The average age of the included subjects was 57.8 years (SD: 12.3; Range: 18 to 75), with no statistical difference between the average age between male and females in the study (P>0.05).
Diabetes Type
The majority of subjects had a diagnosis of DM2 (82.6%) compared with DM1 (17.4%), and the relative ratio of DM1 and DM2 did not vary based on gender (X2 = 0.22, P=0.64).
The most common areas with xerosis where the study skincare products were used included legs (~76%), feet (~58%), arms (~56%), and hands (~50%). The average number of affected areas per subject was 6.1 (SD: 3.3; Range: 1 to 16) (Table 3).
Subject Compliance to Study Treatment
Subjects reported being compliant with 91.60% of the study product applications. Over 80% (n = 441/528) of subjects reported being fully compliant with the twice-daily application regimen throughout the study duration. No AEs were reported to be possibly or probably related to the study products used for the duration of the study.
The Primary Efficacy Endpoint Scores
The physician-assessed GAIS scores at week 4 showed that 519 (98.3%) subjects met the primary efficacy endpoint (scoring at least an improved skin condition) (Figure 1). As per the GAIS scores, the global appearance of xerosis did not worsen in any subject.
Physician Dry Skin Classification Scale Scores
All parameters of the physician-scored DSCS significantly (P<0.001) improved from baseline to EOS (Table 4). From the physicians' DSCS scores, a post hoc analysis was done to show the percentage of subjects that presented with each of the parameters at baseline who had at least a 1-point improvement comparing baseline vs EOS (Figure 2A). Figure 2B shows the percentage of subjects with each parameter at baseline with 1-point up to 4-point improvement, no change, or scored worse at EOS.
Subject Dry Skin Classification Scale Scores
The post hoc analysis for subject DSCS scores showed that roughness/scaling, itchiness, pain, erythema, and fissure scores significantly (P<0.001) improved by week 4 (Table 5) for subjects that presented with each of the parameters at baseline. Figure 3A shows the percentage of subjects that presented with each of the parameters at baselines who had at least a 1-point
