Trial Outcomes & Findings for A Study to Evaluate of Cosmetic Benefit of a Moisturising Cream in People With Blemish Prone Skin (NCT NCT03093181)

All the participants were recruited from one center in Brazil.

Out of 205 screened participants,157 participants were enrolled, and 132 participants were randomized. 25 enrolled subjects were not subsequently randomized. Out of 132 randomized participants,1 participant was misallocated to treatment (received "no treatment" instead of "positive control").

A Study to Evaluate of Cosmetic Benefit of a Moisturising Cream in People With Blemish Prone Skin

A blinded, trained and qualified evaluator conducted instrumental measurements of skin moisturization.Measurement of skin moisturization was performed by the electrical capacitance method with a Corneometer CM 865. The measuring principle was based on changes in the capacitance of the measuring head, functioning as a condensator. Between the conductors of the probe an electrical field was built which allows the dielectricity of the stratum corneum to be measured. Because the dielectricity of the skin varies as a function of its water content.The range of hydration level was 0 (as dry as possible)\~120 AU (Arbitrary Unit)(most moist possible).Higher Corneometer values are indicative of improved skin moisturization.

A blinded, trained and qualified evaluator conducted instrumental measurements of skin moisturisation. Measurement of skin moisturisation was performed by the electrical capacitance method with a Corneometer CM 865. The measuring principle was based on changes in the capacitance of the measuring head, functioning as a condensator. Between the conductors of the probe an electrical field was built which allows the dielectricity of the stratum corneum to be measured. Because the dielectricity of the skin varies as a function of its water content. Higher Corneometer values are indicative of improved skin moisturisation.

The baseline and week 8 photographs of all participants were displayed side by side on high resolution, color-calibrated display screen in room with neutral wall colors and standardized lighting and all practical efforts were made to minimize glare. The relative positioning (left and right) of baseline and week 8 photographs were blinded to evaluator and randomized. A technician used randomization schedule to display pair of images to lay evaluator. Lay evaluators judged magnitude of improvement in overall appearance of blemishes using the below criteria: Left=blemishes on left are more obvious than those on the right and Right=blemishes on right are more obvious than those on the left. Layperson ranked both left and right image as follows:1=Better;2=Worse. Odds was calculated from logistic regression including treatment and age stratum effects and exchangeable correlation. Odds=p/(1-p) where p was the probability of event that Week 8 was better than baseline.

Baseline and Week 8 photographs of all participants were displayed side by side on high resolution, color-calibrated display screen in room with neutral wall colors and standardized lighting with minimized glare. Relative positioning (left and right) of baseline and Week 8 photographs were blinded to evaluator and randomized. Lay evaluators ranked magnitude of improvement in overall appearance of blemishes using below criteria: Left=blemishes on left are more obvious than those on right; Right=blemishes on right are more obvious than those on left. Lay evaluator ranking for each image pair was converted into a numerical score based on whether Baseline or Week 8 image was ranked better:0=Baseline image was better than Week 8 image,1=Week 8 image was better than Baseline image. Minimum score 0 corresponded to all baseline images being better than Week 8 images. Maximum score 1 corresponded to all Week 8 images being better than baseline images. Higher scores indicated better results.

A treatment blind, trained and qualified evaluator counted the total number of facial blemishes on the forehead, cheeks and chin of the participants.

A treatment blinded, trained and qualified evaluator conducted instrumental measurements of skin sebum levels. Measurement of skin sebum levels was performed by with a Sebumeter SM 815. The measurement principle of the SM 815 is based on grease spot photometry. The translucent tape of the device is brought into contact with skin and becomes increasingly transparent in response to surface oil. The tape is inserted into the aperture of the device and its transparency measured by light transmission, with increased transmission signifying increased oiliness. The software outputs mass sebum levels as a function of area. Sebumeter measurements were taken in triplicate at the central forehead (above the eyebrows) with the participant lying horizontally, on their back.

The forehead of each participant was thoroughly cleansed by the investigator or designee using cotton pads saturated with 70% Isopropyl Alcohol and, after 5 minutes, the central area of the forehead above the eyebrows was measured in triplicate with a Sebumeter. The same area was measured in triplicate 90 minutes after cleansing. The sebum excretion rate was calculated by the difference in 90th minutes and 5th minute Sebumeter values.