Efficacy and Safety of Delgocitinib Cream in Adults With Moderate to Severe Chronic Hand Eczema (NCT04871711) | Clinical Trial Compass
CompletedPhase 3
Efficacy and Safety of Delgocitinib Cream in Adults With Moderate to Severe Chronic Hand Eczema
Canada487 participantsStarted 2021-05-10
Plain-language summary
This was a 16-week study in adult participants with chronic hand eczema (CHE). \> The participants visited the clinic regularly to have the study doctor assess their CHE and to answer questions about itch, pain, CHE symptoms, and quality of life.
\> The purpose was to assess how delgocitinib cream works to treat CHE when compared to a placebo cream with no active substance.
Who can participate
Age range18 Years
SexALL
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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 Investigator's Global Assessment for chronic hand eczema (IGA-CHE) (i.e. an IGA-CHE score of 3 or 4).
* Hand Eczema Symptom Diary (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 (incl…