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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-502827-23-00 | Registry Identifier | EU CT Number |
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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).
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| 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. |
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| Vehicle | Placebo Comparator | Vehicle cream for 16 weeks followed by crossover to ruxolitinib cream 1.5% BID in a 16-week treatment extension period. |
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| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Investigator's Global Assessment-Chronic Hand Eczema Treatment Success (IGA-CHE-TS) at 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 CHE and is based on a 5-point scale ranging from 0 (clear) to 4 (severe) (1, almost clear; 2, mild eczema; 3, moderate eczema). IGA-CHE TS is defined as an IGA-CHE score of 0 (clear) or 1 (almost clear) with a ≥2-step improvement from Baseline. | Baseline; Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving ITCH4 Response at Weeks 4 and 16 | ITCH4 response was defined as a ≥4-point improvement in CHE-related Itch Numerical Rating Scale (NRS) score from Baseline. The CHE-related Itch NRS is a once-per-24 hours ("daily") participant-reported measure of the worst itch severity of their CHE assessed using an 11-point scale (0=no itch to 10=worst imaginable itch). | Baseline; Weeks 4 and 16 |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined Inclusion/Exclusion Criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Incyte Medical Monitor | Incyte Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southwest Skin Specialists Phoenix Biltmore | Phoenix | Arizona | 85018 | United States | ||
| First Oc Dermatology |
Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
This study was conducted at 30 study centers in Canada, Germany, Poland, and the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Participants applied ruxolitinib 1.5% cream twice daily (BID) to chronic hand eczema (CHE) lesions on the hands and wrists (if applicable) for 16 weeks. Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week OLE Period. Participants who applied ruxolitinib 1.5% cream BID during the DBVC Period continued to apply ruxolitinib 1.5% cream BID as needed for an additional 16 weeks in the OLE Period. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| 16-Week DBVC Period |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 19, 2023 | Jul 14, 2025 |
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Participants will receive ruxolitinib cream (1.5%) or vehicle cream for 16 weeks, after which they will be offered the opportunity to receive ruxilitinib cream (1.5%) in the open-label treatment extension period for another 16 weeks.
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| Vehicle | Drug | Vehicle cream is a topical formulation applied as a thin film to affected areas. |
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| Percentage of Participants Achieving ITCH4 Response at Day 3 and Week 1 (Day 7) | ITCH4 response was defined as a ≥4-point improvement in CHE-related Itch Numerical Rating Scale (NRS) score from Baseline. The CHE-related Itch NRS is a once-per-24 hours ("daily") participant-reported measure of the worst itch severity of their CHE assessed using an 11-point scale (0=no itch to 10=worst imaginable itch). | Baseline; Day 3; Week 1 (Day 7) |
| Percentage of Participants With Investigator's Global Assessment-Chronic Hand Eczema Treatment Success (IGA-CHE-TS) at Each Post-Baseline Visit | The IGA-CHE is an instrument used to rate the severity of the participant's global CHE and is based on a 5-point scale ranging from 0 (clear) to 4 (severe) (1, almost clear; 2, mild eczema; 3, moderate eczema). IGA-CHE TS is defined as an IGA-CHE score of 0 (clear) or 1 (almost clear) with a ≥2-step improvement from Baseline. | Baseline; Weeks 2, 4, 8, 12, 16, 24, and 32 |
| Change From Baseline in CHE-related Itch NRS Score at Each Post-Baseline Visit | The CHE-related Itch NRS is a once-per-24 hours ("daily") participant-reported measure of the worst itch severity of their CHE assessed using an 11-point scale (0=no itch to 10=worst imaginable itch). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Baseline; Weeks 1-32 |
| Time to ≥4-point Improvement From Baseline in CHE-related Itch NRS Score | ITCH4 response was defined as a ≥4-point improvement in CHE-related Itch Numerical Rating Scale (NRS) score from Baseline. The CHE-related Itch NRS is a once-per-24 hours ("daily") participant-reported measure of the worst itch severity of their CHE assessed using an 11-point scale (0=no itch to 10=worst imaginable itch). | Baseline; up to Week 32 |
| Change From Baseline in CHE-related Pain NRS Score at Each Post-Baseline Visit | The CHE-related Pain NRS is a once-per-24 hours ("daily") participant-reported measure of the worst pain severity of their CHE assessed using an 11-point scale (0=no pain to 10=worst imaginable pain). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Baseline; Weeks 1-32 |
| Percentage of Participants Achieving ≥2-point Improvement in CHE-related Skin Pain NRS Score From Baseline to Week 16 | The CHE-related Pain NRS is a once-per-24 hours ("daily") participant-reported measure of the worst pain severity of their CHE assessed using an 11-point scale (0=no pain to 10=worst imaginable pain). | Baseline; up to Week 16 |
| Time to ≥2-point Improvement From Baseline in CHE-related Skin Pain NRS Score | The CHE-related Pain NRS is a once-per-24 hours ("daily") participant-reported measure of the worst pain severity of their CHE assessed using an 11-point scale (0=no pain to 10=worst imaginable pain). | Baseline; up to Week 32 |
| Percentage Change in Hand Eczema Severity Index (HECSI) Score From Baseline to Week 16 | The HECSI divides the hand into 5 areas for assessment (fingertips, fingers [except the tips], palms, back of hands, and wrists). Each of the 5 areas of the hand are assessed separately for erythema, induration/papulation, vesicles, fissuring, scaling, and edema using the following scale: 0, no skin changes; 1, mild disease; 2, moderate disease; and 3, severe disease. To determine the HECSI score, the affected area for each location (total of both hands) is given a score from 0 to 4 (0, 0%; 1, 1%-25%; 2, 26%-50%; 3, 51%-75%; and 4, 76%-100%) based on the extent of clinical symptoms. Finally, the score given for the extent at each location is multiplied by the total sum of the intensity of each clinical feature to calculate the total HECSI score, varying from 0 to a maximum severity score of 360 points. Percentage change was calculated as the ([post-Baseline value minus the Baseline value]/[Baseline value]) * 100. | Baseline; up to Week 16 |
| Patient Global Impression of Change (PGIC) Score at Each Post-Baseline Visit | The PGIC is a participants' self-reporting measure that reflects their belief about the efficacy of treatment. The PGIC is a 7-point scale depicting a participant's rating of overall improvement of CHE. Participants were asked to select 1 response from the response options that best described the overall change in their CHE since they started study treatment: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse, and 7, very much worse. | Baseline; up to Week 32 |
| Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Weeks 2, 4, 8, 12, 16, 24, and 32 | The DLQI is a simple, 10-question validated questionnaire to measure how much the skin problem has affected the participant over the previous 7 days. The questionnaire was analyzed under 6 subscales as follows: symptoms and feelings (Questions 1 and 2); daily activities (Questions 3 and 4); leisure (Questions 5 and 6); work and school (Question 7); personal relations (Questions 8 and 9); and treatment (Question 10). Scoring of each question is as follows: very much = 3; a lot = 2; a little = 1; not at all = 0; not relevant = 0 (Question 7: "Prevented work or studying" = Yes = 3). The DLQI was calculated by summing the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life was impaired. | Baseline; up to Week 32 |
| Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 | The EQ-5D-5L questionnaire is a standardized, validated instrument for use as a measure of health outcome. The EQ-5D-5L questionnaire consists of the following 2 sections: the EQ-5D descriptive system and the EQ Visual Analog Scale (VAS). 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. The EQ VAS records the participant's self-rated health on a vertical VAS (0-100), where the endpoints are labeled "the best health you can imagine" (100 score) and "the worst health you can imagine" (0 score). | Baseline; up to Week 32 |
| Change From Baseline in EQ-5D-5L Visual Analog Scale (VAS) Score at Weeks 2, 4, 8, 12, 16, 24, and 32 | The EQ-5D-5L questionnaire is a standardized, validated instrument for use as a measure of health outcome. The EQ-5D-5L questionnaire consists of the following 2 sections: the EQ-5D descriptive system and the EQ Visual Analog Scale (VAS). 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. The EQ VAS records the participant's self-rated health on a vertical VAS (0-100), where the endpoints are labeled "the best health you can imagine" (100 score) and "the worst health you can imagine" (0 score). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Baseline; up to Week 32 |
| Change From Baseline in Quality of Life in Hand Eczema Questionnaire (QOLHEQ) Total Score at Weeks 2, 4, 8, 12, 16, 24, 32, and Follow-up | The QOLHEQ is a validated disease-specific instrument to assess disease-specific health-related quality of life in participants suffering from CHE over the past 7 days. It consists of 30 items that are summarized according to impairments for 4 subscales: symptoms, emotions, limitations in functioning, and treatment and prevention. Each item is scored on a scale of never, rarely, sometimes, often, and all the time. The overall score is calculated by summing all items and ranges from 0 to 117. Higher scores indicate a greater impact on quality of life. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Baseline; up to Week 36 |
| Change From Baseline in Work Productivity and Activity Impairment Questionnaire v2.0 in Chronic Hand Dermatitis (WPAI-ChHD) Score at Weeks 2, 4, 8, 12, 16, 24, 32, and Follow-up | The WPAI-ChHD questionnaire is a patient-reported quantitative assessment of the amount of absenteeism (measured as percentage of work time missed [PWTM] due to CHE), presentism, and daily activity impairment (percentage of impairment while working [PIWW] due to CHE, percentage of overall work impairment [POWI] due to CHE, percentage of activity impairment [PAI] due to CHE) attributable to a specific health problem. The WPAI-ChHD is a 6-item questionnaire used to assess the impact of chronic hand dermatitis (ChHD, the same as CHE in this context) on job performance and productivity in the last 7 days. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity. Scores range from 0% (no impairment) to 100% (complete impairment). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Baseline; up to Week 36 |
| Number of Participants With Any Treatment-emergent Adverse Event (TEAE) in the DBVC Period | An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until the end of the safety follow-up. | up to Week 16 |
| Number of Participants With Any ≥Grade 3 TEAE in the DBVC Period | A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until the end of the safety follow-up. The severity of AEs was based on the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 using Grades 1 through 5. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal. | up to Week 16 |
| Number of Participants With Any TEAE in the OLE Period | An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until the end of the safety follow-up. | up to Week 36 |
| Number of Participants With Any ≥Grade 3 TEAE in the OLE Period | A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until the end of the safety follow-up. The severity of AEs was based on the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 using Grades 1 through 5. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal. | up to Week 36 |
| Number of Participants With Clinically Meaningful Changes or Trends in Laboratory (Hematology and Serum Chemistry) Parameters or Vital Signs in the DBVC Period | The investigator determined whether a change was clinically meaningful. | up to Week 16 |
| Number of Participants With Clinically Meaningful Changes or Trends in Laboratory (Hematology and Serum Chemistry) Parameters or Vital Signs in the OLE Period | The investigator determined whether a change was clinically meaningful. | up to Week 36 |
| Fountain Valley |
| California |
| 92708 |
| United States |
| Marvel Clinical Research Llc | Huntington Beach | California | 92647 | United States |
| Dermatology Research Associates | Los Angeles | California | 90045 | United States |
| Skin Research of South Florida, Llc | Miami | Florida | 33173 | United States |
| Well Pharma Medical Research Corporation | Miami | Florida | 33173 | United States |
| Forcare Clinical Research | Tampa | Florida | 33613 | United States |
| Midwest Allergy Sinus Asthma, Sc | Normal | Illinois | 61761 | United States |
| The Indiana Clinical Trials Center Ictc | Plainfield | Indiana | 46168 | United States |
| Delricht Research | Baton Rouge | Louisiana | 70809 | United States |
| Delricht Research | New Orleans | Louisiana | 70115 | United States |
| Henry Ford Medical Center | Detroit | Michigan | 48084 | United States |
| Jubilee Clinical Research Inc | Las Vegas | Nevada | 89106 | United States |
| Forest Hills Dermatology Group | Kew Gardens | New York | 11415 | United States |
| Juva Skin and Laser Center | New York | New York | 10022 | United States |
| Onsite Clinical Solutions, Llc Charlotte Central Office | Charlotte | North Carolina | 28277 | United States |
| Bexley Dermatology | Bexley | Ohio | 43209 | United States |
| Central Sooner Research | Oklahoma City | Oklahoma | 73118 | United States |
| Oregon Dermatology and Research Center | Portland | Oregon | 97210 | United States |
| Oregon Medical Research Center | Portland | Oregon | 97223 | United States |
| International Clinical Research Tennessee Llc | Murfreesboro | Tennessee | 37130 | United States |
| Austin Institute For Clinical Research Aicr Pflugerville | Pflugerville | Texas | 78660 | United States |
| Dermatology Clinical Research Center of San Antonio | San Antonio | Texas | 78229 | United States |
| Dermatology Research Institute Inc. | Calgary | Alberta | T2J 7E1 | Canada |
| Care Clinic | Red Deer | Alberta | T4P-1K4 | Canada |
| Simcomed Health Ltd | Barrie | Ontario | L4M 1G7 | Canada |
| Fachklinik Bad Bentheim Dermatologie | Bad Bentheim | 48455 | Germany |
| Derma-Study-Center Fn Gmbh | Friedrichshafen | 88045 | Germany |
| Dermatologische Gemeinschaftspraxis Mahlow | Mahlow | 15831 | Germany |
| Beldio Research Gmbh | Memmingen | 87700 | Germany |
| Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp. Z O.O. | Elblag | 82-300 | Poland |
| Centrum Badan Klinicznych Pi-House Sp. Z O.O. | Gdansk | 80-546 | Poland |
| Laser Clinic S.C. | Szczecin | 70-332 | Poland |
| Twoja Przychodnia - Szczecinskie Centrum Medyczne | Szczecin | 71-434 | Poland |
| Klinika Ambroziak | Warsaw | 02-953 | Poland |
| Dermmedica Sp. Z O.O. | Wroclaw | 51-318 | Poland |
| FG001 | Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Participants applied matching vehicle cream BID to CHE lesions on the hands and wrists (if applicable) for 16 weeks. Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week OLE Period. Participants who applied vehicle cream BID during the DBVC Period applied ruxolitinib 1.5% cream BID as needed for 16 weeks in the OLE Period. |
| COMPLETED |
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| NOT COMPLETED |
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| 16-Week OLE Period |
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| ID | Title | Description |
|---|---|---|
| BG000 | Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Participants applied ruxolitinib 1.5% cream twice daily (BID) to chronic hand eczema (CHE) lesions on the hands and wrists (if applicable) for 16 weeks. Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week OLE Period. Participants who applied ruxolitinib 1.5% cream BID during the DBVC Period continued to apply ruxolitinib 1.5% cream BID as needed for an additional 16 weeks in the OLE Period. |
| BG001 | Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Participants applied matching vehicle cream BID to CHE lesions on the hands and wrists (if applicable) for 16 weeks. Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week OLE Period. Participants who applied vehicle cream BID during the DBVC Period applied ruxolitinib 1.5% cream BID as needed for 16 weeks in the OLE Period. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Percentage of Participants With Investigator's Global Assessment-Chronic Hand Eczema Treatment Success (IGA-CHE-TS) at 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 CHE and is based on a 5-point scale ranging from 0 (clear) to 4 (severe) (1, almost clear; 2, mild eczema; 3, moderate eczema). IGA-CHE TS is defined as an IGA-CHE score of 0 (clear) or 1 (almost clear) with a ≥2-step improvement from Baseline. | Intent-to-Treat (ITT) Population: all participants who were randomized to the study. Treatment groups were defined according to the treatment assignment at the time of randomization regardless of the actual study treatment the participant might have applied during their participation in the study. Missing post-Baseline values were imputed as nonresponders. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline; Week 16 |
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| Secondary | Percentage of Participants Achieving ITCH4 Response at Weeks 4 and 16 | ITCH4 response was defined as a ≥4-point improvement in CHE-related Itch Numerical Rating Scale (NRS) score from Baseline. The CHE-related Itch NRS is a once-per-24 hours ("daily") participant-reported measure of the worst itch severity of their CHE assessed using an 11-point scale (0=no itch to 10=worst imaginable itch). | ITT Population. Participants with a Baseline Itch NRS Score ≥4 were analyzed. Missing post-Baseline values were imputed as nonresponders at Weeks 4 and 16. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline; Weeks 4 and 16 |
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| Secondary | Percentage of Participants Achieving ITCH4 Response at Day 3 and Week 1 (Day 7) | ITCH4 response was defined as a ≥4-point improvement in CHE-related Itch Numerical Rating Scale (NRS) score from Baseline. The CHE-related Itch NRS is a once-per-24 hours ("daily") participant-reported measure of the worst itch severity of their CHE assessed using an 11-point scale (0=no itch to 10=worst imaginable itch). | ITT Population. Participants with a Baseline Itch NRS Score ≥4 were analyzed. Only participants with available data were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline; Day 3; Week 1 (Day 7) |
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| Secondary | Percentage of Participants With Investigator's Global Assessment-Chronic Hand Eczema Treatment Success (IGA-CHE-TS) at Each Post-Baseline Visit | The IGA-CHE is an instrument used to rate the severity of the participant's global CHE and is based on a 5-point scale ranging from 0 (clear) to 4 (severe) (1, almost clear; 2, mild eczema; 3, moderate eczema). IGA-CHE TS is defined as an IGA-CHE score of 0 (clear) or 1 (almost clear) with a ≥2-step improvement from Baseline. | ITT Population. Only participants with available data were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline; Weeks 2, 4, 8, 12, 16, 24, and 32 |
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| Secondary | Change From Baseline in CHE-related Itch NRS Score at Each Post-Baseline Visit | The CHE-related Itch NRS is a once-per-24 hours ("daily") participant-reported measure of the worst itch severity of their CHE assessed using an 11-point scale (0=no itch to 10=worst imaginable itch). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | ITT Population. Only participants with available data were analyzed. | Posted | Mean | Standard Deviation | scores on a scale | Baseline; Weeks 1-32 |
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| Secondary | Time to ≥4-point Improvement From Baseline in CHE-related Itch NRS Score | ITCH4 response was defined as a ≥4-point improvement in CHE-related Itch Numerical Rating Scale (NRS) score from Baseline. The CHE-related Itch NRS is a once-per-24 hours ("daily") participant-reported measure of the worst itch severity of their CHE assessed using an 11-point scale (0=no itch to 10=worst imaginable itch). | ITT Population. Participants with a Baseline Itch NRS Score ≥4 were analyzed. The 95% confidence interval was calculated based on the Brookmeyer and Crowley method. | Posted | Median | 95% Confidence Interval | days | Baseline; up to Week 32 |
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| Secondary | Change From Baseline in CHE-related Pain NRS Score at Each Post-Baseline Visit | The CHE-related Pain NRS is a once-per-24 hours ("daily") participant-reported measure of the worst pain severity of their CHE assessed using an 11-point scale (0=no pain to 10=worst imaginable pain). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | ITT Population. Only participants with available data were analyzed. | Posted | Mean | Standard Deviation | scores on a scale | Baseline; Weeks 1-32 |
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| Secondary | Percentage of Participants Achieving ≥2-point Improvement in CHE-related Skin Pain NRS Score From Baseline to Week 16 | The CHE-related Pain NRS is a once-per-24 hours ("daily") participant-reported measure of the worst pain severity of their CHE assessed using an 11-point scale (0=no pain to 10=worst imaginable pain). | ITT Population. Participants with a Baseline Pain NRS Score ≥2 were analyzed. Only participants with available data were analyzed. The 95% confidence interval was calculated using the method by Brookmeyer and Crowley. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline; up to Week 16 |
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| Secondary | Time to ≥2-point Improvement From Baseline in CHE-related Skin Pain NRS Score | The CHE-related Pain NRS is a once-per-24 hours ("daily") participant-reported measure of the worst pain severity of their CHE assessed using an 11-point scale (0=no pain to 10=worst imaginable pain). | ITT Population. Participants with a Baseline Pain NRS Score ≥2 were analyzed. The 95% confidence interval was calculated using the method by Brookmeyer and Crowley. | Posted | Median | 95% Confidence Interval | days | Baseline; up to Week 32 |
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| Secondary | Percentage Change in Hand Eczema Severity Index (HECSI) Score From Baseline to Week 16 | The HECSI divides the hand into 5 areas for assessment (fingertips, fingers [except the tips], palms, back of hands, and wrists). Each of the 5 areas of the hand are assessed separately for erythema, induration/papulation, vesicles, fissuring, scaling, and edema using the following scale: 0, no skin changes; 1, mild disease; 2, moderate disease; and 3, severe disease. To determine the HECSI score, the affected area for each location (total of both hands) is given a score from 0 to 4 (0, 0%; 1, 1%-25%; 2, 26%-50%; 3, 51%-75%; and 4, 76%-100%) based on the extent of clinical symptoms. Finally, the score given for the extent at each location is multiplied by the total sum of the intensity of each clinical feature to calculate the total HECSI score, varying from 0 to a maximum severity score of 360 points. Percentage change was calculated as the ([post-Baseline value minus the Baseline value]/[Baseline value]) * 100. | ITT Population. Only participants with available data were analyzed. | Posted | Mean | Standard Deviation | percentage change | Baseline; up to Week 16 |
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| Secondary | Patient Global Impression of Change (PGIC) Score at Each Post-Baseline Visit | The PGIC is a participants' self-reporting measure that reflects their belief about the efficacy of treatment. The PGIC is a 7-point scale depicting a participant's rating of overall improvement of CHE. Participants were asked to select 1 response from the response options that best described the overall change in their CHE since they started study treatment: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse, and 7, very much worse. | ITT Population. Only participants with available data were analyzed. | Posted | Mean | Standard Deviation | scores on a scale | Baseline; up to Week 32 |
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| Secondary | Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Weeks 2, 4, 8, 12, 16, 24, and 32 | The DLQI is a simple, 10-question validated questionnaire to measure how much the skin problem has affected the participant over the previous 7 days. The questionnaire was analyzed under 6 subscales as follows: symptoms and feelings (Questions 1 and 2); daily activities (Questions 3 and 4); leisure (Questions 5 and 6); work and school (Question 7); personal relations (Questions 8 and 9); and treatment (Question 10). Scoring of each question is as follows: very much = 3; a lot = 2; a little = 1; not at all = 0; not relevant = 0 (Question 7: "Prevented work or studying" = Yes = 3). The DLQI was calculated by summing the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life was impaired. | ITT Population. Only participants with available data were analyzed. | Posted | Mean | Standard Deviation | scores on a scale | Baseline; up to Week 32 |
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| Secondary | Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 | The EQ-5D-5L questionnaire is a standardized, validated instrument for use as a measure of health outcome. The EQ-5D-5L questionnaire consists of the following 2 sections: the EQ-5D descriptive system and the EQ Visual Analog Scale (VAS). 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. The EQ VAS records the participant's self-rated health on a vertical VAS (0-100), where the endpoints are labeled "the best health you can imagine" (100 score) and "the worst health you can imagine" (0 score). | ITT Population. Only participants with available data were analyzed. | Posted | Count of Participants | Participants | Baseline; up to Week 32 |
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| Secondary | Change From Baseline in EQ-5D-5L Visual Analog Scale (VAS) Score at Weeks 2, 4, 8, 12, 16, 24, and 32 | The EQ-5D-5L questionnaire is a standardized, validated instrument for use as a measure of health outcome. The EQ-5D-5L questionnaire consists of the following 2 sections: the EQ-5D descriptive system and the EQ Visual Analog Scale (VAS). 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. The EQ VAS records the participant's self-rated health on a vertical VAS (0-100), where the endpoints are labeled "the best health you can imagine" (100 score) and "the worst health you can imagine" (0 score). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | ITT Population. Only participants with available data were analyzed. | Posted | Mean | Standard Deviation | scores on a scale | Baseline; up to Week 32 |
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| Secondary | Change From Baseline in Quality of Life in Hand Eczema Questionnaire (QOLHEQ) Total Score at Weeks 2, 4, 8, 12, 16, 24, 32, and Follow-up | The QOLHEQ is a validated disease-specific instrument to assess disease-specific health-related quality of life in participants suffering from CHE over the past 7 days. It consists of 30 items that are summarized according to impairments for 4 subscales: symptoms, emotions, limitations in functioning, and treatment and prevention. Each item is scored on a scale of never, rarely, sometimes, often, and all the time. The overall score is calculated by summing all items and ranges from 0 to 117. Higher scores indicate a greater impact on quality of life. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | ITT Population. Only participants with available data were analyzed. | Posted | Mean | Standard Deviation | scores on a scale | Baseline; up to Week 36 |
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| Secondary | Change From Baseline in Work Productivity and Activity Impairment Questionnaire v2.0 in Chronic Hand Dermatitis (WPAI-ChHD) Score at Weeks 2, 4, 8, 12, 16, 24, 32, and Follow-up | The WPAI-ChHD questionnaire is a patient-reported quantitative assessment of the amount of absenteeism (measured as percentage of work time missed [PWTM] due to CHE), presentism, and daily activity impairment (percentage of impairment while working [PIWW] due to CHE, percentage of overall work impairment [POWI] due to CHE, percentage of activity impairment [PAI] due to CHE) attributable to a specific health problem. The WPAI-ChHD is a 6-item questionnaire used to assess the impact of chronic hand dermatitis (ChHD, the same as CHE in this context) on job performance and productivity in the last 7 days. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity. Scores range from 0% (no impairment) to 100% (complete impairment). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | ITT Population. Only participants with available data were analyzed. | Posted | Mean | Standard Deviation | percentage | Baseline; up to Week 36 |
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| Secondary | Number of Participants With Any Treatment-emergent Adverse Event (TEAE) in the DBVC Period | An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until the end of the safety follow-up. | Safety Population: all randomized participants who applied study treatment at least once. Treatment groups were determined according to the actual treatment the participant applied on Day 1 regardless of assigned study treatment. | Posted | Count of Participants | Participants | up to Week 16 |
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| Secondary | Number of Participants With Any ≥Grade 3 TEAE in the DBVC Period | A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until the end of the safety follow-up. The severity of AEs was based on the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 using Grades 1 through 5. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal. | Safety Population | Posted | Count of Participants | Participants | up to Week 16 |
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| Secondary | Number of Participants With Any TEAE in the OLE Period | An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until the end of the safety follow-up. | Open-label Evaluable Population: all participants who applied study treatment at least once during the OLE Period | Posted | Count of Participants | Participants | up to Week 36 |
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| Secondary | Number of Participants With Any ≥Grade 3 TEAE in the OLE Period | A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until the end of the safety follow-up. The severity of AEs was based on the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 using Grades 1 through 5. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal. | Open-label Evaluable Population | Posted | Count of Participants | Participants | up to Week 36 |
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| Secondary | Number of Participants With Clinically Meaningful Changes or Trends in Laboratory (Hematology and Serum Chemistry) Parameters or Vital Signs in the DBVC Period | The investigator determined whether a change was clinically meaningful. | Safety Population | Posted | Count of Participants | Participants | up to Week 16 |
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| Secondary | Number of Participants With Clinically Meaningful Changes or Trends in Laboratory (Hematology and Serum Chemistry) Parameters or Vital Signs in the OLE Period | The investigator determined whether a change was clinically meaningful. | Open-label Evaluable Population | Posted | Count of Participants | Participants | up to Week 36 |
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up to Week 36
For participants who were on vehicle up to Week 16 and then switched to ruxolitinib, AEs are presented by the treatment they were on at the onset of the event.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vehicle Cream BID | Participants applied matching vehicle cream twice daily (BID) to chronic hand eczema (CHE) lesions on the hands and wrists (if applicable) for 16 weeks. | 0 | 92 | 1 | 92 | 9 | 92 |
| EG001 | Ruxolitinib 1.5% Cream BID | Participants applied ruxolitinib 1.5% cream BID to CHE lesions on the hands and wrists (if applicable) for 16 weeks in the DBVC Period and for 16 weeks in the OLE Period. Participants who applied matching vehicle cream BID to CHE for 16 weeks during the DBVC Period and completed the Week 16 assessments with no safety concerns applied ruxolitinib 1.5% cream for 16 weeks during the OLE Period. | 1 | 171 | 5 | 171 | 10 | 171 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Brain neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
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| Cardiac arrest | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
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| Prostatic obstruction | Reproductive system and breast disorders | MedDRA 27.0 | Systematic Assessment |
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| Retinal artery embolism | Eye disorders | MedDRA 27.0 | Systematic Assessment |
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| Sinus node dysfunction | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study, provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Incyte Corporation | 1-855-463-3463 | medinfo@incyte.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 29, 2024 | Jul 14, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D004485 | Eczema |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| ID | Term |
|---|---|
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
Not provided
Not provided
| Protocol Violation |
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| Withdrawal by Subject |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Black/African American |
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| Asian |
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| Not Reported |
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| Indian |
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| Middle Eastern |
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| Response rate difference |
| 42.5 |
| Standard Error of the Mean |
| 6.03 |
| 2-Sided |
| 95 |
| 30.70 |
| 54.36 |
| Superiority |
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| OG001 | Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Participants applied matching vehicle cream BID to CHE lesions on the hands and wrists (if applicable) for 16 weeks. Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week OLE Period. Participants who applied vehicle cream BID during the DBVC Period applied ruxolitinib 1.5% cream BID as needed for 16 weeks in the OLE Period. |
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Participants applied matching vehicle cream BID to CHE lesions on the hands and wrists (if applicable) for 16 weeks. Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week OLE Period. Participants who applied vehicle cream BID during the DBVC Period applied ruxolitinib 1.5% cream BID as needed for 16 weeks in the OLE Period. |
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Participants applied matching vehicle cream BID to CHE lesions on the hands and wrists (if applicable) for 16 weeks. Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week OLE Period. Participants who applied vehicle cream BID during the DBVC Period applied ruxolitinib 1.5% cream BID as needed for 16 weeks in the OLE Period. |
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| OG001 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID |
Participants applied matching vehicle cream BID to CHE lesions on the hands and wrists (if applicable) for 16 weeks. Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week OLE Period. Participants who applied vehicle cream BID during the DBVC Period applied ruxolitinib 1.5% cream BID as needed for 16 weeks in the OLE Period. |
|
|
Participants applied matching vehicle cream BID to CHE lesions on the hands and wrists (if applicable) for 16 weeks. Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week OLE Period. Participants who applied vehicle cream BID during the DBVC Period applied ruxolitinib 1.5% cream BID as needed for 16 weeks in the OLE Period. |
|
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| OG001 | Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Participants applied matching vehicle cream BID to CHE lesions on the hands and wrists (if applicable) for 16 weeks. Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week OLE Period. Participants who applied vehicle cream BID during the DBVC Period applied ruxolitinib 1.5% cream BID as needed for 16 weeks in the OLE Period. |
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| Units | Counts |
|---|---|
| Participants |
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Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week OLE Period. Participants who applied vehicle cream BID during the DBVC Period applied ruxolitinib 1.5% cream BID as needed for 16 weeks in the OLE Period.
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