Subjects returned for their first investigator evaluation at week 2. The efficacy assessments revealed significant reductions in baseline skin roughness (23%) and sebum (33%), along with improvements in skin cleanliness (29%), skin dryness (17%), smoothness (28%), softness (29%), and overall appearance (13%). By week 4, the investigator efficacy assessment demonstrated continued reduction in roughness (45%), sebum (69%), redness (15%), and dirt (68%; Figure 2) with improvement in skin dry- ness (37%), moisturization (44%), clarity (16%), smoothness (52%), softness (51%), radiance (17%), and overall appearance (24%). These improvements continued to remain significant at week 8 (P<0.001; Figure 3).
The noninvasive instrumental assessments parallel the inves- tigator and subject evaluations. Cleanliness measurements, which were sticky tapes pressed against the skin and designed to assess retained scale, demonstrated a 24% reduction (P=0.009) in facial skin scale after 8 weeks of use of the regimen. Facial se- bum was reduced by 33% (P<0.001) at 8 weeks. No statistically significant changes were seen in elasticity or corneometry, both measures of skin moisturization. Facial imaging revealed im- provements in pore size/pore count and skin roughness (Figure 4).These findings confirmed that the improvement seen in skin smoothness and softness was not related to enhanced moistur- ization, but rather to improved skin exfoliation.
Two subjects withdrew from the study due to facial stinging and burning. These subjects used the exfoliant scrub too ag- gressively, as determined by the dermatologist investigator. While the magnesium oxide particles produced superior exfo- liation, excessive pressure while rubbing the product over the face can damage the skin barrier, resulting in undesirable skin sensitivity. Careful counseling by the dermatologist is required before embarking on this skincare exfoliation regimen to prevent skin barrier damage.
This research demonstrated that multiple progressive and sus- tained improvements in the appearance and quality of skin can be achieved with a comprehensive cleansing, exfoliating, and oil controlling regimen. No changes in skin water content were observed with either corneometry or elasticity measurements, indicating the absence of a moisturization effect, yet the investigator and subject assessments perceived an improvement in skin softness and smoothness. Cleanliness measurements demonstrated a 24% reduction in facial skin scale, accounting for the smoother, softer skin appearance of the photoaged skin from the 3-step regimen. The initial cleansing step wetted the skin and removed excess sebum through the use of the synthetic detergents, sodium laureth sulfate, and cocamidopropyl betaine. This wetting was necessary to soften the corneocytes for desquamation by the exfoliating skin polish. Mechanical exfoliation was induced by sodium bicarbonate and magnesium oxide particles within the scrub. Finally, chemical exfoliation and oil control are achieved with pads containing salicylic acid, mandelic acid, urea, witch hazel, and Rosa canina (dog rose) fruit exract. The oil control pads also incorporated botanical anti-inflammatory agents Rosa canina fruit (dog rose), Phellodendron amurense bark (amur cork tree), Hordeum distichon (barley), and Camellia sinensis leaf (green tea). The pads also contained Spiraea ulmaria leaf, a natural source of salicylates. Moisturizers are the basis of most anti-aging regimens because they place a film over the skin surface, or deliver transient hy-