Two randomized, controlled, comparative studies of the stratum corneum integrity benefits of two cosmetic niacinamide/glycerin body moisturizers vs. conventional body moisturizers.

BACKGROUND AND OBJECTIVE: Despite numerous body moisturizers being available, cosmetic xerosis continues to be a leading skin problem for consumers. We performed two 35-day studies to evaluate the ability of a variety of body moisturizers containing various levels of oils/lipids, humectants, as well as other ingredients (e.g., niacinamide) to improve stratum corneum integrity. METHODS: 63 and 58 female subjects were enrolled and randomized in an incomplete block design to six of nine products (eight moisturizers or no treatment control) in studies 1 and 2, respectively. The primary endpoints included visual dryness by a qualified skin grader, skin hydration as measured by Corneometer, and barrier integrity as measured by transepidermal water loss (TEWL). The primary comparisons for the two niacinamide/glycerin moisturizers were to the other six moisturizers and to the no treatment control for each endpoint. RESULTS: The two niacinamide/glycerin moisturizers demonstrated an overall better solution towards rapid and prolonged improvement of cosmetic xerosis due to functional improvement of stratum corneum barrier function compared to no treatment and the other moisturizers tested. CONCLUSIONS: These studies establish the benefit of including niacinamide in a body moisturizer to improve the integrity of the stratum corneum and thus reduce cosmetic xerosis over time.

Patient satisfaction with the benefits of overactive bladder treatment: exploration of influencing factors and development of a satisfaction assessment instrument.

INTRODUCTION: Patient-reported outcome (PRO) instruments are useful for assessing treatment success in patients with overactive bladder (OAB). PROs such as the OAB Questionnaire (OAB-q) and Patient Perception of Bladder Condition (PPBC) focus more on OAB symptoms than satisfaction. We describe the development of the Patient Satisfaction with Treatment Benefit (PSTB) questionnaire, and examine the face, content and criterion validity of this tool in a study of darifenacin treatment in OAB patients who expressed dissatisfaction with prior antimuscarinic therapy. METHODS: The PSTB questionnaire was created based on treatment-related items identified as relevant to OAB patients in exploratory interviews, then refined to comprise an Overall Satisfaction question and 23 items addressing specific treatment benefits using a 5-point Likert scale. The PSTB questionnaire was completed at last visit by 473 patients participating in an open-label, 12-week study of darifenacin treatment. Factors driving Overall Satisfaction were explored by investigating its relationship to PPBC, bladder symptom diaries and specific benefits assessed by the PSTB. RESULTS: At study end, mean Overall Satisfaction score was 3.1, corresponding to "satisfied." Overall Satisfaction correlated strongly with each specific benefit in the PSTB, and with PPBC and OAB symptoms at last visit, but more weakly with change from baseline PPBC/symptoms. Satisfaction at last visit was higher for patients with mild/moderate versus severe problems on baseline PPBC. CONCLUSIONS: Patients' reported satisfaction appears to reflect their current status rather than improvement over time. The PSTB tool may have a place alongside other symptom-based instruments. Further testing is required to validate these findings.