148 research outputs found

    Salicylic Acid Peel Incorporating Triethyl Citrate and Ethyl Linoleate in the Treatment of Moderate Acne: A New Therapeutic Approach.

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    BACKGROUND: Acne affects many adolescents. Conventional therapy often results in side effects and poor adherence, and the treatment does not consider the psychological effect of acne on patients, which is comparable with that of disabling diseases. OBJECTIVES: To evaluate the efficacy and tolerability of a peel (30% salicylic acid, triethyl citrate and ethyl linoleate) combined with a home therapy with three topical agents (triethyl citrate, ethyl linoleate and salicylic acid 0.5% cream, lotion) in moderate acne of the face. DESIGN: Prospective, observational, multicenter, open-label, postmarketing, phase IV study. METHODS: Patients were assessed by comparing Global Acne Grading System (GAGS) score and total lesion count from 15 days before the first peel (T-15 ), after four salicylic peels (every 10 ± 2 days (T0 , T10 , T20 , T30 ), and 20 days after of the end of the study (T50 ). This treatment was associated to a home therapy. RESULTS: Fifty-three patients completed the study. The average GAGS score fell 49% between T-15 and T50 (p < .001). No patient withdrew for adverse events. CONCLUSIONS: This therapy was effective and well-tolerated in all cases. Chemo-exfoliation sessions ensured the continuous monitoring of clinical results and improved patient quality of life

    Editorial: Children's Exercise Physiology

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    Publisher's version (útgefin grein)Stimulated by the need to understand the specific effects of exercise on children, the current Frontiers Research Topic was carried out to collect a set of studies that highlight important findings related to the impact of exercise in this population. Childhood is a very specific and sensitive period for a great number of characteristics that are a part of human development. Among them, motor and functional changes, supported by growth (nature) and experience (nurture) play a key role in the performance trajectories of current and future development of children’s physical fitness, motor competence, and physical activity behavior (Rodrigues et al., 2016) with relevance to future health profiles in adulthood (WHO, 2010; ODPHP, 2018). Exercise physiology research in this specific population has not always been a major concern, probably because maximal performance and competitive sports are not the intended targets in childhood; nonetheless, it is crucial to better understand children’s aptitudes and to define exercise guidelines and optimization. That is why we expect that this Frontiers Research Topic on children’s exercise physiology will help to boost the science and practice in childhood exercise and training. With 20 articles published in this Research Topic, six main areas of research were defined:(a) performance, (b) physical fitness, (c) motor skill and fundamental motor competence, (d)measurement methodologies, (e) overweight subjects, and (f) pathological subjects. Most of the articles examined consider these areas of research. Based on the diversity of study designs and objectives, we now have the opportunity to better understand the mechanisms that explain the effects of exercise on children and how performance and health can be mediated by different covariates. It is not easy or straightforward to attribute an area to each article published in our Research Topic, though we have tried to do so. We have also summarized the most noteworthy evidence of each study."Peer Reviewed

    HIDRAdisk: validation of an innovative visual tool to assess the burden of hidradenitis suppurativa

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    Background Hidradenitis suppurativa (HS) is a chronic, relapsing, inflammatory skin disease characterized by painful inflamed nodules, recurrent abscesses and fistulas located in apocrine gland–bearing body sites. The negative impact of HS on patient's quality of life (QoL) has been reported to be greater than other dermatologic conditions as psoriasis and atopic eczema, and its improvement is an important goal in disease management. Nowadays, there are no specific validated QoL instruments available for HS and generic dermatologic questionnaires are used. Objective The objective of this study was to demonstrate the validity, reliability and responsiveness of HIDRAdisk, a new innovative tool designed for rapid assessment of HS burden and, at the same time, an intuitive graphic visualization of the measurement outcome. Methods A multicentre, longitudinal, observational study was conducted to validate the HIDRAdisk compared with other validated questionnaires [Skindex‐16, Dermatology Life Quality Index (DLQI), Work Productivity and Activity Impairment–General Health (WPAI:GH)] and to evaluate its correlation with disease severity in Italian patients with any degree of HS severity, as measured by Hurley stage and HS Physician Global Assessment (HS‐PGA). Results A total of 140 patients (59% women; mean age 34.9 ± 11.0 years) were enrolled in 27 dermatologic centres. HIDRAdisk showed a strong correlation with Skindex‐16 and DLQI, and a good one with WPAI:GH (correlation coefficient: 0.7568, 0.6651 and 0.5947, respectively) and a statistically significant correlation with both Hurley stage and HS‐PGA. Very good internal consistency (Cronbach coefficient &gt;0.80; intraclass correlation coefficient &gt;0.6), with correlation between the 10 items, good test–retest reliability (Spearman correlation coefficient, 0.8331; P &lt; 0.0001) and responsiveness to changes were demonstrated. Conclusion Our study shows that HIDRAdisk, a short and innovative visual HS QoL instrument, has been psychometrically validated in Italian language and it may help improve the management of HS once implemented in routine clinical practice

    HIDRAdisk: validation of an innovative visual tool to assess the burden of hidradenitis suppurativa

    Get PDF
    Background Hidradenitis suppurativa (HS) is a chronic, relapsing, inflammatory skin disease characterized by painful inflamed nodules, recurrent abscesses and fistulas located in apocrine gland–bearing body sites. The negative impact of HS on patient's quality of life (QoL) has been reported to be greater than other dermatologic conditions as psoriasis and atopic eczema, and its improvement is an important goal in disease management. Nowadays, there are no specific validated QoL instruments available for HS and generic dermatologic questionnaires are used. Objective The objective of this study was to demonstrate the validity, reliability and responsiveness of HIDRAdisk, a new innovative tool designed for rapid assessment of HS burden and, at the same time, an intuitive graphic visualization of the measurement outcome. Methods A multicentre, longitudinal, observational study was conducted to validate the HIDRAdisk compared with other validated questionnaires [Skindex‐16, Dermatology Life Quality Index (DLQI), Work Productivity and Activity Impairment–General Health (WPAI:GH)] and to evaluate its correlation with disease severity in Italian patients with any degree of HS severity, as measured by Hurley stage and HS Physician Global Assessment (HS‐PGA). Results A total of 140 patients (59% women; mean age 34.9 ± 11.0 years) were enrolled in 27 dermatologic centres. HIDRAdisk showed a strong correlation with Skindex‐16 and DLQI, and a good one with WPAI:GH (correlation coefficient: 0.7568, 0.6651 and 0.5947, respectively) and a statistically significant correlation with both Hurley stage and HS‐PGA. Very good internal consistency (Cronbach coefficient &gt;0.80; intraclass correlation coefficient &gt;0.6), with correlation between the 10 items, good test–retest reliability (Spearman correlation coefficient, 0.8331; P &lt; 0.0001) and responsiveness to changes were demonstrated. Conclusion Our study shows that HIDRAdisk, a short and innovative visual HS QoL instrument, has been psychometrically validated in Italian language and it may help improve the management of HS once implemented in routine clinical practice

    Efficacy and safety of Velmanase alfa in the treatment of patients with alpha-mannosidosis: results from the core and extension phase analysis of a phase III multicentre, double-blind, randomised, placebo-controlled trial

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    Introduction This phase III, double-blind, randomised, placebo-controlled trial (and extension phase) was designed to assess the efficacy and safety of velmanase alfa (VA) in alpha-mannosidosis (AM) patients. Methods Twenty-five patients were randomised to weekly 1 mg/kg VA or placebo for 52 weeks. At study conclusion, placebo patients switched to VA; 23 patients continued receiving VA in compassionate-use/follow-on studies and were evaluated in the extension phase [last observation (LO)]. Co-primary endpoints were changes in serum oligosaccharide (S-oligo) and in the 3-min stair-climb test (3MSCT). Results Mean relative change in S-oligo in the VA arm was −77.6% [95% confidence interval (CI) −81.6 to −72.8] at week 52 and −62.9% (95% CI −85.8 to −40.0) at LO; mean relative change in the placebo arm was −24.1% (95% CI −40.3 to −3.6) at week 52 and −55.7% (95% CI −76.4 to −34.9) at LO after switch to active treatment. Mean relative change in 3MSCT at week 52 was −1.1% (95% CI −9.0 to 7.6) and − % (95% CI −13.4 to 6.5) for VA and placebo, respectively. At LO, the mean relative change was 3.9% (95% CI −5.5 to 13.2) in the VA arm and 9.0% (95% CI −10.3 to 28.3) in placebo patients after switch to active treatment. Similar improvement pattern was observed in secondary parameters. A post hoc analysis investigated whether some factors at baseline could account for treatment outcome; none of those factors were predictive of the response to VA, besides age. Conclusions These findings support the utility of VA for the treatment of AM, with more evident benefit over time and when treatment is started in the paediatric age

    Comprehensive long-term efficacy and safety of recombinant human alpha-mannosidase (velmanase alfa) treatment in patients with alpha-mannosidosis

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    Introduction Long-term outcome data provide important insights into the clinical utility of enzyme replacement therapies. Such data are presented for velmanase alfa in the treatment of alpha-mannosidosis (AM). Methods Patient data (n = 33; 14 adults, 19 paediatric) from the clinical development programme for velmanase alfa were integrated in this prospectively-designed analysis of long-term efficacy and safety. Patients who participated in the phase I/II or phase III trials and were continuing to receive treatment after completion of the trials were invited to participate in a comprehensive evaluation visit to assess long-term outcomes. Primary endpoints were changes in serum oligosaccharide and the 3-minute stair climb test (3MSCT). Results Mean (SD) treatment exposure was 29.3 (15.2) months. Serum oligosaccharide levels were significantly reduced in the overall population at 12 months (mean change: –72.7%, P < 0.001) and remained statistically significant at last observation (−62.8%, P < 0.001). A mean improvement of +9.3% in 3MSCT was observed at 12 months (P = 0.013), which also remained statistically significant at last observation (+13.8%, P = 0.004), with a more pronounced improvement detected in the paediatric subgroup. No treatment-emergent adverse events were reported leading to permanent treatment discontinuation. Conclusions Patients treated with velmanase alfa experienced improvements in biochemical and functional measures that were maintained for up to 4 years. Long term follow-up is important and further supports the use of velmanase alfa as an effective and well-tolerated treatment for AM. Based on the currently available data set, no baseline characteristic can be predictive of treatment outcome. Early treatment during paediatric age showed better outcome in functional endpoints
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