Please select the outcome measures that correspond to the clinical trial below.
Title: A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, VEHICLE-CONTROLLED STUDY, TO CHARACTERIZE THE MECHANISM OF ACTION OF CRISABOROLE OINTMENT 2%, BY EVALUATION OF EFFICACY AND CHANGES IN SKIN BIOMARKERS, IN ADULT SUBJECTS WITH MILD TO MODERATE ATOPIC DERMATITIS, WITH A 4 WEEK OPEN-LABEL EXTENSION
Brief Summary: This study is being conducted to characterize the mechanism of action of crisaborole ointment 2%, by evaluation of efficacy and changes in key skin biomarkers in atopic dermatitis (AD) lesions treated with crisaborole ointment 2% over vehicle, in subjects with mild to moderate AD. Two identified AD skin lesions for each subject will be treated for the first 15 days, one with crisaborole ointment 2% and one with vehicle, in a blinded manner, and biopsies for biomarker analysis will be performed on the lesions. Following completion of the blinded treatment period, subjects will start the 28 day open label period during which all AD affected skin lesions will be treated with crisaborole ointment 2% twice daily.


Options:
A: Adherence to topical Therapy (12 months)
B: Change From Baseline in Lesion Total Sign Score (TSS) for Target Lesions Treated With Crisaborole Ointment 2% or Vehicle at Day 15 (Baseline (Day 1), Day 15); Change From Baseline in Key Skin Biomarker Chemokine Ligand (CCL)17 Expression in Target Lesions Treated With Crisaborole Ointment 2% or Vehicle at Day 15 (Baseline (Day 1), Day 15); Change From Baseline in Key Skin Biomarker CCL18 Expression in Target Lesions Treated With Crisaborole Ointment 2% or Vehicle at Day 15 (Baseline (Day 1), Day 15); Change From Baseline in Key Skin Biomarker CCL22 Expression in Target Lesions Treated With Crisaborole Ointment 2% or Vehicle at Day 15 (Baseline (Day 1), Day 15); Change From Baseline in Key Skin Biomarker Interleukin (IL)-13 Expression in Target Lesions Treated With Crisaborole Ointment 2% or Vehicle at Day 15 (Baseline (Day 1), Day 15); Change From Baseline in Key Skin Biomarker Keratin 16 (KRT16) Expression in Target Lesions Treated With Crisaborole Ointment 2% or Vehicle at Day 15 (Baseline (Day 1), Day 15); Change From Baseline in Key Skin Biomarker Elafin/Peptidase Inhibitor 3 (PI3) Expression in Target Lesions Treated With Crisaborole Ointment 2% or Vehicle at Day 15 (Baseline (Day 1), Day 15); Change From Baseline in Key Skin Biomarker S100 Calcium Binding Protein A12 (S100A12) Expression in Target Lesions Treated With Crisaborole Ointment 2% or Vehicle at Day 15 (Baseline (Day 1), Day 15)
C: Mean Percentage Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 4 in Participants Treated With Ruxolitinib 1.5% Cream Twice a Day (BID) Compared With Participants Treated With Vehicle Cream BID (Baseline and Week 4)
D: Percentage of Participants Who Achieved Success in Investigator's Static Global Assessment (ISGA) Score at Day 29 (Day 29); Number of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs) (AEs: Baseline (Day 1) up to Day 29, SAEs: Baseline (Day 1) up to Day 36); Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings at Day 8 (Baseline, Day 8); Number of Participants With Clinically Significant Change From Baseline in Vital Signs at Day 36 (Baseline (Day 1), Day 36); Number of Participants With Clinically Significant Laboratory Values (Baseline up to Day 36); Percentage of Participants With Local Tolerability Symptoms at Baseline (Baseline (Day 1)); Percentage of Participants With Local Tolerability Symptoms at Day 8 (Day 8); Percentage of Participants With Local Tolerability Symptoms at Day 15 (Day 15); Percentage of Participants With Local Tolerability Symptoms at Day 22 (Day 22); Percentage of Participants With Local Tolerability Symptoms at Day 29 (Day 29); Percentage of Participants With Local Tolerability Symptoms at Day 36 (Day 36)

Answer: B