Topical Ruxolitinib Evaluation in Chronic Hand Eczema
Hand Eczema
About this trial
This is an interventional treatment trial for Hand Eczema focused on measuring eczema, chronic hand eczema (CHE), dermatitis, skin disease, JAK inhibitor
Eligibility Criteria
Inclusion Criteria: 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. 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.
Sites / Locations
- Southwest Skin Specialists Phoenix BiltmoreRecruiting
- First Oc DermatologyRecruiting
- Marvel Clinical Research LlcRecruiting
- Dermatology Research AssociatesRecruiting
- Skin Research of South Florida, Llc
- Well Pharma Medical Research CorporationRecruiting
- Forcare Clinical Research
- Midwest Allergy Sinus Asthma, Sc
- The Indiana Clinical Trials Center IctcRecruiting
- Delricht ResearchRecruiting
- Delricht ResearchRecruiting
- Henry Ford Medical Center
- Jubilee Clinical Research IncRecruiting
- Forest Hills Dermatology GroupRecruiting
- Juva Skin and Laser Center
- Onsite Clinical Solutions, Llc Charlotte Central OfficeRecruiting
- Bexley DermatologyRecruiting
- Central Sooner ResearchRecruiting
- Oregon Dermatology and Research CenterRecruiting
- Oregon Medical Research CenterRecruiting
- International Clinical Research Tennessee LlcRecruiting
- Austin Institute For Clinical Research Aicr Pflugerville
- Dermatology Clinical Research Center of San AntonioRecruiting
- Dermatology Research Institute Inc.
- Care Clinic
- Simcomed Health LtdRecruiting
- Fachklinik Bad Bentheim Dermatologie
- Derma-Study-Center Fn Gmbh
- Gemeinschaftspraxis Dr. Scholz, Dr. Sebastian
- Beldio Research Gmbh
- Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp. Z O.O.
- Centrum Badan Klinicznych Pi-House Sp. Z O.O.
- Laser Clinic S.C.
- Twoja Przychodnia - Szczecinskie Centrum Medyczne
- Klinika Ambroziak Estederm
- Dermmedica Sp. Z O.O.
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Ruxolitinib
Vehicle
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.
Vehicle cream for 16 weeks followed by crossover to ruxolitinib cream 1.5% BID in a 16-week treatment extension period.