| Primary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | 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 be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study cream. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first application of study cream and up to 30 days after the last application of study cream. | Full Analysis Set: all participants who applied ruxolitinib cream at least once | Posted | | Count of Participants | | Participants | | up to 462 days | | | | ID | Title | Description |
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| OG000 | Ruxolitinib 1.5% Cream BID | Participants applied ruxolitinib 1.5% cream twice daily (BID) to all areas identified for treatment at Baseline regardless of whether or not the lesion(s) improved for 8 weeks (Continuous Treatment Period). Participants who completed the Week 8 assessments with no safety concerns and with a percentage of body surface area (%BSA) affected by atopic dermatitis of no greater than 20% continued into the Long-term Safety (LTS) Period. During the 44 weeks of the LTS Period, the treatment regimen continued to be ruxolitinib 1.5% cream BID; however, participants only treated active atopic dermatitis lesions. |
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| Primary | Number of Participants With ≥Grade 3 TEAEs | An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was drug related. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first application of study cream and up to 30 days after the last application of study cream. The severity of AEs was assessed using Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0) 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. | | Posted | | Count of Participants | | Participants | | up to 462 days | | | | ID | Title | Description |
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| OG000 | Ruxolitinib 1.5% Cream BID | Participants applied ruxolitinib 1.5% cream twice daily (BID) to all areas identified for treatment at Baseline regardless of whether or not the lesion(s) improved for 8 weeks (Continuous Treatment Period). Participants who completed the Week 8 assessments with no safety concerns and with a percentage of body surface area (%BSA) affected by atopic dermatitis of no greater than 20% continued into the Long-term Safety (LTS) Period. During the 44 weeks of the LTS Period, the treatment regimen continued to be ruxolitinib 1.5% cream BID; however, participants only treated active atopic dermatitis lesions. |
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| Secondary | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing | Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils, and platelets were measured in 10^9 cells per liter. | | Posted | | Count of Participants | | Participants | | up to Week 8 | | | | ID | Title | Description |
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| OG000 | Ruxolitinib 1.5% Cream BID | Participants applied ruxolitinib 1.5% cream twice daily (BID) to all areas identified for treatment at Baseline regardless of whether or not the lesion(s) improved for 8 weeks (Continuous Treatment Period). Participants who completed the Week 8 assessments with no safety concerns and with a percentage of body surface area (%BSA) affected by atopic dermatitis of no greater than 20% continued into the Long-term Safety (LTS) Period. During the 44 weeks of the LTS Period, the treatment regimen continued to be ruxolitinib 1.5% cream BID; however, participants only treated active atopic dermatitis lesions. |
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| Secondary | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing | Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Basophils (baso)/leukocytes (leuk), eosinophils (eosino)/leukocytes, lymphocytes/leukocytes, monocytes/leukocytes, and neutrophils (neutro)/leukocytes were measured as a percentage. | | Posted | | Count of Participants | | Participants | | up to Week 8 | | | | ID | Title | Description |
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| OG000 | Ruxolitinib 1.5% Cream BID | Participants applied ruxolitinib 1.5% cream twice daily (BID) to all areas identified for treatment at Baseline regardless of whether or not the lesion(s) improved for 8 weeks (Continuous Treatment Period). Participants who completed the Week 8 assessments with no safety concerns and with a percentage of body surface area (%BSA) affected by atopic dermatitis of no greater than 20% continued into the Long-term Safety (LTS) Period. During the 44 weeks of the LTS Period, the treatment regimen continued to be ruxolitinib 1.5% cream BID; however, participants only treated active atopic dermatitis lesions. |
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| Secondary | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Erythrocyte Mean Corpuscular Volume and Mean Platelet Volume Value of Low, Normal, High, Low and High, and Missing | Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Erythrocyte mean corpuscular volume and mean platelet volume were measured in femtoliters. | | Posted | | Count of Participants | | Participants | | up to Week 8 | | | | ID | Title | Description |
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| OG000 | Ruxolitinib 1.5% Cream BID | Participants applied ruxolitinib 1.5% cream twice daily (BID) to all areas identified for treatment at Baseline regardless of whether or not the lesion(s) improved for 8 weeks (Continuous Treatment Period). Participants who completed the Week 8 assessments with no safety concerns and with a percentage of body surface area (%BSA) affected by atopic dermatitis of no greater than 20% continued into the Long-term Safety (LTS) Period. During the 44 weeks of the LTS Period, the treatment regimen continued to be ruxolitinib 1.5% cream BID; however, participants only treated active atopic dermatitis lesions. |
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| Secondary | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Erythrocyte Value of Low, Normal, High, Low and High, and Missing | Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Erythrocytes were measured in 10^12/Liter. | | Posted | | Count of Participants | | Participants | | up to Week 8 | | | | ID | Title | Description |
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| OG000 | Ruxolitinib 1.5% Cream BID | Participants applied ruxolitinib 1.5% cream twice daily (BID) to all areas identified for treatment at Baseline regardless of whether or not the lesion(s) improved for 8 weeks (Continuous Treatment Period). Participants who completed the Week 8 assessments with no safety concerns and with a percentage of body surface area (%BSA) affected by atopic dermatitis of no greater than 20% continued into the Long-term Safety (LTS) Period. During the 44 weeks of the LTS Period, the treatment regimen continued to be ruxolitinib 1.5% cream BID; however, participants only treated active atopic dermatitis lesions. |
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| Secondary | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Hematocrit Value of Low, Normal, High, Low and High, and Missing | Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Hematocrit was measured in liters of red blood cells per liter of blood (L/L). | | Posted | | Count of Participants | | Participants | | up to Week 8 | | | | ID | Title | Description |
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| OG000 | Ruxolitinib 1.5% Cream BID | Participants applied ruxolitinib 1.5% cream twice daily (BID) to all areas identified for treatment at Baseline regardless of whether or not the lesion(s) improved for 8 weeks (Continuous Treatment Period). Participants who completed the Week 8 assessments with no safety concerns and with a percentage of body surface area (%BSA) affected by atopic dermatitis of no greater than 20% continued into the Long-term Safety (LTS) Period. During the 44 weeks of the LTS Period, the treatment regimen continued to be ruxolitinib 1.5% cream BID; however, participants only treated active atopic dermatitis lesions. |
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| Secondary | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Hemoglobin Value of Low, Normal, High, Low and High, and Missing | Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Hemoglobin was measured in grams per liter. | | Posted | | Count of Participants | | Participants | | up to Week 8 | | | | ID | Title | Description |
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| OG000 | Ruxolitinib 1.5% Cream BID | Participants applied ruxolitinib 1.5% cream twice daily (BID) to all areas identified for treatment at Baseline regardless of whether or not the lesion(s) improved for 8 weeks (Continuous Treatment Period). Participants who completed the Week 8 assessments with no safety concerns and with a percentage of body surface area (%BSA) affected by atopic dermatitis of no greater than 20% continued into the Long-term Safety (LTS) Period. During the 44 weeks of the LTS Period, the treatment regimen continued to be ruxolitinib 1.5% cream BID; however, participants only treated active atopic dermatitis lesions. |
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| Secondary | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing | Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils, and platelets were measured in 10^9 cells per liter. | Long-term Safety (LTS) Evaluable Population: all participants who applied ruxolitinib cream at least once during the LTS Period | Posted | | Count of Participants | | Participants | | from Week 9 up to Week 52 (44 weeks) | | | | ID | Title | Description |
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| OG000 | Ruxolitinib 1.5% Cream BID | Participants applied ruxolitinib 1.5% cream twice daily (BID) to all areas identified for treatment at Baseline regardless of whether or not the lesion(s) improved for 8 weeks (Continuous Treatment Period). Participants who completed the Week 8 assessments with no safety concerns and with a percentage of body surface area (%BSA) affected by atopic dermatitis of no greater than 20% continued into the Long-term Safety (LTS) Period. During the 44 weeks of the LTS Period, the treatment regimen continued to be ruxolitinib 1.5% cream BID; however, participants only treated active atopic dermatitis lesions. |
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| Secondary | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing | Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Basophils (baso)/leukocytes (leuko), eosinophils (eosino)/leukocytes, lymphocytes/leukocytes, monocytes/leukocytes, and neutrophils (neutro)/leukocytes were measured as a percentage. | | Posted | | Count of Participants | | Participants | | from Week 9 up to Week 52 (44 weeks) | | | | ID | Title | Description |
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| OG000 | Ruxolitinib 1.5% Cream BID | Participants applied ruxolitinib 1.5% cream twice daily (BID) to all areas identified for treatment at Baseline regardless of whether or not the lesion(s) improved for 8 weeks (Continuous Treatment Period). Participants who completed the Week 8 assessments with no safety concerns and with a percentage of body surface area (%BSA) affected by atopic dermatitis of no greater than 20% continued into the Long-term Safety (LTS) Period. During the 44 weeks of the LTS Period, the treatment regimen continued to be ruxolitinib 1.5% cream BID; however, participants only treated active atopic dermatitis lesions. |
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| Secondary | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Erythrocyte Mean Corpuscular Volume and Mean Platelet Volume Value of Low, Normal, High, Low and High, and Missing | Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Erythrocyte mean corpuscular volume and mean platelet volume were measured in femtoliters. | | Posted | | Count of Participants | | Participants | | from Week 9 up to Week 52 (44 weeks) | | | | ID | Title | Description |
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| OG000 | Ruxolitinib 1.5% Cream BID | Participants applied ruxolitinib 1.5% cream twice daily (BID) to all areas identified for treatment at Baseline regardless of whether or not the lesion(s) improved for 8 weeks (Continuous Treatment Period). Participants who completed the Week 8 assessments with no safety concerns and with a percentage of body surface area (%BSA) affected by atopic dermatitis of no greater than 20% continued into the Long-term Safety (LTS) Period. During the 44 weeks of the LTS Period, the treatment regimen continued to be ruxolitinib 1.5% cream BID; however, participants only treated active atopic dermatitis lesions. |
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| Secondary | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Erythrocyte Value of Low, Normal, High, Low and High, and Missing | Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Erythrocytes were measured in 10^12/Liter. | | Posted | | Count of Participants | | Participants | | from Week 9 up to Week 52 (44 weeks) | | | | ID | Title | Description |
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| OG000 | Ruxolitinib 1.5% Cream BID | Participants applied ruxolitinib 1.5% cream twice daily (BID) to all areas identified for treatment at Baseline regardless of whether or not the lesion(s) improved for 8 weeks (Continuous Treatment Period). Participants who completed the Week 8 assessments with no safety concerns and with a percentage of body surface area (%BSA) affected by atopic dermatitis of no greater than 20% continued into the Long-term Safety (LTS) Period. During the 44 weeks of the LTS Period, the treatment regimen continued to be ruxolitinib 1.5% cream BID; however, participants only treated active atopic dermatitis lesions. |
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| Secondary | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Hematocrit Value of Low, Normal, High, Low and High, and Missing | Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Hematocrit was measured in liters of red blood cells per liter of blood (L/L). | | Posted | | Count of Participants | | Participants | | from Week 9 up to Week 52 (44 weeks) | | | | ID | Title | Description |
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| OG000 | Ruxolitinib 1.5% Cream BID | Participants applied ruxolitinib 1.5% cream twice daily (BID) to all areas identified for treatment at Baseline regardless of whether or not the lesion(s) improved for 8 weeks (Continuous Treatment Period). Participants who completed the Week 8 assessments with no safety concerns and with a percentage of body surface area (%BSA) affected by atopic dermatitis of no greater than 20% continued into the Long-term Safety (LTS) Period. During the 44 weeks of the LTS Period, the treatment regimen continued to be ruxolitinib 1.5% cream BID; however, participants only treated active atopic dermatitis lesions. |
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| Secondary | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Hemoglobin Value of Low, Normal, High, Low and High, and Missing | Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Hemoglobin was measured in grams per liter. | | Posted | | Count of Participants | | Participants | | from Week 9 up to Week 52 (44 weeks) | | | | ID | Title | Description |
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| OG000 | Ruxolitinib 1.5% Cream BID | Participants applied ruxolitinib 1.5% cream twice daily (BID) to all areas identified for treatment at Baseline regardless of whether or not the lesion(s) improved for 8 weeks (Continuous Treatment Period). Participants who completed the Week 8 assessments with no safety concerns and with a percentage of body surface area (%BSA) affected by atopic dermatitis of no greater than 20% continued into the Long-term Safety (LTS) Period. During the 44 weeks of the LTS Period, the treatment regimen continued to be ruxolitinib 1.5% cream BID; however, participants only treated active atopic dermatitis lesions. |
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| Secondary | CT Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing | Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Alanine aminotransferase (ALT), alkaline phosphatase (ALP), aspartate aminotransferase (AST), creatine kinase (CK), and lactate dehydrogenase (LDH) were measured in units per liter. | | Posted | | Count of Participants | | Participants | | up to Week 8 | | | | ID | Title | Description |
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| OG000 | Ruxolitinib 1.5% Cream BID | Participants applied ruxolitinib 1.5% cream twice daily (BID) to all areas identified for treatment at Baseline regardless of whether or not the lesion(s) improved for 8 weeks (Continuous Treatment Period). Participants who completed the Week 8 assessments with no safety concerns and with a percentage of body surface area (%BSA) affected by atopic dermatitis of no greater than 20% continued into the Long-term Safety (LTS) Period. During the 44 weeks of the LTS Period, the treatment regimen continued to be ruxolitinib 1.5% cream BID; however, participants only treated active atopic dermatitis lesions. |
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| Secondary | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Albumin Value of Low, Normal, High, Low and High, and Missing | Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Albumin was measured in grams per liter. | | Posted | | Count of Participants | | Participants | | up to Week 8 | | | | ID | Title | Description |
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| OG000 | Ruxolitinib 1.5% Cream BID | Participants applied ruxolitinib 1.5% cream twice daily (BID) to all areas identified for treatment at Baseline regardless of whether or not the lesion(s) improved for 8 weeks (Continuous Treatment Period). Participants who completed the Week 8 assessments with no safety concerns and with a percentage of body surface area (%BSA) affected by atopic dermatitis of no greater than 20% continued into the Long-term Safety (LTS) Period. During the 44 weeks of the LTS Period, the treatment regimen continued to be ruxolitinib 1.5% cream BID; however, participants only treated active atopic dermatitis lesions. |
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| Secondary | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Bilirubin, Creatinine, and Direct Bilirubin Value of Low, Normal, High, Low and High, and Missing | Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Bilirubin, creatinine, and direct bilirubin were measured in micromoles per liter (µmol/L). | | Posted | | Count of Participants | | Participants | | up to Week 8 | | | | ID | Title | Description |
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| OG000 | Ruxolitinib 1.5% Cream BID | Participants applied ruxolitinib 1.5% cream twice daily (BID) to all areas identified for treatment at Baseline regardless of whether or not the lesion(s) improved for 8 weeks (Continuous Treatment Period). Participants who completed the Week 8 assessments with no safety concerns and with a percentage of body surface area (%BSA) affected by atopic dermatitis of no greater than 20% continued into the Long-term Safety (LTS) Period. During the 44 weeks of the LTS Period, the treatment regimen continued to be ruxolitinib 1.5% cream BID; however, participants only treated active atopic dermatitis lesions. |
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| Secondary | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing | Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Calcium, chloride, glucose, phosphate, potassium, sodium, and urea nitrogen were measured in millimoles per liter (mmol/L). | | Posted | | Count of Participants | | Participants | | up to Week 8 | | | | ID | Title | Description |
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| OG000 | Ruxolitinib 1.5% Cream BID | Participants applied ruxolitinib 1.5% cream twice daily (BID) to all areas identified for treatment at Baseline regardless of whether or not the lesion(s) improved for 8 weeks (Continuous Treatment Period). Participants who completed the Week 8 assessments with no safety concerns and with a percentage of body surface area (%BSA) affected by atopic dermatitis of no greater than 20% continued into the Long-term Safety (LTS) Period. During the 44 weeks of the LTS Period, the treatment regimen continued to be ruxolitinib 1.5% cream BID; however, participants only treated active atopic dermatitis lesions. |
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| Secondary | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Creatinine Clearance Value of Low, Normal, High, Low and High, and Missing | Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Creatinine clearance was measured in milliliters per minute per 1.73 square meters of body surface area (mL/min/1.73 m^2). | | Posted | | Count of Participants | | Participants | | up to Week 8 | | | | ID | Title | Description |
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| OG000 | Ruxolitinib 1.5% Cream BID | Participants applied ruxolitinib 1.5% cream twice daily (BID) to all areas identified for treatment at Baseline regardless of whether or not the lesion(s) improved for 8 weeks (Continuous Treatment Period). Participants who completed the Week 8 assessments with no safety concerns and with a percentage of body surface area (%BSA) affected by atopic dermatitis of no greater than 20% continued into the Long-term Safety (LTS) Period. During the 44 weeks of the LTS Period, the treatment regimen continued to be ruxolitinib 1.5% cream BID; however, participants only treated active atopic dermatitis lesions. |
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| Secondary | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing | Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. ALT, ALP, AST, CK, and LDH were measured in units per liter. | | Posted | | Count of Participants | | Participants | | from Week 9 up to Week 52 (44 weeks) | | | | ID | Title | Description |
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| OG000 | Ruxolitinib 1.5% Cream BID | Participants applied ruxolitinib 1.5% cream twice daily (BID) to all areas identified for treatment at Baseline regardless of whether or not the lesion(s) improved for 8 weeks (Continuous Treatment Period). Participants who completed the Week 8 assessments with no safety concerns and with a percentage of body surface area (%BSA) affected by atopic dermatitis of no greater than 20% continued into the Long-term Safety (LTS) Period. During the 44 weeks of the LTS Period, the treatment regimen continued to be ruxolitinib 1.5% cream BID; however, participants only treated active atopic dermatitis lesions. |
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| Secondary | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Albumin Value of Low, Normal, High, Low and High, and Missing | Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Albumin was measured in grams per liter. | | Posted | | Count of Participants | | Participants | | from Week 9 up to Week 52 (44 weeks) | | | | ID | Title | Description |
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| OG000 | Ruxolitinib 1.5% Cream BID | Participants applied ruxolitinib 1.5% cream twice daily (BID) to all areas identified for treatment at Baseline regardless of whether or not the lesion(s) improved for 8 weeks (Continuous Treatment Period). Participants who completed the Week 8 assessments with no safety concerns and with a percentage of body surface area (%BSA) affected by atopic dermatitis of no greater than 20% continued into the Long-term Safety (LTS) Period. During the 44 weeks of the LTS Period, the treatment regimen continued to be ruxolitinib 1.5% cream BID; however, participants only treated active atopic dermatitis lesions. |
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| Secondary | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Bilirubin, Creatinine, and Direct Bilirubin Value of Low, Normal, High, Low and High, and Missing | Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Bilirubin, creatinine, and direct bilirubin were measured in micromoles per liter (µmol/L). | | Posted | | Count of Participants | | Participants | | from Week 9 up to Week 52 (44 weeks) | | | | ID | Title | Description |
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| OG000 | Ruxolitinib 1.5% Cream BID | Participants applied ruxolitinib 1.5% cream twice daily (BID) to all areas identified for treatment at Baseline regardless of whether or not the lesion(s) improved for 8 weeks (Continuous Treatment Period). Participants who completed the Week 8 assessments with no safety concerns and with a percentage of body surface area (%BSA) affected by atopic dermatitis of no greater than 20% continued into the Long-term Safety (LTS) Period. During the 44 weeks of the LTS Period, the treatment regimen continued to be ruxolitinib 1.5% cream BID; however, participants only treated active atopic dermatitis lesions. |
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| Secondary | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing | Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Calcium, chloride, glucose, phosphate, potassium, sodium, and urea nitrogen were measured in millimoles per liter (mmol/L). | | Posted | | Count of Participants | | Participants | | from Week 9 up to Week 52 (44 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Ruxolitinib 1.5% Cream BID | Participants applied ruxolitinib 1.5% cream twice daily (BID) to all areas identified for treatment at Baseline regardless of whether or not the lesion(s) improved for 8 weeks (Continuous Treatment Period). Participants who completed the Week 8 assessments with no safety concerns and with a percentage of body surface area (%BSA) affected by atopic dermatitis of no greater than 20% continued into the Long-term Safety (LTS) Period. During the 44 weeks of the LTS Period, the treatment regimen continued to be ruxolitinib 1.5% cream BID; however, participants only treated active atopic dermatitis lesions. |
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| Secondary | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Creatinine Clearance Value of Low, Normal, High, Low and High, and Missing | Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Creatinine clearance was measured in milliliters per minute per 1.73 square meters of body surface area (mL/min/1.73 m^2). | | Posted | | Count of Participants | | Participants | | from Week 9 up to Week 52 (44 weeks) | | | | ID | Title | Description |
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| OG000 | Ruxolitinib 1.5% Cream BID | Participants applied ruxolitinib 1.5% cream twice daily (BID) to all areas identified for treatment at Baseline regardless of whether or not the lesion(s) improved for 8 weeks (Continuous Treatment Period). Participants who completed the Week 8 assessments with no safety concerns and with a percentage of body surface area (%BSA) affected by atopic dermatitis of no greater than 20% continued into the Long-term Safety (LTS) Period. During the 44 weeks of the LTS Period, the treatment regimen continued to be ruxolitinib 1.5% cream BID; however, participants only treated active atopic dermatitis lesions. |
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| Secondary | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 8, 44, and 52 | Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Full Analysis Set. Only participants with available data were analyzed. | Posted | | Mean | Standard Deviation | millimeters of mercury (mmHg) | | Baseline; Weeks 8, 44, and 52 | | | | ID | Title | Description |
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| OG000 | Ruxolitinib 1.5% Cream BID | Participants applied ruxolitinib 1.5% cream twice daily (BID) to all areas identified for treatment at Baseline regardless of whether or not the lesion(s) improved for 8 weeks (Continuous Treatment Period). Participants who completed the Week 8 assessments with no safety concerns and with a percentage of body surface area (%BSA) affected by atopic dermatitis of no greater than 20% continued into the Long-term Safety (LTS) Period. During the 44 weeks of the LTS Period, the treatment regimen continued to be ruxolitinib 1.5% cream BID; however, participants only treated active atopic dermatitis lesions. |
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| Secondary | Change From Baseline in Pulse at Weeks 8, 44, and 52 | Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Full Analysis Set. Only participants with available data were analyzed. | Posted | | Mean | Standard Deviation | beats per minute | | Baseline; Weeks 8, 44, and 52 | | | | ID | Title | Description |
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| OG000 | Ruxolitinib 1.5% Cream BID | Participants applied ruxolitinib 1.5% cream twice daily (BID) to all areas identified for treatment at Baseline regardless of whether or not the lesion(s) improved for 8 weeks (Continuous Treatment Period). Participants who completed the Week 8 assessments with no safety concerns and with a percentage of body surface area (%BSA) affected by atopic dermatitis of no greater than 20% continued into the Long-term Safety (LTS) Period. During the 44 weeks of the LTS Period, the treatment regimen continued to be ruxolitinib 1.5% cream BID; however, participants only treated active atopic dermatitis lesions. |
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| Secondary | Change From Baseline in Respiration Rate at Weeks 8, 44, and 52 | Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Full Analysis Set. Only participants with available data were analyzed. | Posted | | Mean | Standard Deviation | breaths per minute | | Baseline; Weeks 8, 44, and 52 | | | | ID | Title | Description |
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| OG000 | Ruxolitinib 1.5% Cream BID | Participants applied ruxolitinib 1.5% cream twice daily (BID) to all areas identified for treatment at Baseline regardless of whether or not the lesion(s) improved for 8 weeks (Continuous Treatment Period). Participants who completed the Week 8 assessments with no safety concerns and with a percentage of body surface area (%BSA) affected by atopic dermatitis of no greater than 20% continued into the Long-term Safety (LTS) Period. During the 44 weeks of the LTS Period, the treatment regimen continued to be ruxolitinib 1.5% cream BID; however, participants only treated active atopic dermatitis lesions. |
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| Secondary | Change From Baseline in Body Temperature at Weeks 8, 44, and 52 | Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Full Analysis Set. Only participants with available data were analyzed. | Posted | | Mean | Standard Deviation | degrees Celsius | | Baseline; Weeks 8, 44, and 52 | | | | ID | Title | Description |
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| OG000 | Ruxolitinib 1.5% Cream BID | Participants applied ruxolitinib 1.5% cream twice daily (BID) to all areas identified for treatment at Baseline regardless of whether or not the lesion(s) improved for 8 weeks (Continuous Treatment Period). Participants who completed the Week 8 assessments with no safety concerns and with a percentage of body surface area (%BSA) affected by atopic dermatitis of no greater than 20% continued into the Long-term Safety (LTS) Period. During the 44 weeks of the LTS Period, the treatment regimen continued to be ruxolitinib 1.5% cream BID; however, participants only treated active atopic dermatitis lesions. |
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| Secondary | Change From Baseline in Height at Weeks 8 and 52 | Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Full Analysis Set. Only participants with available data were analyzed. | Posted | | Mean | Standard Deviation | centimeters | | Baseline; Weeks 8 and 52 | | | | ID | Title | Description |
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| OG000 | Ruxolitinib 1.5% Cream BID | Participants applied ruxolitinib 1.5% cream twice daily (BID) to all areas identified for treatment at Baseline regardless of whether or not the lesion(s) improved for 8 weeks (Continuous Treatment Period). Participants who completed the Week 8 assessments with no safety concerns and with a percentage of body surface area (%BSA) affected by atopic dermatitis of no greater than 20% continued into the Long-term Safety (LTS) Period. During the 44 weeks of the LTS Period, the treatment regimen continued to be ruxolitinib 1.5% cream BID; however, participants only treated active atopic dermatitis lesions. |
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| Secondary | Change From Baseline in Weight at Weeks 8 and 52 | Change from Baseline was calculated as the post-Baseline value minus the Baseline value. | Full Analysis Set. Only participants with available data were analyzed. | Posted | | Mean | Standard Deviation | kilograms | | Baseline; Weeks 8 and 52 | | | | ID | Title | Description |
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| OG000 | Ruxolitinib 1.5% Cream BID | Participants applied ruxolitinib 1.5% cream twice daily (BID) to all areas identified for treatment at Baseline regardless of whether or not the lesion(s) improved for 8 weeks (Continuous Treatment Period). Participants who completed the Week 8 assessments with no safety concerns and with a percentage of body surface area (%BSA) affected by atopic dermatitis of no greater than 20% continued into the Long-term Safety (LTS) Period. During the 44 weeks of the LTS Period, the treatment regimen continued to be ruxolitinib 1.5% cream BID; however, participants only treated active atopic dermatitis lesions. |
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| Secondary | Plasma Concentration of Ruxolitinib | Blood samples were drawn to assess plasma concentration. | Pharmacokinetic (PK) Population: all participants who applied ruxolitinib cream at least once and provided at least 1 postbaseline PK sample (1 PK measurement). Only participants with available data were analyzed. | Posted | | Mean | Standard Deviation | nanomoles per liter (nM) | | prior to study cream application at Weeks 2 and 4 | | | | ID | Title | Description |
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| OG000 | Ruxolitinib 1.5% Cream BID | Participants applied ruxolitinib 1.5% cream twice daily (BID) to all areas identified for treatment at Baseline regardless of whether or not the lesion(s) improved for 8 weeks (Continuous Treatment Period). Participants who completed the Week 8 assessments with no safety concerns and with a percentage of body surface area (%BSA) affected by atopic dermatitis of no greater than 20% continued into the Long-term Safety (LTS) Period. During the 44 weeks of the LTS Period, the treatment regimen continued to be ruxolitinib 1.5% cream BID; however, participants only treated active atopic dermatitis lesions. |
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