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TONE: A Large, Prospective Post-Approval Study Investigating the Repigmentation of Stable Vitiligo Lesions Using a Point-of-Care Autologous Cell Harvesting Device
Introduction: Vitiligo is a depigmenting autoimmune skin disorder caused by loss of melanocytes, impacting 0.5% to 2% of the global population.1-3 For patients with stable vitiligo, surgery allows for physical transplantation of healthy melanocytes to a lesion lacking functional melanocytes.1,4 A combination approach incorporating vitiligo surgery with pharmacotherapy may be recommended in some patients, as employing multiple modalities can improve repigmentation response.4 A point-of-care Autologous Cell Harvesting Device, FDA-approved for the repigmentation of stable vitiligo lesions, prepares autologous skin cell suspension (ASCS) to be applied onto laser-ablated lesions.5 Previously reported, the randomized, within-subject controlled pivotal trial found that 36% of ASCS-treated lesions achieved ≥80% repigmentation at 24 weeks post-treatment, versus 0% of control lesions.6 Here, we report on TONE, a post-approval trial using this device.
Objective: This multi-center, prospective study was conducted to evaluate repigmentation response following the application of ASCS in patients with stable vitiligo lesions in a large study population.
Methods: Enrolled patients had to have a previous unsatisfactory response to topical treatments or phototherapy, have vitiligo comprising <30% body surface area, and remain on their current use of concomitant vitiligo treatment (if applicable) for the duration of the study. A vitiligous area was identified for laser ablation and ASCS treatment, followed by at-home narrowband ultraviolet-B (NB-UVB) phototherapy. Repigmentation response at 24 weeks post-treatment was assessed by a Central Review Committee of three blinded, independent dermatologists.
Results: A total of 107 patients were treated across 17 U.S. sites (14 in-office, 3 hospital outpatient). Enrolled patients had a mean age of 47 (SD±14.6), and half were female. Most patients had non-segmental vitiligo (n=68, 64%), while 17% (n=18) had segmental vitiligo and 20% (n=21) had focal vitiligo.The majority (n=74, 68%) were White, followed by 14% Asian (n=16), and 4% Black or African American (n=5); 29% (n=32) of patients identified as Hispanic or Latino. Three percent (n=3) of patients were Fitzpatrick type I, with 23% (n=25) type II, 43% (n=46) type III, 20% (n=21) type IV, 9% (n=10) type V, and 2% (n=2) type VI. Fifty-two (49%) patients reported using concomitant medication(s) for their vitiligo throughout the study. At Week-24, 42% (n=42) of assessed treated areas achieved ≥80% repigmentation. No serious or severe device-related adverse events were reported.
Conclusion: These results are consistent with findings previously reported in the randomized controlled pivotal trial.6 This study provides further evidence confirming the safety and effectiveness of ASCS for the repigmentation of stable vitiligo lesions, as demonstrated in a large patient population. A diverse population was represented in the large patient sample with an even distribution of male and female patients, inclusion of various vitiligo sub-types, representation of all Fitzpatrick skin types I-VI, and incorporation of concomitant therapies into the protocol. This diversity among subjects is in-line with reported vitiligo patient population data,3,4 indicating potential for generalizability of study findings in practical real-world applications
Sensformer: Powering the future with digitalized transformers
Transformer digitalization is a critical aspect of the development of a smart grid. Siemens Energy has developed a digital transformer solution called Sensformer, which integrates various sensors, communication interfaces, and data analytics capabilities into the transformer to enable advanced monitoring, diagnostics, and prediction capabilities. This article presents an overview of the Sensformer and its key features. It describes the installation and commissioning process of the Sensformer and the benefits of the technology in terms of improved reliability, efficiency, and safety of power systems. A case study is presented to demonstrate the features of the Sensformer in real-world applications, such as detecting hot spots in transformer windings, predicting transformer ageing, performing DGA and optimizing transformer loading based on real-time condition monitoring. The results show that the Sensformer can significantly enhance the performance and value of transformers and provide a reliable and cost-effective solution for grid digitalization
Sonographically Identified Echogenic Renal Masses Up to 1 cm in Size Are So Rarely Malignant They Can Be Safely Ignored
Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/135692/1/jum2016352323.pd
Ascorbic acid as an effective alternative for treatment of dapsone poisoning in a child: A case report
Dapsone (DDS – Diamino diphenyl sulfone), a sulfonamide derivative acts by inhibiting PABA incorporation into folic acid. It is commonly used in treating skin diseases. Accidental poisoning in children is uncommon. It results in methaemoglobinemia by causing oxidative stress. Principle of treatment relies on treating methemoglobinemia by using reducing agents like methylene blue or ascorbic acid. Due to the long half-life, dapsone provides a continuing oxidative stress that can cause a recurrence of clinically significant methaemoglobinaemia and hence takes long to treat. Ascorbic acid is effective in treating methemoglobinemia associated with dapsone poisoning as demonstrated in this case report of a four and half year old child’s accidental ingestion of dapsone tablets and presenting with cyanosis. The child was managed successfully with ascorbic acid and supportive treatment
In vitro study of some plant extracts against Alternaria brassicae and Alternaria brassicicola
Madhya Pradesh is an important rapeseed-mustard producing state of India contributing nearly of the total production in the country. The present study aims to evaluate the effectiveness of some botanicals viz., Neem, Eucalyptus, Datura, Pudina, Tulsi, Lantana under crude and Forms @ against 10% Alternaria brassicae under in vitro condition by poisoned food technique. Neem and Eucalyptus were also evaluated in the oil forms. Nearly all the tested botanicals found effective against these fungi. Among the crude extract 10 per cent the minimum growth was recorded in Neem followed by Eucalyptus, Tulsi, Lantana, Datura and Pudina. Neem was significantly superior over Tulsi, Lantana, Datura and Pudina but at par with Eucalyptus. Under boil forms the minimum radial growth was also recorded in Neem. The oil extract (Neem and Eucalyptus) were found less effective as compared to crude and boil extracts
Usefulness of the Twinkling Artifact in Identifying Implanted Mesh After Inguinal Hernia Repair
Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/135644/1/jum20113081059.pd
Efficacy of ruxolitinib cream in vitiligo by patient characteristics and affected body areas: Descriptive subgroup analyses from a phase 2, randomized, double-blind trial
To the Editor: Vitiligo is a chronic autoimmune disease resulting in patches of depigmented skin and reduced quality of life. In a randomized, dose-ranging phase 2 study (NCT03099304) in 157 adult patients, the Janus kinase (JAK) 1/JAK2 inhibitor ruxolitinib cream produced substantial repigmentation of facial and total body vitiligo lesions after 24 weeks, with continued improvement through week 52, and was well tolerated.3 Here, we present treatment response subanalyses from the phase 2 trial
Technique and diagnostic utility of saline infusion sonohysterography
The introduction of saline infusion sonohysterography has significantly improved sonographic diagnosis of various endometrial pathologies. This procedure entails instillation of warm saline into the uterine cavity transcervically to provide enhanced visualization of the endometrium during transvaginal ultrasound examination. This article reviews the sonohysterography technique and current utility, as well as the spectrum of imaging features of various endometrial pathologies.Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/135202/1/ijgo5.pd
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