Topical Ruxolitinib Evaluation in Chronic Hand Eczema
- Registration Number
- NCT05906628
- Lead Sponsor
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 186
- Diagnosis of CHE for at least 6 months prior to screening. 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vehicle Vehicle Vehicle cream for 16 weeks followed by crossover to ruxolitinib cream 1.5% BID in a 16-week treatment extension period. Ruxolitinib Ruxolitinib cream 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.
- Primary Outcome Measures
Name Time Method Proportion of participants achieving IGA-CHE-TS Week 16 The Investigator's Global Assessment-Chronic Hand Eczema (IGA-CHE) is an instrument used 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.
- Secondary Outcome Measures
Name Time Method Proportion of participants with a ≥ 4-point improvement in chronic hand eczema (CHE) related Itch Numerical Rating Scale (NRS) score Week 16 The Itch NRS is an instrument for measurement of intensity and participant will rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable).
Proportion of participants with a ≥ 4-point improvement in chronic hand eczema (CHE) related Itch NRS score Day 3 The Itch NRS is an instrument for measurement of intensity and participant will rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable).
Proportion of participants achieving an IGA-CHE-TS from baseline Up to Week 32 The Investigator's Global Assessment for chronic hand eczema (IGA-CHE) is an instrument used 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.
Change from baseline in CHE-related Itch NRS score Up to Week 32 The Itch NRS is an instrument for measurement of itch intensity and participant will rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable).
Time to ≥ 4-point improvement from baseline in CHE-related Itch NRS score Up to Week 32 The Itch NRS is an instrument for measurement of itch intensity and participant will rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable).
Change from baseline in CHE-related Skin Pain NRS score Up to Week 32 The Pain NRS is an instrument for measurement of pain intensity and participant will rate the intensity of their pain on an 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable).
Proportion of participants with a ≥ 2-point improvement in CHE-related Pain NRS score Week 16 The Pain NRS is an instrument for measurement of pain intensity and participant will rate the intensity of their pain on an 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable).
Time to ≥ 2-point improvement from baseline in CHE-related Pain NRS score Up to Week 32 The Pain NRS is an instrument for measurement of pain intensity and participant will rate the intensity of their pain on an 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable).
Percentage change from baseline in Hand Eczema Severity Index (HECSI) Week 16 The Hand Eczema Severity Index (HECSI) is an instrument used to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) and the extent of the lesions in each of the 5 hand regions (fingertips, fingers \[except fingertips\], palm of hands, back of hands, and wrists) by use of standard scales.
Proportion of participants with each score on the PGIC Up to Week 32 The PGIC is based on a 7-point scale and the participant will rate each question from the start of treatment as 1-very much improved, 2-much improved, 3-minimally improved, 4-no change, 5-minimally worse, 6-much worse, and 7-very much worse.
Change from baseline in DLQI score Up to week 32 The Dermatology Life Quality Index (DLQI) is a 10-question questionnaire to measure how much the skin problem has affected the participant over the previous 7 days and participant will rate each question as 1-very much, 2- a lot, 3-a little, or 4-not at all.
Change from baseline in EQ-5D-5L score Up to Week 32 The EQ-5D-5L questionnaire is a standardized, validated instrument for use as a measure of health outcome. The descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: Level 1 = no problems, Level 2 = slight problems, Level 3 = moderate problems, Level 4 = severe problems, and Level 5 = extreme problems.
Change from baseline in QOLHEQ score Up to week 32, followed by 30 days follow-up The Quality of Life in Hand Eczema Questionnaire (QOLHEQ) is a disease-specific instrument to assess disease-specific health-related quality of life in participants with CHE over the past 7 days. It consists of 30 items covering impairments in 4 domains: 1) symptoms, 2) emotions, 3) limitations in functioning, and 4) treatment and prevention. Each item is scored in a 5-point scale: 0) never, 1) rarely, 2) sometimes, 3) often, and 4) all the time.
Change from baseline in WPAI-ChHD Up to week 32, followed by 30 days follow-up The Work Productivity and Activity Impairment Questionnaire Specific Health Problem v2.0 in Chronic Hand Eczema (WPAI-ChHD) questionnaire is a 6-item questionnaire used to assess the impact of chronic hand dermatitis on job performance and productivity over the past 7 days.
Number of Participants with Treatment Emergent Adverse Events (TEAE) Up to week 32, followed by 30 days follow-up Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.
Trial Locations
- Locations (35)
First Oc Dermatology
🇺🇸Fountain Valley, California, United States
Skin Research of South Florida, Llc
🇺🇸Miami, Florida, United States
Dermatology Clinical Research Center of San Antonio
🇺🇸San Antonio, Texas, United States
Henry Ford Medical Center
🇺🇸Detroit, Michigan, United States
Austin Institute For Clinical Research Aicr Pflugerville
🇺🇸Pflugerville, Texas, United States
Southwest Skin Specialists Phoenix Biltmore
🇺🇸Phoenix, Arizona, United States
The Indiana Clinical Trials Center Ictc
🇺🇸Plainfield, Indiana, United States
Midwest Allergy Sinus Asthma, Sc
🇺🇸Normal, Illinois, United States
Juva Skin and Laser Center
🇺🇸New York, New York, United States
Central Sooner Research
🇺🇸Oklahoma City, Oklahoma, United States
Jubilee Clinical Research Inc
🇺🇸Las Vegas, Nevada, United States
Derma-Study-Center Fn Gmbh
🇩🇪Friedrichshafen, Germany
Dermatologische Gemeinschaftspraxis Mahlow
🇩🇪Mahlow, Germany
Care Clinic
🇨🇦Red Deer, Alberta, Canada
Simcomed Health Ltd
🇨🇦Barrie, Ontario, Canada
Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp. Z O.O.
🇵🇱Elblag, Poland
Fachklinik Bad Bentheim Dermatologie
🇩🇪Bad Bentheim, Germany
Klinika Ambroziak
🇵🇱Warszawa, Poland
Centrum Badan Klinicznych Pi-House Sp. Z O.O.
🇵🇱Gdansk, Poland
Laser Clinic S.C.
🇵🇱Szczecin, Poland
Twoja Przychodnia - Szczecinskie Centrum Medyczne
🇵🇱Szczecin, Poland
Dermmedica Sp. Z O.O.
🇵🇱Wroclaw, Poland
Marvel Clinical Research Llc
🇺🇸Huntington Beach, California, United States
Dermatology Research Associates
🇺🇸Los Angeles, California, United States
Forcare Clinical Research
🇺🇸Tampa, Florida, United States
Bexley Dermatology
🇺🇸Bexley, Ohio, United States
Forest Hills Dermatology Group
🇺🇸Kew Gardens, New York, United States
Well Pharma Medical Research Corporation
🇺🇸Miami, Florida, United States
Onsite Clinical Solutions, Llc Charlotte Central Office
🇺🇸Charlotte, North Carolina, United States
International Clinical Research Tennessee Llc
🇺🇸Murfreesboro, Tennessee, United States
Dermatology Research Institute Inc.
🇨🇦Calgary, Alberta, Canada
Beldio Research Gmbh
🇩🇪Memmingen, Germany
Delricht Research
🇺🇸New Orleans, Louisiana, United States
Oregon Dermatology and Research Center
🇺🇸Portland, Oregon, United States
Oregon Medical Research Center
🇺🇸Portland, Oregon, United States