Journal of Clinical and Aesthetic Dermatology

MAY 2018

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

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31 JCAD JOURNAL OF CLINICAL AND AESTHETIC DERMATOLOGY May 2018 • Volume 11 • Number 5 O R I G I N A L R E S E A R C H Park, New Jersey, USA) to apply three times daily to the affected areas. In addition, a target site representing an area of sensitive skin was selected for evaluation of improvement characteristics in comparison with baseline. The target site was photographed at each visit by the investigator. Subjects completed a diary and made an entry for each product application, including comments, if necessary, to ensure adherence. In addition, subjects were given an application map, noting the target area on the arms or legs, to ensure that applications were made to the proper evaluation areas. Subjects underwent evaluation and photography at baseline, Week 2, and Week 4, with the examinations performed at least eight hours following the last application of the study cream. Evaluations consisted of an Investigator Global Assessment (IGA) scale score and subject self-assessment (SA), both with the scale of 0=none, 1=minimal, 2=mild, 3=moderate, and 4=severe for each skin parameter. IGA skin parameters included irritation, erythema, desquamation, roughness, dryness, and overall appearance, and the SA parameters included irritation, redness, peeling, roughness, and overall appearance. Target area noninvasive assessments were also made for transepidermal water loss (TEWL; Evaporimeter; Cortex Technologies, Hadsund, Denmark), corneometry (Pin Probe; Cortex Technologies, Hadsund, Denmark), and colorimetry (L*a*b scale; Minolta, Osaka, Japan) to ensure consistency in the evaluation site. Since the data were either not normally distributed by the Shapiro–Wilk test or were not continuous, significant differences from baseline were evaluated by the nonparametric paired Wilcoxon signed-rank test. Since multiple nonindependent comparisons were made with baseline, Bonferroni correction was applied to the customary significance level of p=0.05. In this case, two comparisons (at 2 weeks and 4 weeks) were made with baseline, so the cutoff level was adjusted by dividing 0.05 by two to arrive at p=0.025. The safety population included all subjects exposed to the study product who provided any post-treatment safety information. RESULTS All subjects completed the research project and adhered with the treatment protocol. No investigator- or subject-reported safety or lack of tolerance issues arose during the study. IGA data (Table 1) for the study cream revealed a 100-percent difference from baseline with respect to irritation, erythema, desquamation, roughness, and overall appearance after both two weeks and four weeks of application. The IGA score was based on an overall evaluation of all affected body areas. All differences were statistically significant compared to baseline (p<0.0001). IGA data for the target site were composed of the median score of all five parameters at baseline, two weeks, and four weeks. Subjects entered the study with a median score of 2.0, which decreased to 0.5 at two weeks (75% decrease) and 0.0 at four weeks (100% decrease). Both changes were statistically significant (p<0.0001). Subject target area assessments (Table 1) also indicated a statistically significant decrease in irritation, redness, peeling, roughness, and overall assessment (p<0.0001) at both Week 2 and Week 4. Median scores at Week 2 ranged from 0 to 50 percent compared to baseline, and continued to decrease to 50 to 100 percent at Week 4. The reductions were all statistically significant (p<0.001) at Week 2 and Week 4. Three noninvasive assessments were also conducted to provide more objective data. A colorimeter was used to evaluate the color of the skin pre- and post-application of the ceramide cream. The L scale was used to assess light reflection from the skin surface, which is directly related to skin smoothness. 5 The L scale reading decreased compared to baseline at four weeks and achieved significance (p<0.0001). The amounts of water in the skin and water leaving the skin were also evaluated. Corneometry was used to assess the water in the skin. Over the four TABLE 1. Investigator target score and subject assessments of ceramide-based cream ASSESSMENT MEDIAN (IQR) DIFFERENCE (%) P VALUE BASELINE 2 WEEKS 4 WEEKS 2 WEEKS 4 WEEKS 2 WEEKS 4 WEEKS INGESTIGATOR GLOBAL Irritation 2.0 (1.0) 0.0 (1.0) 0.0 (0.0) -100 -100 <0.0001 (s) <0.0001 (s) Erythema 2.0 (1.0) 0.0 (1.0) 0.0 (0.0) -100 -100 <0.0001 (s) <0.0001 (s) Desquamation 2.0 (1.0) 0.0 (1.0) 0.0 (0.0) -100 -100 <0.0001 (s) <0.0001 (s) Roughness 2.0 (1.0) 0.0 (1.0) 0.0 (0.0) -100 -100 <0.0001 (s) <0.0001 (s) Overall 2.0 (1.0) 0.0 (1.0) 0.0 (0.0) -100 -100 <0.0001 (s) <0.0001 (s) INVESTIGATOR TARGET* 2.0 (1.0) 0.5 (1.0) 0.0 (0.0) -75 -100 <0.0001 (S) <0.0001 (S) SUBJECT TARGET Irritation 3.0 (0.0) 2.0 (0.2) 1.0 (2.0) -33 -67 <0.0001 (s) <0.0001 (s) Redness 2.0 (1.0) 2.0 (1.0) 0.0 (2.0) 0 -50 <0.0001 (s) <0.0001 (s) Peeling 2.0 (1.0) 1.0 (1.0) 0.0 (2.0) -50 -100 <0.0001 (s) <0.0001 (s) Roughness 3.0 (1.0) 2.0 (1.1) 1.0 (2.0) -33 -67 <0.0001 (s) <0.0001 (s) Overall 3.0 (1.0) 2.0 (1.1) 1.0 (1.0) -33 -67 <0.0001 (s) <0.0001 (s) IQR; interquartile range (the difference between the 75th and 25th percentile values); s: significant Assessment scale: 0=none, 1=minimal, 2=mild, 3=moderate, and 4=severe. The investigator target score is the median of irritation, erythema, descquamatin, roughness, and overall scores

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