Background: FMX101 4% topical minocycline foam has been shown to be an effective and safe treatment for acne vulgaris (AV).Objective: To further evaluate the efficacy and safety of FMX101 4% in treating moderate to severe acne vulgaris.Methods: A 12-week, multicenter, randomized (1:1), double-blind, vehicle-controlled study was conducted. Coprimary end points were the absolute change in inflammatory lesion count from baseline and the rate of treatment success (Investigator's Global Assessment score of 0 or 1 with a $2-grade improvement).Results: There were 1488 participants in the intent-to-treat population. The FMX101 4% group had significantly greater reductions in the number of inflammatory lesions from baseline (P \ .0001) and a greater rate of treatment success based on Investigator's Global Assessment (P \ .0001) versus the foam vehicle group at week 12. FMX101 4% was generally safe and well tolerated.
Limitations:The efficacy and safety of FMX101 4% were not characterized in participants with mild AV.Conclusion: FMX101 4% topical minocycline foam was effective and safe for the treatment of moderate to severe AV.
This work was aimed to study the activity of topical products formulated with Helianthus annuus normal and ozonized oil produced in Italy, Recent studies have suggested a possible moisturizing and elasticizing activity of Helianthus Annuus ozonized oil. For such characteristics Helianthus Annuus ozonized oil appears an appropriate ingredient to be used in topical preparations for the treatment of skin hydration. The oil was incorporated into O/W emulsion in a standard formulation at percent concentration of 3%, 5% and 10 % respectively of Helianthus Annuus normal and ozonized oil, one O/W emulsion was prepared without active ingredient as control. The investigation was carried out on 10 healthy female volunteers, between the ages of 20 and 40, with normal or dry skin. Each product was applied to the volar surface of the forearm at a dose of 3 mg/cm 2 . As control, the same cream without active ingredient was applied to the other forearm. To evaluate TEWL and skin elasticity, was used the device Aveal 220 (Sylton diagnostic systems). The skin hydration action of the emulsions was evaluated in relation to basal value, and the emulsion without active ingredient, respectively after 15 minutes and 8 days. The skin elasticity was evaluated after 15 minutes and 8 days. The results showed that the 6 emulsions with Helianthus Annuus normal and ozonized oil, compared to the emulsion without active, significantly increase the degree of hydration and elasticity of the skin. The 10% formulation of Helianthus Annuus ozonized oil has a greater power of hydration of the skin compared to other emulsions, both short and long term and is the emulsion that has produced better results.
The prevalence of TV in vaginal and urethral smears indicates the significant incidence of trichomoniasis in STD. TV was more frequently isolated in patients with clinically manifested infection. TV susceptibility to MND was tested in vitro in aerobic and anaerobic conditions. The resistance of strains under in vitro conditions did not correlate with refractory feature of trichomoniasis to MND application [7, 17, 18]. The success of trichomoniasis treatment depends upon multiple factors, including: a) TV susceptibility to drug, b) intravaginal redox potential, c) drug concentration in situ, d) associated microorganisms that may modify the amount of the drug available in situ [7, 18, 21]. The results of our investigation argue for the latter item, verifying that TV resistance to MND is higher in patients with polyinfection in relation to those with monoinfection (significant difference, chi 2 = 18.270; p < 0.01). Repeated administration of low metronidazole doses may prolong the therapy of trichomonas infections, while application of high doses (over 3 g/day) may result in undesired complications. Given the well-known fact that repeated sublethal doses induce the resistance, would it be more beneficial to begin with slightly higher metronidazole dose (3 g/day) during short period of time (3-5 days)? This will be the subject of our further investigation.
The number of clinical trials conducted in patients with atopic dermatitis is increasing steadily. These trials are conducted in several countries across all continents and include patients of different ethnicity, race and skin color. This diversity is desired, but it also brings challenges, including the diagnosis and evaluation of disease severity in patients with different skin colors; the influence of ethnicity on the perception of quality of life and patient reported outcomes; the inclusion of ethnicities that are only present in one country or that live far from clinical research sites; and the reporting of drug safety information. There is a need to better train physicians on the evaluation of atopic dermatitis in patients with different skin colors and a need to improve the systematic reporting of ethnicity, race and skin color in clinical trial publications.
The characteristics of modern society contribute to a condition we call Cultural Stress Anxiety Syndrome (CSAS), which is a response to the constant, pervasive, ever-increasing stress of modern living. Cultural Stress often leads to an isolated, sedentary lifestyle and a state of constant anxiety that triggers the body’s inflammation response, including the release of stress hormones linked to weight gain. Because Cultural Stress aggravates all other causes of obesity, it must be included in any effective weight management program. We present a review of the factors implicated in the obesity epidemic, as well as the implications of chronic stress on a variety of health issues. We then outline the evidence for Cultural Stress as a phenomenon that compounds other stressors, as well as the societal factors most responsible for Cultural Stress. We report on an initial pilot study that focuses on Cultural Stress-reduction as part of an inclusive health management program. We conclude that Cultural Stress is a factor in virtually all of the conditions that contribute to obesity: higher stress hormones, disrupted sleep, sedentary lifestyle, isolation, and reduced self-esteem. Supporting patients in managing Cultural Stress empowers them to effectively reduce their weight and maintain that weight loss over time.
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