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    HP:0000964: Eczema

    Developed by Shray Alag, The Harker School
    Sections: Correlations, Clinical Trials, and HPO

    Correlations computed by analyzing all clinical trials.

    Navigate: Clinical Trials and HPO


    Correlated Drug Terms (5)


    Name (Synonyms) Correlation
    drug1692 Hand sanitizer and hand washing Wiki 0.58
    drug817 CYP 450 Substrates Wiki 0.58
    drug146 ATI-1777 Wiki 0.58
    Name (Synonyms) Correlation
    drug2526 Nemolizumab Wiki 0.58
    drug4202 Vehicle Wiki 0.58

    Correlated MeSH Terms (4)


    Name (Synonyms) Correlation
    D003876 Dermatitis, Atopic NIH 1.00
    D004485 Eczema NIH 1.00
    D003872 Dermatitis NIH 0.87
    Name (Synonyms) Correlation
    D012868 Skin Abnormalities NIH 0.58

    Correlated HPO Terms (3)


    Name (Synonyms) Correlation
    HP:0001047 Atopic dermatitis HPO 1.00
    HP:0011123 Inflammatory abnormality of the skin HPO 0.87
    HP:0000951 Abnormality of the skin HPO 0.41

    Clinical Trials

    Navigate: Correlations   HPO

    There are 3 clinical trials


    1 Hand Sanitizer Effects on the Skin Barrier

    Hand washing and the use of hand sanitizers are important interventions in disease prevention. Engaging in frequent hand washing is especially effective in preventing the spread of viruses, as this removes microbes and prevents the spread to others. Hand dermatitis, however, is a common occurrence in certain occupations, such as healthcare workers. With the onset of the SARS-CoV2 (COVID-19) pandemic, hand hygiene measures are further enforced as there is no cure or vaccine for this virus. In the study, the effects of hand washing and the use of hand sanitizer on skin proteins and lipids will be assessed.

    NCT04525521
    Conditions
    1. Dermatitis Hand
    2. Skin Abnormalities
    3. Atopic Dermatitis
    4. Atopic Dermatitis Eczema
    Interventions
    1. Other: Hand sanitizer and hand washing
    MeSH:Dermatitis, Atopic Skin Abnormalities Dermatitis Eczema
    HPO:Abnormality of the skin Atopic dermatitis Eczema Eczematoid dermatitis Inflammatory abnormality of the skin

    Primary Outcomes

    Description: Skin barrier assessments at baseline, then after hand sanitizer use will be performed. Analysis of skin filaggrin breakdown products, lipid profiles, and transepidermal water loss will be compared.

    Measure: Measure the change in transepidermal water loss and skin components after using hand sanitizer.

    Time: Through study completion, up to 1 year

    Description: Skin barrier assessments after hand washing with soap and water will be performed. Analysis of skin filaggrin breakdown products, lipid profiles, and transepidermal water loss will be compared.

    Measure: Measure the change in transepidermal water loss and skin components after hand washing with soap and water.

    Time: Through study completion, up to 1 year

    Secondary Outcomes

    Description: Questionnaires will capture symptoms of hand dryness, frequency of hand washing, and other environmental exposures. This data will be compared to the degree of transepidermal water loss and skin barrier findings.

    Measure: Individual reporting of hand dryness and environmental exposures

    Time: Through study completion, up to 1 year
    2 An Open-label Drug-Drug Interaction Study to Assess the Effects of Nemolizumab on Cytochrome P450 Substrates in Subjects With Moderate-to-Severe Atopic Dermatitis

    The purpose of this study is to evaluate the effect of nemolizumab (CD14152) on the pharmacokinetics (PK) of a drug "cocktail" representative of CYP450 (CYP1A2, CYP2C9, CYP2C19, CYP2D6 and CYP3A4/5 sensitive index substrates) in adult participants with moderateto- severe atopic dermatitis (AD).

    NCT04562116
    Conditions
    1. Atopic Dermatitis
    Interventions
    1. Drug: Nemolizumab
    2. Drug: CYP 450 Substrates
    MeSH:Dermatitis, Atopic Dermatitis Eczema
    HPO:Atopic dermatitis Eczema Eczematoid dermatitis Inflammatory abnormality of the skin

    Primary Outcomes

    Description: Change of AUC (0-infinity) of each of the 5 probe drugs before and after 9-week nemolizumab treatment will be assessed. AUC (0-infinity) is defined as AUC from time 0 to infinity, calculated as the sum of AUC (0-last) and C(last)/lambda(z); where C(last) is the last observed measurable (non-BQL) concentration; and lambda(z) is apparent terminal elimination rate constant.

    Measure: Change of Area Under the Concentration-time Curve from Time Zero to Infinity (AUC[0-infinity]) of Each of the 5 Probe Drugs Before and After 9-week Nemolizumab Treatment

    Time: Baseline (Week 0) and Week 10: Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 72 and 120 hours post-dose'

    Description: Change of AUC (0-last) of each of the 5 probe drugs before and after 9-week nemolizumab treatment will be assessed. AUC (0-last) is defined as AUC from time 0 to the time of the last measurable (non-below quantification limit [non-BQL]) concentration, calculated by linear-linear trapezoidal summation.

    Measure: Change of Area Under the Concentration-time Curve from Time Zero to the Time of the Last Measurable Concentration (AUC [0-last]) of Each of the 5 Probe Drugs Before and After 9-week Nemolizumab Treatment

    Time: Baseline (Week 0) and Week 10: Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 72 and 120 hours post-dose'

    Description: Change of Cmax of each of the 5 probe drugs before and after 9-week nemolizumab treatment will be assessed. Cmax is defined as the maximum observed plasma concentration.

    Measure: Maximum Observed Plasma Concentration (Cmax) of Each of the 5 Probe Drugs Before and After 9-week Nemolizumab Treatment

    Time: Baseline (Week 0) and Week 10: Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 72 and 120 hours post-dose'

    Secondary Outcomes

    Description: Incidence of AEs including treatment emergent AEs (TEAEs), AEs of special interest (AESIs), and serious AEs (SAEs) will be reported. An AE is defined as any untoward medical occurrence in a study participant administered a medicinal product which does not necessarily have a causal relationship with this treatment. SAE is any untoward medical occurrence that at any dose may results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product. A TEAE is defined as an AE that occurs on or after the first date of study drug(s) administration until the date of last study visit. An AESI is a noteworthy treatment-emergent event for the study drug that should be monitored closely and reported promptly.

    Measure: Incidence of Adverse Events (AEs)

    Time: Up to 24 weeks

    Description: The severity of AEs including TEAEs, AESIs, and SAEs will be assessed as mild, moderate or severe.

    Measure: Severity of Adverse Events (AEs)

    Time: Up to 24 weeks
    3 A Phase 2a, Multicenter, Randomized, Double-blind, Vehicle-controlled, Parallel-group Study to Determine the Safety, Tolerability, Pharmacokinetics and Efficacy of ATI-1777 in Adult Patients With Moderate or Severe Atopic Dermatitis

    This is a first-in-human, randomized, double-blind, parallel-group, vehicle-controlled study to evaluate the efficacy, safety, tolerability, and PK of ATI-1777 solution following twice-daily applications to target areas of patients with moderate or severe atopic dermatitis.

    NCT04598269
    Conditions
    1. Atopic Dermatitis
    Interventions
    1. Drug: ATI-1777
    2. Drug: Vehicle
    MeSH:Dermatitis, Atopic Dermatitis Eczema
    HPO:Atopic dermatitis Eczema Eczematoid dermatitis Inflammatory abnormality of the skin

    Primary Outcomes

    Description: EASI = Eczema Area and Severity Index. The EASI evaluation is performed by the Principal Investigator and will evaluate Atopic Dermatitis in each of 3 body regions (trunk [excluding groin and genitalia], upper extremities [excluding palms of hands], and lower extremities [excluding soles of feet]). The EASI scoring system uses a defined process to grade the severity of the signs of AD and the extent affected. EASI Scores range from 0-72, with higher score indicative of more severe disease.

    Measure: Percent change from baseline in EASI score at Day 28

    Time: Baseline to Day 28

    Secondary Outcomes

    Description: EASI = Eczema Area and Severity Index. The EASI evaluation is performed by the Principal Investigator and will evaluate Atopic Dermatitis in each of 3 body regions (trunk [excluding groin and genitalia], upper extremities [excluding palms of hands], and lower extremities [excluding soles of feet]). The EASI scoring system uses a defined process to grade the severity of the signs of AD and the extent affected. EASI Scores range from 0-72, with higher score indicative of more severe disease.

    Measure: Percent change from baseline in EASI score at Day 8

    Time: Baseline to Day 8

    Description: EASI = Eczema Area and Severity Index. The EASI evaluation is performed by the Principal Investigator and will evaluate Atopic Dermatitis in each of 3 body regions (trunk [excluding groin and genitalia], upper extremities [excluding palms of hands], and lower extremities [excluding soles of feet]). The EASI scoring system uses a defined process to grade the severity of the signs of AD and the extent affected. EASI Scores range from 0-72, with higher score indicative of more severe disease.

    Measure: Percent change from baseline in EASI score at Day 15

    Time: Baseline to Day 15

    Description: EASI = Eczema Area and Severity Index. The EASI evaluation is performed by the Principal Investigator and will evaluate Atopic Dermatitis in each of 3 body regions (trunk [excluding groin and genitalia], upper extremities [excluding palms of hands], and lower extremities [excluding soles of feet]). The EASI scoring system uses a defined process to grade the severity of the signs of AD and the extent affected. EASI Scores range from 0-72, with higher score indicative of more severe disease.

    Measure: Proportion of patients who achieve 50% improvement in EASI score (EASI 50) within 28 days of the start of treatment

    Time: Day 28

    Description: EASI = Eczema Area and Severity Index. The EASI evaluation is performed by the Principal Investigator and will evaluate Atopic Dermatitis in each of 3 body regions (trunk [excluding groin and genitalia], upper extremities [excluding palms of hands], and lower extremities [excluding soles of feet]). The EASI scoring system uses a defined process to grade the severity of the signs of AD and the extent affected. EASI Scores range from 0-72, with higher score indicative of more severe disease.

    Measure: Proportion of patients who achieve 75% improvement in EASI score (EASI-75) within 4 weeks of the start of treatment

    Time: Baseline to Day 28

    Description: EASI = Eczema Area and Severity Index. The EASI evaluation is performed by the Principal Investigator and will evaluate Atopic Dermatitis in each of 3 body regions (trunk [excluding groin and genitalia], upper extremities [excluding palms of hands], and lower extremities [excluding soles of feet]). The EASI scoring system uses a defined process to grade the severity of the signs of AD and the extent affected. EASI Scores range from 0-72, with higher score indicative of more severe disease.

    Measure: Proportions of patients who achieve 90% improvement in EASI score (EASI-90) within 4 weeks of the start of treatment

    Time: Baseline to Day 28

    Description: IGA = Validated Investigator Global Assessment scale for Atopic Dermatitis. The IGA is the investigator's assessment of the average overall severity of patient's AD at a particular point in time. Scores range from 0-4, with higher scores indicative of more severe disease.

    Measure: Change from baseline in IGA score at Day 8

    Time: Baseline to Day 8

    Description: IGA = Validated Investigator Global Assessment scale for Atopic Dermatitis. The IGA is the investigator's assessment of the average overall severity of patient's AD at a particular point in time. Scores range from 0-4, with higher scores indicative of more severe disease.

    Measure: Change from baseline in IGA score at Day 15

    Time: Baseline to Day 15

    Description: IGA = Validated Investigator Global Assessment scale for Atopic Dermatitis. The IGA is the investigator's assessment of the average overall severity of patient's AD at a particular point in time. Scores range from 0-4, with higher score indicative of more severe disease. 0-100%, with higher score indicative of increased percentage of atopic dermatitis on the skin.

    Measure: Change from baseline in IGA score at Day 28

    Time: Baseline to Day 28

    Description: BSA = Percent of Body Surface Area of Atopic Dermatitis. The total percentage of the patient's BSA affected by AD will be estimated by the investigator or designee using the handprint method, which estimates that the area of a patient's full handprint (fingers and thumbs together) constitutes 1% of their total BSA. Scores range from 0-100%, with higher score indicative of increased percentage of atopic dermatitis on the skin.

    Measure: Change from baseline in BSA at Day 8

    Time: Baseline to Day 8

    Description: BSA = Percent of Body Surface Area of Atopic Dermatitis. The total percentage of the patient's BSA affected by AD will be estimated by the investigator or designee using the handprint method, which estimates that the area of a patient's full handprint (fingers and thumbs together) constitutes 1% of their total BSA. Scores range from 0-100%, with higher score indicative of increased percentage of atopic dermatitis on the skin.

    Measure: Change from baseline in BSA at Day 15

    Time: Baseline to Day 15

    Description: BSA = Percent of Body Surface Area of Atopic Dermatitis. The total percentage of the patient's BSA affected by AD will be estimated by the investigator or designee using the handprint method, which estimates that the area of a patient's full handprint (fingers and thumbs together) constitutes 1% of their total BSA. Scores range from 0-100%, with higher score indicative of increased percentage of atopic dermatitis on the skin.

    Measure: Change from baseline in BSA at Day 28

    Time: Baseline to Day 28

    Description: PP-NRS = Peak Pruritus Numerical Rating Scale. The PP-NRS is a single patient-reported item designed to measure peak pruritus, or 'worst' itch, over the previous 24 hours. Scores range from 0-10, with higher scores indicative of more severe itching.

    Measure: Change from baseline in PP-NRS score at Day 8

    Time: Baseline to Day 8

    Description: PP-NRS = Peak Pruritus Numerical Rating Scale. The PP-NRS is a single patient-reported item designed to measure peak pruritus, or 'worst' itch, over the previous 24 hours. Scores range from 0-10, with higher scores indicative of more severe itching.

    Measure: Change from baseline in PP-NRS at Day 15

    Time: Baseline to Day 15

    Description: PP-NRS = Peak Pruritus Numerical Rating Scale. The PP-NRS is a single patient-reported item designed to measure peak pruritus, or 'worst' itch, over the previous 24 hours. Scores range from 0-10, with higher scores indicative of more severe itching.

    Measure: Change from baseline in PP-NRS score at Day 28

    Time: Baseline to Day 28

    Other Outcomes

    Description: Laboratory measure will be categorized as normal, high, or low. Normal laboratory values represent better outcomes. Laboratory measures include White Blood Cell (WBC) Count, Absolute Neutrophil Count (ANC), Aspartate Aminotransferase, Lymphocyte count, Platelet count, Hemoglobin, and Serum creatinine. The status at the final value at the end of the treatment period will be compared with that at the study baseline and the "shifts" from study baseline will be summarized using the number and percentage of patients in each shift category by treatment group.

    Measure: Proportion of Subjects Experiencing a Shift from Baseline Laboratory Values

    Time: Baseline to Day 28

    Description: Laboratory measure will be summarized using descriptive statistics for numeric variables and numbers and percentages for categorical variables at each scheduled assessment. Numeric hematology, chemistry, and urinalysis results will be summarized using change from baseline as well.

    Measure: Summary of Hematology at Day 28

    Time: Baseline to Day 28

    Description: Laboratory measure will be summarized using descriptive statistics for numeric variables and numbers and percentages for categorical variables at each scheduled assessment. Numeric hematology, chemistry, and urinalysis results will be summarized using change from baseline as well.

    Measure: Summary of Serum Chemistry at Day 28

    Time: Baseline to Day 28

    Description: Laboratory measure will be summarized using descriptive statistics for numeric variables and numbers and percentages for categorical variables at each scheduled assessment. Numeric hematology, chemistry, and urinalysis results will be summarized using change from baseline as well.

    Measure: Summary of Urinalysis at Day 28

    Time: Baseline to Day 28

    Description: Vital signs will be presented descriptively. Vital signs will be measured in a semi-supine position after 5 minutes of rest and will include temperature, systolic and diastolic blood pressure, pulse, and respiratory rate.

    Measure: Summary of Abnormal Vital Signs at Day 8

    Time: Baseline to Day 8

    Description: Vital signs will be presented descriptively. Vital signs will be measured in a semi-supine position after 5 minutes of rest and will include temperature, systolic and diastolic blood pressure, pulse, and respiratory rate.

    Measure: Summary of Abnormal Vital Signs at Day 15

    Time: Baseline to Day 15

    Description: Vital signs will be presented descriptively. Vital signs will be measured in a semi-supine position after 5 minutes of rest and will include temperature, systolic and diastolic blood pressure, pulse, and respiratory rate.

    Measure: Summary of Abnormal Vital Signs at Day 28

    Time: Baseline to Day 28

    Description: ECG = Electrocardiogram. Clinically significant ECG findings include, but not limited to, ectopic atrial rhythm, clinically significant conduction disturbance including PR >240 msec, pre-excitation (delta wave and PR < 120 msec), second degree or higher atrioventricular block, new finding of QRS > 120 ms, evidence of of QT-interval prolongation, and acute signs of ischemia or infarction.

    Measure: Summary of Abnormal Physical 12-lead ECG reading at Day 28

    Time: Baseline to Day 28

    HPO Nodes


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