Journal of Clinical and Aesthetic Dermatology

Skinfix 2018

An evidence-based, peer-reviewed journal for practicing clinicians in the field of dermatology

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S5 JCAD JOURNAL OF CLINICAL AND AESTHETIC DERMATOLOGY January 2018 • Volume 11 • Number 1 • Supplement T H E I M P O R TA N C E O F S K I N B A R R I E R M A I N T E N A N C E A N D R E PA I R one active AD/ED lesion; and SCORing Atopic Dermatitis (SCORAD) value less than 50. Thirty- eight subjects were enrolled; 37 completed the study (1 EB subject chose to withdraw). Seventeen subjects used EB and 20 used HC 1%. Assessments. Efficacy assessments at each study time point were SCORAD and Investigator Global Improvement Assessment (IGIA ranked 1 [worse] to 5 [markedly improved]). The following were also assessed and tabulated independently with changes evaluated as compared to baseline at each study visit: A=Area Scores (BSA affected); B=Intensity Scores (erythema, swelling, oozing/crusting, excoriations, lichenification, dryness); and C=Subjective Symptom Scores (pruritus, sleeplessness). Quality-of-life (QoL) was evaluated using Dermatology Life Quality Index (DLQI). TEWL was assessed using a target lesion selected by a board- certified dermatologist investigator. TEWL measurements were completed under standardized conditions of acclimation and controlled temperature/humidity using triplicate Tewameter measurements. Safety evaluations included capturing of cutaneous tolerability parameters of erythema, dryness/ scaling, peeling, edema, burning, stinging, tightness, and tingling using a 5-point scoring scale (0=none, 1=mild, 2=moderate, 3=severe). Efficacy outcomes. Overall, no significant differences were noted between both study groups in efficacy. Based on IGIA (Figure 1) and assessments of Area Affected (A), Intensity (B), Subjective Symptoms (C), and overall SCORAD results (Table 2), EB resulted in marked decreases from baseline in the signs and symptoms of AD/ED, with nearly all changes in clinical features achieving statistical significance within two weeks and sustained throughout Week 4. There were no significant differences versus HC 1% for nearly all measures. HC 1% did produce significantly greater reductions in exudation and excoriation versus EB at Week 2 and in sleeplessness at Weeks 2 and 4. EB significantly decreased TEWL at Week 2 and Week 4 while HC 1% produced a significant reduction only at Week 2. This latter finding might be explained by EB more directly improving SC barrier function with resultant reduction in FIGURE 1: Investigator Global Improvement Assessment (IGIA): Changes in rating at Week 2 and Week 4 between eczema balm-treated group and hydrocortisone-treated group TABLE 2: SCORing Atopic Dermatitis (SCORAD) evaluations: Mean percent change from baseline at Week 2 and Week 4; Eczema Balm (EB) vs. hydrocortisone 1% cream (HC) SCORE MEAN PERCENT CHANGE FROM BASELINE AT WEEK 2 P-VALUE MEAN PERCENT CHANGE FROM BASELINE AT WEEK 4 P-VALUE Area Score "A" (%) EB -37.2 0.031 -53.8 0.004 HC -34 0.004 -56.5 <0.001 Intensity Score "B" EB -54.2 <0.001 -69.6 <0.001 HC -52.3 <0.001 -75.2 <0.001 Subjective Symptoms Score "C" EB -64.9 <0.001 -81.3 <0.001 HC -70.6 <0.001 -84.6 <0.001 Overall SCORAD Score EB -56.5 <0.001 -72.2 <0.001 HC -56.9 <0.001 -77.5 <0.001 No statistically significant differences noted in area affected (A), intensity score (B), subjective symptoms score (C), and overall SCORAD score results between study groups at Week 2 and Week 4

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