Study Population
Men or women aged 18 to 75 years diagnosed with DM-related xerosis were enrolled. Excluded were subjects with a history of allergy, anaphylaxis, allergic contact dermatitis, or hypersensitivity to any ingredients in the CERs-containing cleanser and moisturizing cream. Further excluded were those with atopy and other skin disorders that may have affected assessments or results of using the study products.
Study Visits and Assessments
The 3 study visits occurred as follows: screening (day -30 to 0), baseline (day 0), end of study (EOS) (day 28 ± 5 days). Visits 1 and 2 could be combined to occur on the same day. Table 1 shows the scales used for assessment and the scoring schedule. Physicians and subjects used the Dry Skin Classification Scale (DSCS) to score skin roughness or scaling, skin pruritus, pain, erythema, and fissures on a 5-point scale at baseline and at EOS.8 The Global Aesthetic Improvement Scale (GAIS) was scored by the physicians at EOS. The subject scored QoL aspects at baseline and EOS. Subject satisfaction with treatment outcomes, skincare use, cleanser, and moisturizer performance was scored at EOS. Finally, safety was assessed by monitoring AEs during all study visits.
Statistical Considerations
The intent-to-treat (ITT/safety) population comprised all properly enrolled subjects. The per-protocol (PP) analysis included all enrolled subjects who met all inclusion and exclusion criteria, received study products, completed all visits within the specified window, completed assessments, and had no significant protocol violations that would affect the treatment evaluation. Safety analysis was performed on the ITT population [N = 531].
Efficacy analyses were performed on the ITT and PP populations, with ITT as the primary population and PP supportive. The primary efficacy endpoint was the physician-assessed GAIS (the frequency of subjects having at least improved condition) at the EOS.
IBM SPSS Statistics was applied for statistical analysis. The data were assessed for parametric or nonparametric distribution. Scaled variables are displayed as means +/- SD, and categorical variables are indicated by frequency tables or cross-tabulations.
The Mann-Whitney U test or the chi-squared test was used to evaluate the quantitative variables. For all analyses, significance (P-value) was set to <0.05.
A post hoc power analysis was conducted using G*Power,9-11 with N = 528, a small effect size set at 0.2, and an α error probability of 0.05, 2-tailed, which revealed a power (1 - β) of 0.99 in detecting statistically significant group differences (baseline vs day 28 +/- 5 days) in the DSCS, at the 0.05 level.
Men or women aged 18 to 75 years diagnosed with DM-related xerosis were enrolled. Excluded were subjects with a history of allergy, anaphylaxis, allergic contact dermatitis, or hypersensitivity to any ingredients in the CERs-containing cleanser and moisturizing cream. Further excluded were those with atopy and other skin disorders that may have affected assessments or results of using the study products.
Study Visits and Assessments
The 3 study visits occurred as follows: screening (day -30 to 0), baseline (day 0), end of study (EOS) (day 28 ± 5 days). Visits 1 and 2 could be combined to occur on the same day. Table 1 shows the scales used for assessment and the scoring schedule. Physicians and subjects used the Dry Skin Classification Scale (DSCS) to score skin roughness or scaling, skin pruritus, pain, erythema, and fissures on a 5-point scale at baseline and at EOS.8 The Global Aesthetic Improvement Scale (GAIS) was scored by the physicians at EOS. The subject scored QoL aspects at baseline and EOS. Subject satisfaction with treatment outcomes, skincare use, cleanser, and moisturizer performance was scored at EOS. Finally, safety was assessed by monitoring AEs during all study visits.
Statistical Considerations
The intent-to-treat (ITT/safety) population comprised all properly enrolled subjects. The per-protocol (PP) analysis included all enrolled subjects who met all inclusion and exclusion criteria, received study products, completed all visits within the specified window, completed assessments, and had no significant protocol violations that would affect the treatment evaluation. Safety analysis was performed on the ITT population [N = 531].
Efficacy analyses were performed on the ITT and PP populations, with ITT as the primary population and PP supportive. The primary efficacy endpoint was the physician-assessed GAIS (the frequency of subjects having at least improved condition) at the EOS.
IBM SPSS Statistics was applied for statistical analysis. The data were assessed for parametric or nonparametric distribution. Scaled variables are displayed as means +/- SD, and categorical variables are indicated by frequency tables or cross-tabulations.
The Mann-Whitney U test or the chi-squared test was used to evaluate the quantitative variables. For all analyses, significance (P-value) was set to <0.05.
A post hoc power analysis was conducted using G*Power,9-11 with N = 528, a small effect size set at 0.2, and an α error probability of 0.05, 2-tailed, which revealed a power (1 - β) of 0.99 in detecting statistically significant group differences (baseline vs day 28 +/- 5 days) in the DSCS, at the 0.05 level.
RESULTS
Sixty-two sites in 19 countries within 6 continents (Asia, Africa, North America, South America, Europe, and Australia) participated in the study (Table 2). A total of 531 subjects completed the study. Three subjects were excluded from the analysis due to incorrect enrollment (ie, the subjects met at least one exclusion criteria at baseline). The final sample available for data analyses was N = 528.
The active data collection phase of the study required 326 days to be completed.
The active data collection phase of the study required 326 days to be completed.
