity of CHE signs and symptoms. The participants will assess the worst severity of 6 individual signs and symptoms of CHE from 0 (none) to 10 (severe) over the past 24 hours. The participants will complete the HESD on a daily basis in an eDiary.' This endpoint will only assess the 'pain' component for participants with a baseline HESD pain score (weekly average) of ≥4 points. |
| Number of Participants With IGA-CHE Treatment Success at Week 2 | Week 2 | The Investigator's Global Assessment for chronic hand eczema (IGA-CHE) is a 5 point scale used in clinical trials to rate the severity of the subject's CHE from 0 (clear) to 4 (severe). Treatment success means a score of 0 (clear) or 1 (almost clear) with a ≥2 step improvement from baseline. |
| Number of Participants With Reduction of HESD Score (Weekly Average) of ≥4 Points From Baseline at Week 16 | Week 16 | The Hand Eczema Symptom Diary© (HESD) is an instrument designed to assess severity of CHE signs and symptoms. The participants will assess the worst severity of 6 individual signs and symptoms of CHE from 0 (none) to 10 (severe) over the past 24 hours. The participants will complete the HESD on a daily basis in an eDiary.' The final HESD score is an average of these 6 individual scores. This endpoint will only assess the score for participants with a baseline HESD itch score (weekly average) of ≥4 points. |
| Number of Participants With IGA-CHE Treatment Success at Week 8 | Week 8 | The Investigator's Global Assessment for chronic hand eczema© (IGA-CHE) is a 5 point scale used in clinical trials to rate the severity of the subject's CHE from 0 (clear) to 4 (severe). Treatment success means a score of 0 (clear) or 1 (almost clear) with a ≥2 step improvement from baseline. |
| Number of Participants With IGA-CHE Treatment Success at Week 12 | Week 12 | The Investigator's Global Assessment for chronic hand eczema© (IGA-CHE) is a 5 point scale used in clinical trials to rate the severity of the subject's CHE from 0 (clear) to 4 (severe). Treatment success means a score of 0 (clear) or 1 (almost clear) with a ≥2 step improvement from baseline. |
| Change in CDLQI Score From Baseline to Week 16 | Week 16 | The Children's Dermatology Life Quality Index (CDLQI) 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. Each question is scored from 0 (no impact) to 3 (high impact). The CDLQI score is the sum of the 10 items (score ranging from 0 to 30); a high score is indicative of a poor quality of life. |
| Number of Treatment Emergent AEs From Baseline up to Week 18 | Week 18 | An adverse event (AE) will be considered treatment emergent if started after the first application of treatment, or started before the first application of treatment and worsened in severity after treatment. |
| Number of Participants With IGA-CHE Treatment Success at Week 4 | Week 4 | The Investigator's Global Assessment for chronic hand eczema© (IGA-CHE) is a 5 point scale used in clinical trials to rate the severity of the subject's CHE from 0 (clear) to 4 (severe). Treatment success means a score of 0 (clear) or 1 (almost clear) with a ≥2 step improvement from baseline. |
Countries
Australia, Belgium, Canada, France, Poland, Spain, United Kingdom
Participant flow
Recruitment details
This trial was conducted at sites in 7 countries (Australia, Belgium, Canada, Spain, France, United Kingdom, and Poland).
Pre-assignment details
Participants were randomized 3:1 to treatment with delgocitinib cream 20 mg/g or cream vehicle.
Participants by arm
| Arm | Count |
|---|---|
| Delgocitinib Cream Participants were randomized to twice-daily topical applications of delgocitinib cream 20 mg/g for a 16-week treatment period followed by a follow-up period of 2 weeks for assessment of safety.
Delgocitinib cream: Cream for topical application. | 74 |
| Cream Vehicle Participants were randomized to twice-daily applications of cream vehicle for a 16-week treatment period followed by a follow-up period of 2 weeks for assessment of safety.
Cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active medical ingredient. | 24 |
| Total | 98 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 |
| Overall Study | Lack of Efficacy | 2 | 1 |
| Overall Study | Lost to Follow-up | 0 | 1 |
Baseline characteristics
| Characteristic | Delgocitinib Cream | Cream Vehicle | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 74 Participants | 24 Participants | 98 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 14.6 years STANDARD_DEVIATION 1.7 | 14.7 years STANDARD_DEVIATION 1.6 | 14.6 years STANDARD_DEVIATION 1.7 |
| CDLQI score | 8.5 scores on a scale STANDARD_DEVIATION 5.5 | 9.6 scores on a scale STANDARD_DEVIATION 6.8 | 8.8 scores on a scale STANDARD_DEVIATION 5.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 0 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 62 Participants | 21 Participants | 83 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants | 3 Participants | 7 Participants |
| HECSI score | 70.9 scores on a scale STANDARD_DEVIATION 37.8 | 76.2 scores on a scale STANDARD_DEVIATION 39.7 | 72.2 scores on a scale STANDARD_DEVIATION 38.1 |
| HESD itch score (weekly average) | 5.56 scores on a scale STANDARD_DEVIATION 2.59 | 5.91 scores on a scale STANDARD_DEVIATION 3.01 | 5.65 scores on a scale STANDARD_DEVIATION 2.69 |
| HESD pain score (weekly average) | 5.20 scores on a scale STANDARD_DEVIATION 2.75 | 5.65 scores on a scale STANDARD_DEVIATION 3.49 | 5.31 scores on a scale STANDARD_DEVIATION 2.94 |
| HESD score (weekly average) | 5.63 scores on a scale STANDARD_DEVIATION 2.26 | 5.75 scores on a scale STANDARD_DEVIATION 3 | 5.66 scores on a scale STANDARD_DEVIATION 2.45 |
| IGA-CHE score Almost clear | 0 Participants | 0 Participants | 0 Participants |
| IGA-CHE score Clear | 0 Participants | 0 Participants | 0 Participants |
| IGA-CHE score Mild | 0 Participants | 0 Participants | 0 Participants |
| IGA-CHE score Moderate | 56 Participants | 18 Participants | 74 Participants |
| IGA-CHE score Severe | 18 Participants | 6 Participants | 24 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) White | 69 Participants | 20 Participants | 89 Participants |
| Region of Enrollment Australia | 10 participants | 4 participants | 14 participants |
| Region of Enrollment Belgium | 2 participants | 0 participants | 2 participants |
| Region of Enrollment Canada | 6 participants | 1 participants | 7 participants |
| Region of Enrollment France | 11 participants | 5 participants | 16 participants |
| Region of Enrollment Poland | 23 participants | 9 participants | 32 participants |
| Region of Enrollment Spain | 17 participants | 3 participants | 20 participants |
| Region of Enrollment United Kingdom | 5 participants | 2 participants | 7 participants |
| Sex: Female, Male Female | 46 Participants | 12 Participants | 58 Participants |
| Sex: Female, Male Male | 28 Participants | 12 Participants | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 74 | 0 / 24 |
| other Total, other adverse events | 17 / 74 | 4 / 24 |
| serious Total, serious adverse events | 0 / 74 | 0 / 24 |
Outcome results
Primary
Number of Participants With IGA-CHE Treatment Success at Week 16
The Investigator's Global Assessment for chronic hand eczema (IGA-CHE) is a 5 point scale used in clinical trials to rate the severity of the subject's CHE from 0 (clear) to 4 (severe). Treatment success means a score of 0 (clear) or 1 (almost clear) with a ≥2 step improvement from baseline.
Time frame: Week 16
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Delgocitinib Cream | Number of Participants With IGA-CHE Treatment Success at Week 16 | 47 Participants |
| Cream Vehicle | Number of Participants With IGA-CHE Treatment Success at Week 16 | 7 Participants |
Comparison: Based on the primary estimand 'composite'. Data considered non-response after initiation of rescue treatment or after permanent discontinuation of IMP. Missing data imputed as non-response.Bayesian
Secondary
Change in CDLQI Score From Baseline to Week 16
The Children's Dermatology Life Quality Index (CDLQI) 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. Each question is scored from 0 (no impact) to 3 (high impact). The CDLQI score is the sum of the 10 items (score ranging from 0 to 30); a high score is indicative of a poor quality of life.
Time frame: Week 16
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Delgocitinib Cream | Change in CDLQI Score From Baseline to Week 16 | -5.57 score on a scale | Standard Error 0.44 |
| Cream Vehicle | Change in CDLQI Score From Baseline to Week 16 | -2.92 score on a scale | Standard Error 0.78 |
Comparison: Primary estimand: Composite. Data considered non-response by using WOCF (including the baseline value) after initiation of rescue treatment or after permanent discontinuation of IMP. Missing data imputed using WOCF (including the baseline value).p-value: 0.003895% CI: [-4.42, -0.88]ANCOVA
Secondary
Number of Participants With HECSI-90 at Week 16
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), with a higher score indicating greater severity. HECSI-90 is defined as at least 90% improvement in HECSI score from baseline.
Time frame: Week 16
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Delgocitinib Cream | Number of Participants With HECSI-90 at Week 16 | 53 Participants |
| Cream Vehicle | Number of Participants With HECSI-90 at Week 16 | 9 Participants |
Comparison: Primary estimand: Composite. Data considered non-response after initiation of rescue treatment or after permanent discontinuation of IMP. Missing data imputed as non-response.Bayesian
Secondary
Number of Participants With IGA-CHE Treatment Success at Week 12
The Investigator's Global Assessment for chronic hand eczema© (IGA-CHE) is a 5 point scale used in clinical trials to rate the severity of the subject's CHE from 0 (clear) to 4 (severe). Treatment success means a score of 0 (clear) or 1 (almost clear) with a ≥2 step improvement from baseline.
Time frame: Week 12
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Delgocitinib Cream | Number of Participants With IGA-CHE Treatment Success at Week 12 | 43 Participants |
| Cream Vehicle | Number of Participants With IGA-CHE Treatment Success at Week 12 | 6 Participants |
Comparison: The primary estimand using the composite strategy is used for the analysis. Data is considered non response after initiation of rescue treatment or after permanent discontinuation of IMP. Missing data is imputed as non-response.p-value: 0.001695% CI: [12.51, 53.52]Regression, Logistic
Secondary
Number of Participants With IGA-CHE Treatment Success at Week 2
The Investigator's Global Assessment for chronic hand eczema (IGA-CHE) is a 5 point scale used in clinical trials to rate the severity of the subject's CHE from 0 (clear) to 4 (severe). Treatment success means a score of 0 (clear) or 1 (almost clear) with a ≥2 step improvement from baseline.
Time frame: Week 2
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Delgocitinib Cream | Number of Participants With IGA-CHE Treatment Success at Week 2 | 16 Participants |
| Cream Vehicle | Number of Participants With IGA-CHE Treatment Success at Week 2 | 1 Participants |
Comparison: The primary estimand using the composite strategy is used for the analysis. Data is considered non response after initiation of rescue treatment or after permanent discontinuation of IMP. Missing data is imputed as non-response.p-value: 0.005495% CI: [5.16, 29.78]Regression, Logistic
Secondary
Number of Participants With IGA-CHE Treatment Success at Week 4
The Investigator's Global Assessment for chronic hand eczema© (IGA-CHE) is a 5 point scale used in clinical trials to rate the severity of the subject's CHE from 0 (clear) to 4 (severe). Treatment success means a score of 0 (clear) or 1 (almost clear) with a ≥2 step improvement from baseline.
Time frame: Week 4
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Delgocitinib Cream | Number of Participants With IGA-CHE Treatment Success at Week 4 | 28 Participants |
| Cream Vehicle | Number of Participants With IGA-CHE Treatment Success at Week 4 | 4 Participants |
Comparison: The primary estimand using the composite strategy is used for the analysis. Data is considered non response after initiation of rescue treatment or after permanent discontinuation of IMP. Missing data is imputed as non-response.p-value: 0.024895% CI: [2.69, 39.72]Regression, Logistic
Secondary
Number of Participants With IGA-CHE Treatment Success at Week 8
The Investigator's Global Assessment for chronic hand eczema© (IGA-CHE) is a 5 point scale used in clinical trials to rate the severity of the subject's CHE from 0 (clear) to 4 (severe). Treatment success means a score of 0 (clear) or 1 (almost clear) with a ≥2 step improvement from baseline.
Time frame: Week 8
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Delgocitinib Cream | Number of Participants With IGA-CHE Treatment Success at Week 8 | 36 Participants |
| Cream Vehicle | Number of Participants With IGA-CHE Treatment Success at Week 8 | 9 Participants |
Comparison: The primary estimand using the composite strategy is used for the analysis. Data is considered non response after initiation of rescue treatment or after permanent discontinuation of IMP. Missing data is imputed as non-response.p-value: 0.33295% CI: [-11.3, 33.46]Regression, Logistic
Secondary
Number of Participants With Reduction of HESD Itch Score (Weekly Average) of ≥4 Points From Baseline at Week 16
The Hand Eczema Symptom Diary© (HESD) is an instrument designed to assess severity of CHE signs and symptoms. The participants will assess the worst severity of 6 individual signs and symptoms of CHE from 0 (none) to 10 (severe) over the past 24 hours. The participants will complete the HESD on a daily basis in an eDiary.' This endpoint will only assess the 'itch' component for participants with a baseline HESD itch score (weekly average) of ≥4 points.
Time frame: Week 16
Population: Data is not available for 20 participants in the Delgocitinib cream group and for 5 participants in the cream vehicle group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Delgocitinib Cream | Number of Participants With Reduction of HESD Itch Score (Weekly Average) of ≥4 Points From Baseline at Week 16 | 35 Participants |
| Cream Vehicle | Number of Participants With Reduction of HESD Itch Score (Weekly Average) of ≥4 Points From Baseline at Week 16 | 7 Participants |
Bayesian
Secondary
Number of Participants With Reduction of HESD Pain Score (Weekly Average) of ≥4 Points From Baseline at Week 16
The Hand Eczema Symptom Diary© (HESD) is an instrument designed to assess severity of CHE signs and symptoms. The participants will assess the worst severity of 6 individual signs and symptoms of CHE from 0 (none) to 10 (severe) over the past 24 hours. The participants will complete the HESD on a daily basis in an eDiary.' This endpoint will only assess the 'pain' component for participants with a baseline HESD pain score (weekly average) of ≥4 points.
Time frame: Week 16
Population: Data is not available for 25 participants in the Delgocitinib cream group and for 9 participants in the cream vehicle group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Delgocitinib Cream | Number of Participants With Reduction of HESD Pain Score (Weekly Average) of ≥4 Points From Baseline at Week 16 | 31 Participants |
| Cream Vehicle | Number of Participants With Reduction of HESD Pain Score (Weekly Average) of ≥4 Points From Baseline at Week 16 | 5 Participants |
Bayesian
Secondary
Number of Participants With Reduction of HESD Score (Weekly Average) of ≥4 Points From Baseline at Week 16
The Hand Eczema Symptom Diary© (HESD) is an instrument designed to assess severity of CHE signs and symptoms. The participants will assess the worst severity of 6 individual signs and symptoms of CHE from 0 (none) to 10 (severe) over the past 24 hours. The participants will complete the HESD on a daily basis in an eDiary.' The final HESD score is an average of these 6 individual scores. This endpoint will only assess the score for participants with a baseline HESD itch score (weekly average) of ≥4 points.
Time frame: Week 16
Population: Data is not available for 20 participants in the Delgocitinib cream group and for 8 participants in the cream vehicle group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Delgocitinib Cream | Number of Participants With Reduction of HESD Score (Weekly Average) of ≥4 Points From Baseline at Week 16 | 30 Participants |
| Cream Vehicle | Number of Participants With Reduction of HESD Score (Weekly Average) of ≥4 Points From Baseline at Week 16 | 5 Participants |
Comparison: Primary estimand: Composite. Data considered non-response after initiation of rescue treatment or after permanent discontinuation of IMP. Missing data imputed as non-response.Bayesian
Secondary
Number of Treatment Emergent AEs From Baseline up to Week 18
An adverse event (AE) will be considered treatment emergent if started after the first application of treatment, or started before the first application of treatment and worsened in severity after treatment.
Time frame: Week 18
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Delgocitinib Cream | Number of Treatment Emergent AEs From Baseline up to Week 18 | 77 events |
| Cream Vehicle | Number of Treatment Emergent AEs From Baseline up to Week 18 | 19 events |