Topical Ruxolitinib Evaluation in Chronic Hand Eczema Stu... | NCT05219864

Status Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ruxolitinib	Experimental	Ruxolitinib cream 1.5% twice daily (BID) for 16 weeks followed by ruxolitinib cream 1.5% BID for an additional 16-week treatment extension period.	Drug: Ruxolitinib cream
Vehicle	Placebo Comparator	Vehicle cream for 16 weeks followed by crossover to ruxolitinib cream 1.5% BID in a 16-week treatment extension period.	Drug: Vehicle

Name	Type	Description	Arm Group Labels	Other Names
Ruxolitinib cream	Drug	Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.	Ruxolitinib

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportion of participants achieving Investigator's Global Assessment-Chronic Hand Eczema Treatment Success (IGA-CHE-TS)	The Investigator's Global Assessment for chronic hand eczema (IGA-CHE) is an instrument used in clinical trials to rate the severity of the participant's global chronic hand eczema (CHE) and is based on a 5-point scale ranging from 0 (clear) to 4 (severe). IGA-CHE treatment success (IGA-CHE TS) is defined as an IGA-CHE score of 0 (clear) or 1 (almost clear) with a ≥2-step improvement from baseline.	Week 16

Secondary Outcomes

Measure	Description	Time Frame
Proportion of participants with a ≥ 4-point improvement in chronic hand eczema (CHE) related Itch NRS score	The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity and subject will rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable) on a daily basis.	Week 16

Eligibility Module

Eligibility Criteria

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.
Recent history (within the past 1 year of baseline) of inadequate response to treatment with topical corticosteroids (TCS), topical calcineurin inhibitors (TCI), or oral alitretinoin; or intolerance or contraindication to TCS or TCI or oral alitretinoin.
Willingness to avoid pregnancy or fathering children based on the criteria below.

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.
Participants who have an unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the investigator in the 4 weeks prior to baseline.
Participants with concurrent conditions and history of other diseases such as other active skin disease or infection on the hands; immunocompromised; chronic or acute infection requiring systemic treatments; active acute skin infection; other concomitant skin conditions that may interfere with study assessments or compromise participant safety; other types of eczema; chronic asthma requiring high dose of inhaled corticosteroids; current or history of hepatitis B or C virus infection.
Any serious illness or medical, physical, or psychiatric condition(s) that, in the investigator's opinion, would interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
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.
Further exclusion criteria apply.

Facility	Status	City	State	ZIP	Country	Contacts
Southwest Skin Specialists Phoenix Biltmore		Phoenix	Arizona	85018	United States
Raoof Md Encino

ID	Term
D004485	Eczema
D003872	Dermatitis
D012871	Skin Diseases

ID	Term
D017437	Skin and Connective Tissue Diseases
D017443	Skin Diseases, Eczematous