Trial Outcomes & Findings for Efficacy and Safety of Delgocitinib Cream in Adolescents 12-17 Years of Age With Moderate to Severe Chronic Hand Eczema (NCT NCT05355818)

Last Updated: 2025-07-29

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

98 participants

Primary outcome timeframe

Week 16

Results posted on

2025-07-29

Participant Flow

This trial was conducted at sites in 7 countries (Australia, Belgium, Canada, Spain, France, United Kingdom, and Poland).

Participants were randomized 3:1 to treatment with delgocitinib cream 20 mg/g or cream vehicle.

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	74	24
Overall Study COMPLETED	71	21
Overall Study NOT COMPLETED	3	3

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Adverse Event	1	1
Overall Study Lack of Efficacy	2	1
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

Data is missing for 1 participant in the delgocitinib cream group.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Delgocitinib Cream n=74 Participants 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.	Cream Vehicle n=24 Participants 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.	Total n=98 Participants Total of all reporting groups
Age, Categorical <=18 years	74 Participants n=74 Participants	24 Participants n=24 Participants	98 Participants n=98 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=74 Participants	0 Participants n=24 Participants	0 Participants n=98 Participants
Age, Categorical >=65 years	0 Participants n=74 Participants	0 Participants n=24 Participants	0 Participants n=98 Participants
Age, Continuous	14.6 years STANDARD_DEVIATION 1.7 • n=74 Participants	14.7 years STANDARD_DEVIATION 1.6 • n=24 Participants	14.6 years STANDARD_DEVIATION 1.7 • n=98 Participants
Sex: Female, Male Female	46 Participants n=74 Participants	12 Participants n=24 Participants	58 Participants n=98 Participants
Sex: Female, Male Male	28 Participants n=74 Participants	12 Participants n=24 Participants	40 Participants n=98 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=74 Participants	0 Participants n=24 Participants	8 Participants n=98 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	62 Participants n=74 Participants	21 Participants n=24 Participants	83 Participants n=98 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=74 Participants	3 Participants n=24 Participants	7 Participants n=98 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=74 Participants	0 Participants n=24 Participants	0 Participants n=98 Participants
Race (NIH/OMB) Asian	1 Participants n=74 Participants	2 Participants n=24 Participants	3 Participants n=98 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=74 Participants	0 Participants n=24 Participants	0 Participants n=98 Participants
Race (NIH/OMB) Black or African American	2 Participants n=74 Participants	0 Participants n=24 Participants	2 Participants n=98 Participants
Race (NIH/OMB) White	69 Participants n=74 Participants	20 Participants n=24 Participants	89 Participants n=98 Participants
Race (NIH/OMB) More than one race	0 Participants n=74 Participants	0 Participants n=24 Participants	0 Participants n=98 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=74 Participants	2 Participants n=24 Participants	4 Participants n=98 Participants
Region of Enrollment Canada	6 participants n=74 Participants	1 participants n=24 Participants	7 participants n=98 Participants
Region of Enrollment Belgium	2 participants n=74 Participants	0 participants n=24 Participants	2 participants n=98 Participants
Region of Enrollment Poland	23 participants n=74 Participants	9 participants n=24 Participants	32 participants n=98 Participants
Region of Enrollment United Kingdom	5 participants n=74 Participants	2 participants n=24 Participants	7 participants n=98 Participants
Region of Enrollment Australia	10 participants n=74 Participants	4 participants n=24 Participants	14 participants n=98 Participants
Region of Enrollment France	11 participants n=74 Participants	5 participants n=24 Participants	16 participants n=98 Participants
Region of Enrollment Spain	17 participants n=74 Participants	3 participants n=24 Participants	20 participants n=98 Participants
IGA-CHE score Clear	0 Participants n=74 Participants	0 Participants n=24 Participants	0 Participants n=98 Participants
IGA-CHE score Almost clear	0 Participants n=74 Participants	0 Participants n=24 Participants	0 Participants n=98 Participants
IGA-CHE score Mild	0 Participants n=74 Participants	0 Participants n=24 Participants	0 Participants n=98 Participants
IGA-CHE score Moderate	56 Participants n=74 Participants	18 Participants n=24 Participants	74 Participants n=98 Participants
IGA-CHE score Severe	18 Participants n=74 Participants	6 Participants n=24 Participants	24 Participants n=98 Participants
HECSI score	70.9 scores on a scale STANDARD_DEVIATION 37.8 • n=74 Participants	76.2 scores on a scale STANDARD_DEVIATION 39.7 • n=24 Participants	72.2 scores on a scale STANDARD_DEVIATION 38.1 • n=98 Participants
HESD itch score (weekly average)	5.56 scores on a scale STANDARD_DEVIATION 2.59 • n=73 Participants • Data is missing for 1 participant in the delgocitinib cream group.	5.91 scores on a scale STANDARD_DEVIATION 3.01 • n=24 Participants • Data is missing for 1 participant in the delgocitinib cream group.	5.65 scores on a scale STANDARD_DEVIATION 2.69 • n=97 Participants • Data is missing for 1 participant in the delgocitinib cream group.
HESD pain score (weekly average)	5.20 scores on a scale STANDARD_DEVIATION 2.75 • n=73 Participants • Data is missing for 1 participant in the delgocitinib cream group.	5.65 scores on a scale STANDARD_DEVIATION 3.49 • n=24 Participants • Data is missing for 1 participant in the delgocitinib cream group.	5.31 scores on a scale STANDARD_DEVIATION 2.94 • n=97 Participants • Data is missing for 1 participant in the delgocitinib cream group.
HESD score (weekly average)	5.63 scores on a scale STANDARD_DEVIATION 2.26 • n=73 Participants • Data is missing for 1 participant in the delgocitinib cream group.	5.75 scores on a scale STANDARD_DEVIATION 3.00 • n=24 Participants • Data is missing for 1 participant in the delgocitinib cream group.	5.66 scores on a scale STANDARD_DEVIATION 2.45 • n=97 Participants • Data is missing for 1 participant in the delgocitinib cream group.
CDLQI score	8.5 scores on a scale STANDARD_DEVIATION 5.5 • n=74 Participants	9.6 scores on a scale STANDARD_DEVIATION 6.8 • n=24 Participants	8.8 scores on a scale STANDARD_DEVIATION 5.8 • n=98 Participants

PRIMARY outcome

Timeframe: Week 16

Outcome measures

Outcome measures
Measure	Delgocitinib Cream n=74 Participants 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.	Cream Vehicle n=24 Participants 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.
Number of Participants With IGA-CHE Treatment Success at Week 16	47 Participants	7 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Delgocitinib Cream n=74 Participants 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.	Cream Vehicle n=24 Participants 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.
Number of Participants With HECSI-90 at Week 16	53 Participants	9 Participants

SECONDARY outcome

Timeframe: Week 16

Population: Data is not available for 20 participants in the Delgocitinib cream group and for 5 participants in the cream vehicle group.

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.

Outcome measures

Outcome measures
Measure	Delgocitinib Cream n=54 Participants 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.	Cream Vehicle n=19 Participants 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.
Number of Participants With Reduction of HESD Itch Score (Weekly Average) of ≥4 Points From Baseline at Week 16	35 Participants	7 Participants

SECONDARY outcome

Timeframe: Week 16

Population: Data is not available for 25 participants in the Delgocitinib cream group and for 9 participants in the cream vehicle group.

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.

Outcome measures

Outcome measures
Measure	Delgocitinib Cream n=49 Participants 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.	Cream Vehicle n=15 Participants 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.
Number of Participants With Reduction of HESD Pain Score (Weekly Average) of ≥4 Points From Baseline at Week 16	31 Participants	5 Participants

SECONDARY outcome

Timeframe: Week 16

Population: Data is not available for 20 participants in the Delgocitinib cream group and for 8 participants in the cream vehicle group.

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.

Outcome measures

Outcome measures
Measure	Delgocitinib Cream n=54 Participants 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.	Cream Vehicle n=16 Participants 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.
Number of Participants With Reduction of HESD Score (Weekly Average) of ≥4 Points From Baseline at Week 16	30 Participants	5 Participants

SECONDARY outcome

Timeframe: Week 2

Outcome measures

Outcome measures
Measure	Delgocitinib Cream n=74 Participants 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.	Cream Vehicle n=24 Participants 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.
Number of Participants With IGA-CHE Treatment Success at Week 2	16 Participants	1 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Delgocitinib Cream n=74 Participants 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.	Cream Vehicle n=24 Participants 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.
Number of Participants With IGA-CHE Treatment Success at Week 4	28 Participants	4 Participants

SECONDARY outcome

Timeframe: Week 8

Outcome measures

Outcome measures
Measure	Delgocitinib Cream n=74 Participants 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.	Cream Vehicle n=24 Participants 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.
Number of Participants With IGA-CHE Treatment Success at Week 8	36 Participants	9 Participants

SECONDARY outcome

Timeframe: Week 12

Outcome measures

Outcome measures
Measure	Delgocitinib Cream n=74 Participants 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.	Cream Vehicle n=24 Participants 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.
Number of Participants With IGA-CHE Treatment Success at Week 12	43 Participants	6 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Delgocitinib Cream n=74 Participants 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.	Cream Vehicle n=24 Participants 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.
Change in CDLQI Score From Baseline to Week 16	-5.57 score on a scale Standard Error 0.44	-2.92 score on a scale Standard Error 0.78

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Delgocitinib Cream n=74 Participants 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.	Cream Vehicle n=24 Participants 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.
Number of Treatment Emergent AEs From Baseline up to Week 18	77 events	19 events

Adverse Events

Delgocitinib Cream

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Cream Vehicle

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Delgocitinib Cream n=74 participants at risk 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.	Cream Vehicle n=24 participants at risk 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.
Infections and infestations Nasopharyngitis	13.5% 10/74 • Number of events 12 • Treatment emergent adverse events were collected during the 16 weeks of treatment + 2 weeks of follow-up.	16.7% 4/24 • Number of events 4 • Treatment emergent adverse events were collected during the 16 weeks of treatment + 2 weeks of follow-up.
Infections and infestations Upper respiratory tract infection	6.8% 5/74 • Number of events 5 • Treatment emergent adverse events were collected during the 16 weeks of treatment + 2 weeks of follow-up.	0.00% 0/24 • Treatment emergent adverse events were collected during the 16 weeks of treatment + 2 weeks of follow-up.
Nervous system disorders Headache	5.4% 4/74 • Number of events 4 • Treatment emergent adverse events were collected during the 16 weeks of treatment + 2 weeks of follow-up.	4.2% 1/24 • Number of events 1 • Treatment emergent adverse events were collected during the 16 weeks of treatment + 2 weeks of follow-up.

Additional Information

Clinical Disclosure

LEO Pharma A/S

Phone: +45 4494 5888

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The sponsor seeks publication of all clinical trials in peer-reviewed journals within 12 months after completion or termination of the clinical trial, regardless of whether the findings are positive or negative. If no publication is submitted by the sponsor within these 12 months, the investigator has the right to publish the results from clinical trial generated by him/herself.
Publication restrictions are in place

Restriction type: OTHER