NCT05355818|CompletedPhase 3ResultsDMCFDA Drug

Efficacy and Safety of Delgocitinib Cream in Adolescents 12-17 Years of Age With Moderate to Severe Chronic Hand Eczema

DELTA TEEN

A Phase 3 Clinical Trial to Evaluate Efficacy and Safety of Twice-daily Applications of Delgocitinib Cream 20 mg/g Compared With Cream Vehicle for a 16-week Treatment Period in Adolescents 12-17 Years of Age With Moderate to Severe Chronic Hand Eczema (DELTA TEEN)

LEO Pharma ClinicalTrials.gov

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3 other identifiers

LP0133-14262021-006340-27U1111-1284-2122

Study Type

interventional

Target

Locations

7 countries

Sites

Timeline

RegisteredMay 2022

StartedJul 2022

CompletionDec 2024

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for phase_3

Timeline

Completed

Started Jul 2022

Geographic Reach

7 countries

37 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.4 years study duration

First Submitted

Initial submission to the registry

April 27, 2022

Completed

5 days until next milestone

First Posted

Study publicly available on registry

May 2, 2022

Completed

2 months until next milestone

Study Start

First participant enrolled

July 14, 2022

Completed

2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2024

Completed

12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 17, 2024

Completed

7 months until next milestone

Results Posted

Study results publicly available

July 2, 2025

Completed

Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

2.4 years

First QC Date

April 27, 2022

Results QC Date

June 17, 2025

Last Update Submit

April 13, 2026

Conditions

Chronic Hand Eczema

Outcome Measures

Primary Outcomes (1)

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.
Week 16

Secondary Outcomes (10)

Number of Participants With HECSI-90 at Week 16
Week 16
Number of Participants With Reduction of HESD Itch Score (Weekly Average) of ≥4 Points From Baseline at Week 16
Week 16
Number of Participants With Reduction of HESD Pain Score (Weekly Average) of ≥4 Points From Baseline at Week 16
Week 16
Number of Participants With Reduction of HESD Score (Weekly Average) of ≥4 Points From Baseline at Week 16
Week 16
Number of Participants With IGA-CHE Treatment Success at Week 2
Week 2
+5 more secondary outcomes

Study Arms (2)

Delgocitinib cream

EXPERIMENTAL

Delgocitinib cream 20 mg/g twice daily

Drug: Delgocitinib

Cream vehicle

PLACEBO COMPARATOR

Cream vehicle twice daily

Drug: Cream vehicle

Interventions

DelgocitinibDRUG

Cream for topical application

Delgocitinib cream

Cream vehicleDRUG

The cream vehicle is similar to the delgocitinib cream except that it does not contain any active medical ingredient.

Cream vehicle

Eligibility Criteria

Age12 Years - 17 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

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.

You may not qualify if:

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.

Contact the study team to confirm eligibility.