Abstract

ABSTRACT Introduction Historical art from ancient Egypt and classical Greece, suggest that many women may have removed some or all of their pubic hair. In addition, during the Italian Renaissance nude women were often illustrated without pubic hair. Recently, pubic hair removal, as well as body hair trimming, grooming, manscaping and other removal of bodily hair (torso, arms, chest etc) has often been described as the “new norm”. In one survey, approximately 80% of women, 18-65 years of age have reported that they remove some or all of their pubic hair. In addition, another survey estimated that almost 80% of men shave the area around the penis and scrotum. Also, 43% of men reported a history of shaving in the perinium area. Multiple methods, including, but not limited to; shaving, waxing, plucking, cutting, laser removal, chemical creams, and electrolysis all remove unwanted hair but may also significantly affect skin health and barrier integrity. Little is known on post-shave skin recovery and skin health. A novel post-shave cream product was developed to address skin health for all body parts. The product was designed and formulated with specific ingredients that are compatible with the sensitive skin in the perineum and genital area. Objective This research is a prospective case study which was conducted to assess consumer acceptance and tolerability of a post-shave cream when used by healthy women and men immediately after shaving a diversity of body parts and over the course of four weeks. Methods A post-shave cream was formulated by a multi-disciplinary team including Obstetrician / Gynecologist, Cosmetic Chemist, and Chemical engineer. The formulation delivery system includes a reverse emulsion containing emollients, skin protectants, and moisturizing ingredients, including hyaluronic acid. The novel cream contains technology to allow for immediate and prolonged skin benefits including soothing and moisturization. A consumer in-use case study was performed. This was a single-center consumer in-use case study that was performed at a sexual medicine center by a trained sexual medicine physician. Twenty subjects, 17-65 years old, and in good medical and with no active untreated medical conditions were recruited in the study. Subjects applied the post-shave cream to the body area immediately after shaving and at least once daily for four weeks. At the end of the study, self-assessment questions were completed. A Pearson's chi-squared test was performed on responses to each question. The null hypothesis was that the responses (positive, negative, neutral) were evenly distributed among the 20 patients. The goal was to disprove the null hypothesis at a significance level of *p <0.05. All subjects responded to all questions. Results Twenty subjects, 10 female subjects and 10 male subjects, with an average age of 40.8 +/- 11.8 years completed the consumer in-use case study. Overall, subjects applied the product twice daily to post-shaved skin. Male subjects applied the post-shave cream to their face, penile shaft, chest, scrotum, buttocks, legs, and head. Female subject applied the post-shave cream to their legs/arms, underarms, mons pubis, and vulva. Self-assessment results indicated highly statistically (***p < 0.001) favorable responses for each category: product characteristics, skin feel, and overall satisfaction. Specifically, after 4 weeks: - 100% of subjects responded favorably to “I enjoyed the product aesthetics which include feel, texture, and odor.” - 100% of subjects responded favorably to “The product soothed my skin post shaving.” - 100% of subjects responded favorably to “This product minimized the appearance of skin redness.” - 100% of subjects responded favorably to “I would recommend this product for those that are looking to purchase a post-shave cream.” These results suggest that the post-shave cream helped soothe the skin, reduce the appearance of redness, and improve skin health and barrier. Furthermore, results from subjective tolerability evaluation showed that the post-shave cream yielded no adverse events for any subject by the end of the study. Conclusion This single-center consumer in-use case study supports the hypothesis that the post-shave cream when used immediately after post-shaving and for continuous use up to four weeks achieved consumer acceptance and was tolerable. Consumer acceptance was demonstrated in all self-assessment categories, product characteristics, skin perception, and overall satisfaction. Disclosure Yes, this is sponsored by industry/sponsor: Revision Skincare®

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