Adults aged 18 years or older with a diagnosis of chronic hand eczema (CHE) for 6 months or more are needed for this clinical research trial. Eligible participants must have hand eczema lasting for 3 months or more, or 2 or more reoccurences within the previous 12 months. Eligible participants must also have been treated with at least 1 prescription CHE therapy, unless such therapy was not advisable or contraindicated.
Participants will receive a treatment via a topical cream. Study treatment and study-related assessments will be provided at no cost. Reimbursement for study-related expenses may be provided.
Bexley - Bexley Dermatology Research
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Last Update Posted: September 24, 2023
NCT05906628
Incyte Corporation
Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of ruxolitinib cream in adult participants with diagnosis of chronic hand eczema (CHE) and moderate to severe disease activity (Investigator's Global Assessement (IGA) of CHE score 3 or 4).
Condition or Disease:
Hand Eczema
Intervention/Treatment:
Drug: Ruxolitinib creamPhase:
Phase 2
Ages Eligible for Study:
18 Years and older (Adult)
Sexes Eligible for Study:
All
Inclusion Criteria:
Diagnosis of chromic hand eczema (CHE) as defined by hand eczema (HE) lasting > 3 months or ≥ 2 flares within the previous 12 months.
Screening and baseline IGA-CHE 3 or 4.
Baseline CHE-related Itch NRS ≥ 4.
Have been treated with at least 1 prescription CHE therapy or if such therapy was not advisable or contraindicated.
Willingness to avoid pregnancy or fathering children based on the criteria defined in the protocol.
Exclusion Criteria:
Known triggers for CHE (allergic or irritant, such as those identified by previous patch tests) cannot be avoided during the course of this study.
Any serious illness or medical, physical, or psychiatric condition(s).
Laboratory values outside of the protocol-defined criteria.
Use of protocol-defined treatments within the indicated washout period before baseline.
Psoralen ultraviolet A (PUVA) or ultraviolet B (UVB) therapy on the hands within 4 weeks before baseline.
Pregnant or lactating participants, or those considering pregnancy during the period of their study participation.
Other protocol-defined Inclusion/Exclusion Criteria may apply.
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