Integrated Scoring Scale for Visual Evaluation of Heel Skin Condition 12. September 2018 Integrated Scoring Scale for Visual Evaluation of Heel Skin Condition EA Moyer, PSM, CCRC and LK Lockhart, PhD, Henkel Consumer Goods Inc., Scottsdale AZ Background Descriptive scoring scales are often preferable to global scales to promote consistency between evaluators and are often required by regulatory agencies. Visual descriptors of xerosis are usually described in terms of the degree of defect in corneocyte sloughing around the dermatoglyphic triangles. Dry skin traditionally presents with flaking and peeling. Heel Dryness and Fissuring The skin on the heel is unique in that the stratum corneum is considerably thicker than any other body area and the heels are subject to considerable mechanical stress. Skin on the heel also experiences fissuring (cracking) but increased dryness does not necessarily correlate with increased fissuring. As a result, traditional approaches to evaluating skin dryness do not correlate well when applied skin on the heels. Severity as a Function of Dryness and Fissuring Application of Scoring Scale Subjects were evaluated at baseline, 1 week, and 2 weeks following use of a moisturizer. Each heel was evaluated using the individual dryness and fissuring scoring scales. The New Qualified Global Score is the best score as it takes into account both dryness and fissuring weighted appropriately. Plot of Dryness vs. Fissuring verified that there is not a good direct correlation between the two variables. Heels were then assigned a overall severity rating on a global 9-point scale ranging from none, mild, moderate, severe, and extreme. Unqualified Global Score Fissuring Dryness Qualified Global Score 3.50 3.75 3.25 3.52 2.50 3.00 2.75 2.89 2.65 Baseline Figure 1. Degrees of skin condition on the heels 1week No Dryness No Fissuring Fissuring Slight Dryness Dryness Severity scale shows relative correlation between dryness and fissuring and total score. 2 weeks A regression analysis was run to better understand how dryness and fissuring are weighted when ranked by a global severity scale scores. Dryness and fissuring both play a significant role in the overall score. Dryness accounts for 66% of the score while fissuring accounts for 34% of the overall score. Global Score = 0.128 +0.633*dryness + 0.313*fissuring † R2=0.87 †Patent Pending Independent Scales Developed Heels of employees were first evaluated to understand the varying degrees of damage present and to develop dryness descriptors unique to the heel. Heels were initially evaluated according to the traditional dryness scoring scale. Further evaluation of the traditional scoring scale determined cracking and fissuring did not always follow a logical progression as first hypothesized. Separate scoring scales were developed to rate dryness and fissuring independently. Expert Evaluations vs. Subjective In addition to expert evaluations of dryness and fissuring, subjects who participated in the study were also asked to evaluate their heel condition. The subjective evaluations did not correlate well with the expert evaluations. Those with relatively “good” heels often viewed their condition as worse than the expert. Subject evaluations did not realize improvement, differed more from the expert as the study continued. Grade Dryness None 0.5 Perceptible dryness 1.0 Mild (uniform powdery white) 2.0 Moderate (uniform, marked flaking covering more than 50% of the test site) 3.0 Severe (Moderate to severe scaling with uplifting scales) 4.0 Extreme (dryness with areas of loose skin or epidermis absent) Cosmetic vs. Dermatologist View A Dermatologist, Dr. Zoe Diana Draelos evaluated photos taken of damaged heels. Of the 131 heels evaluated, 87% of the scores were within 0.5 points and the correlation coefficient between the two data sets was 0.825. This validates the global scoring scale and demonstrates little difference between the cosmetic and dermatologist approach. Grade Traditional Scoring Scale None 0.5 Barely detectable dryness 1.0 Uniform dryness 1.5 Peeling without cracking 2.0 Moderate cracking 2.5 Moderate cracking with peeling 3.0 Shallow fissuring 3.5 Shallow to deep fissuring 4.0 Deep fissuring Grade Fissuring None 0.5 Barely detectable fine lines 1.0 Mild fissuring (linear cracks) 2.0 Moderate fissuring (shallow) 3.0 Deep fissuring 4.0 Deep fissuring with blood Acknowledgements: Heidi Goldfarb, PhD, Statistics & Data Corporation Zoe Diana Draelos, MD, Dermatologist Elizabeth.Moyer@us.henkel.com or Leslie.Lockhart@us.henkel.com