Atopic Dermatitis
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Atopic Dermatitis
LP0133-1401 Enrolling

Research Trial for Hand Eczema (22 Weeks)


Age: 18 Years

Adults aged 18 years or older with a diagnosis of chronic hand eczema that has persisted for more than 3 months or returned twice or more within the last 12 months, may qualify to participate. Individuals must have moderate to severe disease, as well as a documented recent history of inadequate response to treatment with topical corticosteroids (at any time within 1 year before the screening visit) or for whom topical corticosteroids are documented to be otherwise medically inadvisable (e.g. due to important side effects or safety risks). Individuals will be asked to complete an eDiary on a daily basis and assess the worst severity of 6 individual signs and symptoms (itch, pain, cracking, redness, dryness, flaking) over the past 24 hours, throughout the trial.

Participants will receive investigational medication (active study drug) or placebo, via a cream. Study medication and study-related procedures will be provided at no cost. Reimbursement for study-related expenses will also be provided.

Study participation will last about 22 weeks and involve about 9 visits to the study centre.


Official Title

A Phase 3 Clinical Trial to Confirm Efficacy and Evaluate Safety of Twice-daily Delgocitinib Cream 20 mg/g Compared With Cream Vehicle for a 16-week Treatment Period in Adult Subjects With Moderate to Severe Chronic Hand Eczema (DELTA 1)

ClinicalTrials.gov ID

NCT04871711

Sponsor

LEO Pharma

Study Description

  • Brief Summary:

    LEO Pharma

  • Condition or Disease:

    Chronic Hand Eczema

  • Intervention/Treatment:

    Drug: Delgocitinib cream Drug: Cream vehicle
  • Phase:

    Phase 3

  • Ages Eligible for Study:

    18 Years and older (Adult,Older Adult)

  • Sexes Eligible for Study:

    All

Main inclusion criteria:

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).
HESD itch score (weekly average) of ≥4 points at baseline.
Participants who have a documented recent history of inadequate response to treatment with topical corticosteroids (TCS) or for whom TCS are documented to be otherwise medically inadvisable (e.g. due to important side effects or safety risks).
Participants adherent to standard non-medicated skin care including avoidance of known and relevant irritants and allergens.

Main exclusion criteria:

Concurrent skin diseases on the hands, e.g. tinea manuum.
Active atopic dermatitis requiring medical treatment in regions other than the hands and feet.
Active psoriasis on any part of the body.
Hyperkeratotic hand eczema in combination with a history of psoriasis on any part of the body.
Clinically significant infection on the hands.
Systemic treatment with immunosuppressive drugs, immunomodulating drugs, retinoids, or corticosteroids within 28 days prior to baseline.
Use of tanning beds, phototherapy, or bleach baths on the hands within 28 days prior to baseline.
Previous or current treatment with Janus kinase (JAK) inhibitors (including delgocitinib/LEO 124249), systemic or topical.
Cutaneously applied treatment with immunomodulators 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 transdermal or 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.

Treatment with any marketed biological therapy or investigational biologic agents:

Any cell-depleting agents: within 6 months prior to baseline, or until lymphocyte count returns to normal, whichever is longer.
Other biologics: within 3 months or 5 half-lives, whichever is longer, prior to baseline.
Clinically significant infection within 28 days prior to baseline which, in the opinion of the investigator, may compromise the safety of the participant in the trial, interfere with evaluation of the IMP, or reduce the participant’s ability to participate in the trial.
History of any known primary immunodeficiency disorder including a positive human immunodeficiency virus (HIV) test at screening, or the participant taking antiretroviral medications as determined by medical history and/or participant’s verbal report.

Any disorder which is not stable and could:

Affect the safety of the participant throughout the trial.
Impede the participant’s ability to complete the trial.
Positive hepatitis B surface antigen or hepatitis C virus antibody serology at screening.


Participating Locations


Participating Experts

Dr. Alim Devani

Dermatologist

Dr. Vimal Prajapati, MD, FRCPC, FAAD

Dermatologist

Dr. Darryl P. Toth, MD, FRCPC

Dermatologist

Dr. Maxwell Sauder

Dermatologist

Dr. Anatoli Freiman, MD, FRCPC, DABD

Dermatologist

Dr. Benjamin Barankin, MD, FRCPC

Dermatologist

Dr. Firouzeh Niakosari

Dermatologist

Dr. Charles Lynde MD, FRCPC

Dermatologist

Dr. Marnie Fisher

Dermatologist

Dr. Elena Poulos, MD, FAAD, DABD

Dermatologist

Dr. Melinda Gooderham, MSc, MD, FRCPC

Dermatologist

Dr. David N. Adam MD, FRCPC

Dermatologist

Dr. Irina Turchin, MD, FRCPC

Dermatologist

Dr. Chih-ho Hong, MD, FRCPC

Dermatologist

Dr. Susan Poelman

Dermatologist

Dr. Andrei Metelitsa, MD, FRCPC

Dermatologist

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