Trial Outcomes & Findings for Phase 2b Dose-ranging Trial to Evaluate Delgocitinib Cream 1, 3, 8, and 20 mg/g Compared to Delgocitinib Cream Vehicle Over a 16-week Treatment Period in Adult Subjects With Chronic Hand Eczema (NCT NCT03683719)
NCT ID: NCT03683719
Last Updated: 2025-03-12
Results Overview
IGA-CHE is an instrument used in clinical trials to rate the severity of subject's global disease stage and is based on a 5-point scale ranging from 0 (clear) to 4 (severe). The multiple comparison procedure - modelling (MCP-Mod) approach was used to guide dose selection. Cochran-Mantel-Haenszel analysis was used to determine the difference in response rates between the active delgocitinib cream doses and delgocitinib cream vehicle.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
258 participants
Primary outcome timeframe
Week 0 to Week 16.
Results posted on
2025-03-12
Participant Flow
258 participants from 26 sites in 3 countries (U.S., Denmark, Germany) were randomised in this trial. The first participant was screened on 28-Nov-2018 and the last participant completed the trial on 20-Apr-2020.
305 participants were screened for this trial. Of these, 47 participants (15.4%) were screening failures. The main reason for screening failure was failure to meet eligibility criteria (11.8%). The eligibility criterion that was most frequently not met was exclusion criterion 21 (positive HBsAg, HBsAb, HBcAb, or antiHCV serology at screening \[3.3%\]).
Participant milestones
| Measure |
Delgocitinib Cream 1 mg/g
Delgocitinib cream applied twice daily for 16 weeks.
Delgocitinib cream: Cream for topical application.
|
Delgocitinib Cream 3 mg/g
Delgocitinib cream applied twice daily for 16 weeks.
Delgocitinib cream: Cream for topical application.
|
Delgocitinib Cream 8 mg/g
Delgocitinib cream applied twice daily for 16 weeks.
Delgocitinib cream: Cream for topical application.
|
Delgocitinib Cream 20 mg/g
Delgocitinib cream applied twice daily for 16 weeks.
Delgocitinib cream: Cream for topical application.
|
Delgocitinib Cream Vehicle
Delgocitinib cream vehicle applied twice daily for 16 weeks.
Delgocitinib cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
52
|
51
|
52
|
53
|
50
|
|
Overall Study
COMPLETED
|
40
|
38
|
44
|
46
|
36
|
|
Overall Study
NOT COMPLETED
|
12
|
13
|
8
|
7
|
14
|
Reasons for withdrawal
| Measure |
Delgocitinib Cream 1 mg/g
Delgocitinib cream applied twice daily for 16 weeks.
Delgocitinib cream: Cream for topical application.
|
Delgocitinib Cream 3 mg/g
Delgocitinib cream applied twice daily for 16 weeks.
Delgocitinib cream: Cream for topical application.
|
Delgocitinib Cream 8 mg/g
Delgocitinib cream applied twice daily for 16 weeks.
Delgocitinib cream: Cream for topical application.
|
Delgocitinib Cream 20 mg/g
Delgocitinib cream applied twice daily for 16 weeks.
Delgocitinib cream: Cream for topical application.
|
Delgocitinib Cream Vehicle
Delgocitinib cream vehicle applied twice daily for 16 weeks.
Delgocitinib cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.
|
|---|---|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
1
|
3
|
4
|
0
|
4
|
|
Overall Study
Adverse Event
|
6
|
6
|
0
|
1
|
3
|
|
Overall Study
Withdrawal by Subject
|
4
|
4
|
3
|
5
|
5
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
1
|
1
|
|
Overall Study
Other personal reasons
|
0
|
0
|
1
|
0
|
1
|
Baseline Characteristics
Phase 2b Dose-ranging Trial to Evaluate Delgocitinib Cream 1, 3, 8, and 20 mg/g Compared to Delgocitinib Cream Vehicle Over a 16-week Treatment Period in Adult Subjects With Chronic Hand Eczema
Baseline characteristics by cohort
| Measure |
Delgocitinib Cream 1 mg/g
n=52 Participants
Delgocitinib cream applied twice daily for 16 weeks.
Delgocitinib cream: Cream for topical application.
|
Delgocitinib Cream 3 mg/g
n=51 Participants
Delgocitinib cream applied twice daily for 16 weeks.
Delgocitinib cream: Cream for topical application.
|
Delgocitinib Cream 8 mg/g
n=52 Participants
Delgocitinib cream applied twice daily for 16 weeks.
Delgocitinib cream: Cream for topical application.
|
Delgocitinib Cream 20 mg/g
n=53 Participants
Delgocitinib cream applied twice daily for 16 weeks.
Delgocitinib cream: Cream for topical application.
|
Delgocitinib Cream Vehicle
n=50 Participants
Delgocitinib cream vehicle applied twice daily for 16 weeks.
Delgocitinib cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.
|
Total
n=258 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
44.3 years
STANDARD_DEVIATION 13.6 • n=99 Participants
|
46.1 years
STANDARD_DEVIATION 14.6 • n=107 Participants
|
47.9 years
STANDARD_DEVIATION 12.9 • n=206 Participants
|
43.9 years
STANDARD_DEVIATION 15.1 • n=7 Participants
|
47.8 years
STANDARD_DEVIATION 16.2 • n=31 Participants
|
46.0 years
STANDARD_DEVIATION 14.5 • n=30 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
34 Participants
n=7 Participants
|
27 Participants
n=31 Participants
|
158 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
19 Participants
n=7 Participants
|
23 Participants
n=31 Participants
|
100 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
9 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
49 Participants
n=99 Participants
|
51 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
52 Participants
n=7 Participants
|
47 Participants
n=31 Participants
|
249 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
51 Participants
n=99 Participants
|
51 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
52 Participants
n=7 Participants
|
50 Participants
n=31 Participants
|
254 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=99 Participants
|
4 participants
n=107 Participants
|
4 participants
n=206 Participants
|
5 participants
n=7 Participants
|
4 participants
n=31 Participants
|
21 participants
n=30 Participants
|
|
Region of Enrollment
Denmark
|
12 participants
n=99 Participants
|
7 participants
n=107 Participants
|
12 participants
n=206 Participants
|
11 participants
n=7 Participants
|
16 participants
n=31 Participants
|
58 participants
n=30 Participants
|
|
Region of Enrollment
Germany
|
36 participants
n=99 Participants
|
40 participants
n=107 Participants
|
36 participants
n=206 Participants
|
37 participants
n=7 Participants
|
30 participants
n=31 Participants
|
179 participants
n=30 Participants
|
|
Baseline IGA-CHE score
0 - Clear
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Baseline IGA-CHE score
1 - Almost clear
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Baseline IGA-CHE score
2 - Mild
|
13 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=31 Participants
|
61 Participants
n=30 Participants
|
|
Baseline IGA-CHE score
3 - Moderate
|
29 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
31 Participants
n=7 Participants
|
27 Participants
n=31 Participants
|
145 Participants
n=30 Participants
|
|
Baseline IGA-CHE score
4 - Severe
|
10 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
11 Participants
n=31 Participants
|
52 Participants
n=30 Participants
|
|
Baseline HECSI score
|
59.0 units on a scale
STANDARD_DEVIATION 48.0 • n=99 Participants
|
52.4 units on a scale
STANDARD_DEVIATION 35.9 • n=107 Participants
|
49.5 units on a scale
STANDARD_DEVIATION 29.3 • n=206 Participants
|
65.7 units on a scale
STANDARD_DEVIATION 58.3 • n=7 Participants
|
52.7 units on a scale
STANDARD_DEVIATION 34.9 • n=31 Participants
|
55.9 units on a scale
STANDARD_DEVIATION 42.8 • n=30 Participants
|
PRIMARY outcome
Timeframe: Week 0 to Week 16.Population: FAS
IGA-CHE is an instrument used in clinical trials to rate the severity of subject's global disease stage and is based on a 5-point scale ranging from 0 (clear) to 4 (severe). The multiple comparison procedure - modelling (MCP-Mod) approach was used to guide dose selection. Cochran-Mantel-Haenszel analysis was used to determine the difference in response rates between the active delgocitinib cream doses and delgocitinib cream vehicle.
Outcome measures
| Measure |
Delgocitinib Cream 1 mg/g
n=52 Participants
Delgocitinib cream applied twice daily for 16 weeks.
Delgocitinib cream: Cream for topical application.
|
Delgocitinib Cream 3 mg/g
n=51 Participants
Delgocitinib cream applied twice daily for 16 weeks.
Delgocitinib cream: Cream for topical application.
|
Delgocitinib Cream 8 mg/g
n=52 Participants
Delgocitinib cream applied twice daily for 16 weeks.
Delgocitinib cream: Cream for topical application.
|
Delgocitinib Cream 20 mg/g
n=53 Participants
Delgocitinib cream applied twice daily for 16 weeks.
Delgocitinib cream: Cream for topical application.
|
Delgocitinib Cream Vehicle
n=50 Participants
Delgocitinib cream vehicle applied twice daily for 16 weeks.
Delgocitinib cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.
|
|---|---|---|---|---|---|
|
Investigator's Global Assessment for Chronic Hand Eczema (IGA-CHE) Score of 0 (Clear) or 1 (Almost Clear) With at Least a 2-step Improvement (IGA-CHE Treatment Success) From Baseline to Week 16.
|
11 Participants
|
4 Participants
|
19 Participants
|
20 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Week 0 to Week 16.Population: FAS
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). The lowest HECSI score is 0 and the highest possible is 360. A higher HECSI score is indicating more severe hand eczema. The multiple comparison procedure - modelling (MCP-Mod) approach was used to guide dose selection. A mixed model for repeated measurements (MMRM) analysis was used to determine the difference in the continuous endpoint between the active delgocitinib cream doses and delgocitinib cream vehicle.
Outcome measures
| Measure |
Delgocitinib Cream 1 mg/g
n=52 Participants
Delgocitinib cream applied twice daily for 16 weeks.
Delgocitinib cream: Cream for topical application.
|
Delgocitinib Cream 3 mg/g
n=51 Participants
Delgocitinib cream applied twice daily for 16 weeks.
Delgocitinib cream: Cream for topical application.
|
Delgocitinib Cream 8 mg/g
n=52 Participants
Delgocitinib cream applied twice daily for 16 weeks.
Delgocitinib cream: Cream for topical application.
|
Delgocitinib Cream 20 mg/g
n=53 Participants
Delgocitinib cream applied twice daily for 16 weeks.
Delgocitinib cream: Cream for topical application.
|
Delgocitinib Cream Vehicle
n=50 Participants
Delgocitinib cream vehicle applied twice daily for 16 weeks.
Delgocitinib cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.
|
|---|---|---|---|---|---|
|
Change in Hand Eczema Severity Index (HECSI) From Baseline to Week 16.
|
-39.81 score on a scale
Standard Error 3.71
|
-35.93 score on a scale
Standard Error 3.77
|
-46.69 score on a scale
Standard Error 3.63
|
-41.99 score on a scale
Standard Error 3.59
|
-26.40 score on a scale
Standard Error 3.80
|
SECONDARY outcome
Timeframe: Week 0 to Week 16.Population: FAS
Time to IGA-CHE treatment success response is defined as the time from baseline to first assessment of an IGA-CHE score of 0 (clear) or 1 (almost clear) with at least a 2-step improvement.
Outcome measures
| Measure |
Delgocitinib Cream 1 mg/g
n=52 Participants
Delgocitinib cream applied twice daily for 16 weeks.
Delgocitinib cream: Cream for topical application.
|
Delgocitinib Cream 3 mg/g
n=51 Participants
Delgocitinib cream applied twice daily for 16 weeks.
Delgocitinib cream: Cream for topical application.
|
Delgocitinib Cream 8 mg/g
n=52 Participants
Delgocitinib cream applied twice daily for 16 weeks.
Delgocitinib cream: Cream for topical application.
|
Delgocitinib Cream 20 mg/g
n=53 Participants
Delgocitinib cream applied twice daily for 16 weeks.
Delgocitinib cream: Cream for topical application.
|
Delgocitinib Cream Vehicle
n=50 Participants
Delgocitinib cream vehicle applied twice daily for 16 weeks.
Delgocitinib cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.
|
|---|---|---|---|---|---|
|
Time to IGA-CHE Treatment Success.
|
NA days, median
The median time to achieve success in IGA-CHE was not estimable, as fewer participants (less than 50 percent) reached success in IGA-CHE.
|
NA days, median
The median time to achieve success in IGA-CHE was not estimable, as fewer participants (less than 50 percent) reached success in IGA-CHE.
|
82 days, median
|
98 days, median
|
NA days, median
The median time to achieve success in IGA-CHE was not estimable, as fewer participants (less than 50 percent) reached success in IGA-CHE.
|
Adverse Events
Delgocitinib Cream 1 mg/g
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Delgocitinib Cream 3 mg/g
Serious events: 2 serious events
Other events: 25 other events
Deaths: 0 deaths
Delgocitinib Cream 8 mg/g
Serious events: 1 serious events
Other events: 25 other events
Deaths: 0 deaths
Delgocitinib Cream 20 mg/g
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Delgocitinib Cream Vehicle
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Delgocitinib Cream 1 mg/g
n=52 participants at risk
Delgocitinib cream applied twice daily for 16 weeks.
Delgocitinib cream: Cream for topical application.
|
Delgocitinib Cream 3 mg/g
n=51 participants at risk
Delgocitinib cream applied twice daily for 16 weeks.
Delgocitinib cream: Cream for topical application.
|
Delgocitinib Cream 8 mg/g
n=52 participants at risk
Delgocitinib cream applied twice daily for 16 weeks.
Delgocitinib cream: Cream for topical application.
|
Delgocitinib Cream 20 mg/g
n=53 participants at risk
Delgocitinib cream applied twice daily for 16 weeks.
Delgocitinib cream: Cream for topical application.
|
Delgocitinib Cream Vehicle
n=50 participants at risk
Delgocitinib cream vehicle applied twice daily for 16 weeks.
Delgocitinib cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.
|
|---|---|---|---|---|---|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/52 • 18 weeks (from first application of IMP up until the last visit (safety follow-up visit))
|
2.0%
1/51 • Number of events 1 • 18 weeks (from first application of IMP up until the last visit (safety follow-up visit))
|
0.00%
0/52 • 18 weeks (from first application of IMP up until the last visit (safety follow-up visit))
|
0.00%
0/53 • 18 weeks (from first application of IMP up until the last visit (safety follow-up visit))
|
0.00%
0/50 • 18 weeks (from first application of IMP up until the last visit (safety follow-up visit))
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/52 • 18 weeks (from first application of IMP up until the last visit (safety follow-up visit))
|
0.00%
0/51 • 18 weeks (from first application of IMP up until the last visit (safety follow-up visit))
|
1.9%
1/52 • Number of events 1 • 18 weeks (from first application of IMP up until the last visit (safety follow-up visit))
|
0.00%
0/53 • 18 weeks (from first application of IMP up until the last visit (safety follow-up visit))
|
0.00%
0/50 • 18 weeks (from first application of IMP up until the last visit (safety follow-up visit))
|
|
Skin and subcutaneous tissue disorders
Pemphigoid
|
0.00%
0/52 • 18 weeks (from first application of IMP up until the last visit (safety follow-up visit))
|
2.0%
1/51 • Number of events 1 • 18 weeks (from first application of IMP up until the last visit (safety follow-up visit))
|
0.00%
0/52 • 18 weeks (from first application of IMP up until the last visit (safety follow-up visit))
|
0.00%
0/53 • 18 weeks (from first application of IMP up until the last visit (safety follow-up visit))
|
0.00%
0/50 • 18 weeks (from first application of IMP up until the last visit (safety follow-up visit))
|
Other adverse events
| Measure |
Delgocitinib Cream 1 mg/g
n=52 participants at risk
Delgocitinib cream applied twice daily for 16 weeks.
Delgocitinib cream: Cream for topical application.
|
Delgocitinib Cream 3 mg/g
n=51 participants at risk
Delgocitinib cream applied twice daily for 16 weeks.
Delgocitinib cream: Cream for topical application.
|
Delgocitinib Cream 8 mg/g
n=52 participants at risk
Delgocitinib cream applied twice daily for 16 weeks.
Delgocitinib cream: Cream for topical application.
|
Delgocitinib Cream 20 mg/g
n=53 participants at risk
Delgocitinib cream applied twice daily for 16 weeks.
Delgocitinib cream: Cream for topical application.
|
Delgocitinib Cream Vehicle
n=50 participants at risk
Delgocitinib cream vehicle applied twice daily for 16 weeks.
Delgocitinib cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.
|
|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
1.9%
1/52 • Number of events 1 • 18 weeks (from first application of IMP up until the last visit (safety follow-up visit))
|
5.9%
3/51 • Number of events 3 • 18 weeks (from first application of IMP up until the last visit (safety follow-up visit))
|
0.00%
0/52 • 18 weeks (from first application of IMP up until the last visit (safety follow-up visit))
|
0.00%
0/53 • 18 weeks (from first application of IMP up until the last visit (safety follow-up visit))
|
0.00%
0/50 • 18 weeks (from first application of IMP up until the last visit (safety follow-up visit))
|
|
Gastrointestinal disorders
Toothache
|
5.8%
3/52 • Number of events 3 • 18 weeks (from first application of IMP up until the last visit (safety follow-up visit))
|
2.0%
1/51 • Number of events 1 • 18 weeks (from first application of IMP up until the last visit (safety follow-up visit))
|
0.00%
0/52 • 18 weeks (from first application of IMP up until the last visit (safety follow-up visit))
|
0.00%
0/53 • 18 weeks (from first application of IMP up until the last visit (safety follow-up visit))
|
0.00%
0/50 • 18 weeks (from first application of IMP up until the last visit (safety follow-up visit))
|
|
Infections and infestations
Nasopharyngitis
|
17.3%
9/52 • Number of events 11 • 18 weeks (from first application of IMP up until the last visit (safety follow-up visit))
|
29.4%
15/51 • Number of events 22 • 18 weeks (from first application of IMP up until the last visit (safety follow-up visit))
|
28.8%
15/52 • Number of events 16 • 18 weeks (from first application of IMP up until the last visit (safety follow-up visit))
|
26.4%
14/53 • Number of events 20 • 18 weeks (from first application of IMP up until the last visit (safety follow-up visit))
|
40.0%
20/50 • Number of events 20 • 18 weeks (from first application of IMP up until the last visit (safety follow-up visit))
|
|
Skin and subcutaneous tissue disorders
Eczema
|
9.6%
5/52 • Number of events 5 • 18 weeks (from first application of IMP up until the last visit (safety follow-up visit))
|
7.8%
4/51 • Number of events 5 • 18 weeks (from first application of IMP up until the last visit (safety follow-up visit))
|
5.8%
3/52 • Number of events 7 • 18 weeks (from first application of IMP up until the last visit (safety follow-up visit))
|
11.3%
6/53 • Number of events 7 • 18 weeks (from first application of IMP up until the last visit (safety follow-up visit))
|
16.0%
8/50 • Number of events 9 • 18 weeks (from first application of IMP up until the last visit (safety follow-up visit))
|
|
Nervous system disorders
Headache
|
3.8%
2/52 • Number of events 2 • 18 weeks (from first application of IMP up until the last visit (safety follow-up visit))
|
3.9%
2/51 • Number of events 4 • 18 weeks (from first application of IMP up until the last visit (safety follow-up visit))
|
11.5%
6/52 • Number of events 7 • 18 weeks (from first application of IMP up until the last visit (safety follow-up visit))
|
7.5%
4/53 • Number of events 5 • 18 weeks (from first application of IMP up until the last visit (safety follow-up visit))
|
4.0%
2/50 • Number of events 2 • 18 weeks (from first application of IMP up until the last visit (safety follow-up visit))
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.8%
3/52 • Number of events 3 • 18 weeks (from first application of IMP up until the last visit (safety follow-up visit))
|
3.9%
2/51 • Number of events 2 • 18 weeks (from first application of IMP up until the last visit (safety follow-up visit))
|
1.9%
1/52 • Number of events 1 • 18 weeks (from first application of IMP up until the last visit (safety follow-up visit))
|
5.7%
3/53 • Number of events 3 • 18 weeks (from first application of IMP up until the last visit (safety follow-up visit))
|
2.0%
1/50 • Number of events 1 • 18 weeks (from first application of IMP up until the last visit (safety follow-up visit))
|
|
Infections and infestations
Influenza
|
1.9%
1/52 • Number of events 1 • 18 weeks (from first application of IMP up until the last visit (safety follow-up visit))
|
2.0%
1/51 • Number of events 1 • 18 weeks (from first application of IMP up until the last visit (safety follow-up visit))
|
0.00%
0/52 • 18 weeks (from first application of IMP up until the last visit (safety follow-up visit))
|
7.5%
4/53 • Number of events 4 • 18 weeks (from first application of IMP up until the last visit (safety follow-up visit))
|
0.00%
0/50 • 18 weeks (from first application of IMP up until the last visit (safety follow-up visit))
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.9%
1/52 • Number of events 1 • 18 weeks (from first application of IMP up until the last visit (safety follow-up visit))
|
0.00%
0/51 • 18 weeks (from first application of IMP up until the last visit (safety follow-up visit))
|
3.8%
2/52 • Number of events 2 • 18 weeks (from first application of IMP up until the last visit (safety follow-up visit))
|
5.7%
3/53 • Number of events 3 • 18 weeks (from first application of IMP up until the last visit (safety follow-up visit))
|
2.0%
1/50 • Number of events 1 • 18 weeks (from first application of IMP up until the last visit (safety follow-up visit))
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee LEO Pharma A/S seeks publication of all clinical trials in peer-reviewed journals within 18 months after completion or termination of the clinical trial, regardless of whether the findings are positive or negative. After such publication is made public, or if no publication is submitted by LEO Pharma A/S within these 18 months, the investigator has the right to publish the results from the clinical trial generated by him/herself.
- Publication restrictions are in place
Restriction type: OTHER