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FDA details possible regulatory paths for Strata Sciences Optimal Dosing Tech

Strata Skin Sciences (NSDQ:SSKN) said this week it received a response letter from the FDA concerning possible 510(k) clearance paths for its Optimal Dosing Technology initially designed for treating psoriasis, vitiligo and other skin conditions. The Horsham, Penn.-based said the federal watchdog proposed 2 alternative paths, the 1st of which would require a clinical trial to substantiate its potential claims for the device and the 2nd would seek clearance “with no new claims regarding treatment or efficacy.” Strata said that should the company pursue the 2nd option, it would “likely consider initiatives to develop potential proprietary features” for the tech, according to an SEC filing. “The company is assessing the alternatives for proceeding and is considering related costs and the availability of cash resources,” Strata wrote in an SEC filing. The company said that it would have cash to pursue either option, or a combination of the 2, from a proposed conversion of outstanding convertible debentures due 2021. Last January, Strat Skin Sciences said it entered into a $12 million debt restructuring agreement, led by MidCap Financial Trust. The post FDA details possible regulatory paths for Strata Sciences Optimal Dosing Tech appeared first on MassDevice.
Source: Mass Device - Category: Medical Devices Authors: Tags: 510(k) Food & Drug Administration (FDA) Regulatory/Compliance Strata Skin Sciences Source Type: news

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CONCLUSION: The present work has confirmed the close relationship between vitiligo and psoriasis. PMID: 28919796 [PubMed]
Source: Clinical, Cosmetic and Investigational Dermatology - Category: Dermatology Tags: Clin Cosmet Investig Dermatol Source Type: research
World-leading dermatologists and their patients are celebrating huge improvements in the treatment of skin diseases like skin cancer, psoriasis, and acne as theCochrane Skin Group marks its 20th anniversary this week.   The effects of the 120 plus published Cochrane Skin Reviews have been far-reaching and have had real impacts on patient care. These include skin cancer, skin allergies, and acne, blistering diseases, hair disorders like alopecia, fungal infections and psoriasis as well as tropical parasitic disea ses.The group is coordinated by the University of Nottingham ’s Centre of Evidence Based Dermatology ...
Source: Cochrane News and Events - Category: Information Technology Authors: Source Type: news
Recently the phototherapy such as narrowband UVB, excimer light, PUVA and UVA1 is widely used for a variety of skin diseases, including psoriasis, vitiligo, atopic dermatitis and scleroderma due to the efficacy and safty. Several studies have been reported the action spectrum for phototherapy of psoriasis. On the other hand, the wavelength characteristic for phototherapy of scleroderma has not been clarified. Therefore, we investigated about the difference of gene expression by UVA1 irradiation in normal human dermal fibroblast (NHDF) as a first step to reveal the action spectrum for phototherapy of scleroderma.
Source: Journal of Investigative Dermatology - Category: Dermatology Authors: Tags: Photobiology and Pigmentation Source Type: research
Abstract Alopecia areata (AA) is a common autoimmune disease and it is challenging to predict which patients will have severe disease. The purpose of this retrospective study was to identify comorbidities in children enrolled in the National Alopecia Areata Registry. Atopic dermatitis was more common in patients with severe AA than in those with mild disease. The most common autoimmune comorbidities were vitiligo, psoriasis, thyroid disease, and juvenile idiopathic arthritis.
Source: Pediatric Dermatology - Category: Dermatology Authors: Tags: Brief Report Source Type: research
This article is protected by copyright. All rights reserved. PMID: 28872663 [PubMed - as supplied by publisher]
Source: The British Journal of Dermatology - Category: Dermatology Authors: Tags: Br J Dermatol Source Type: research
This article is protected by copyright. All rights reserved.
Source: Photodermatology, Photoimmunology and Photomedicine - Category: Radiology Authors: Tags: Letter to the Editor Source Type: research
This article is protected by copyright. All rights reserved.
Source: British Journal of Dermatology - Category: Dermatology Authors: Tags: Letter to the Editor Source Type: research
ConclusionThe adapted Egyptian Arabic version of Skindex-16 is valid and reliable; it showed that skin problems had a clinically significant impact on QoL in Egyptian patients.
Source: International Journal of Behavioral Medicine - Category: Psychiatry Source Type: research
8-Methoxypsoralen is a widely sold drug in Brazil as handled capsules and creams because it is only industrially available as soft gel capsules of 10 mg. In order to contribute to the quality control of these pharmaceutical forms, a spectrofluorimetric method was implemented and applied for the evaluation of the quality of compounding pharmacies in the state of Rio de Janeiro (Brazil). Solutions of 8-methoxypsoralen prepared in ethanol/water (30:70 v/v) produced fluorescence signals at excitation/emission wavelengths of 305/495 nm. The method presented good precision (relative standard deviation, RSD
Source: Journal of the Brazilian Chemical Society - Category: Chemistry Source Type: research
Authors: Guarneri C, Lotti J, Fioranelli M, Roccia MG, Lotti T, Guarneri F Abstract Helicobacter pylori is a gram-negative, flagellate, microaerophilic bacterium identified for the first time about 30 years ago, as a pathogenic factor of gastritis and peptic ulcer. Soon after, it was linked to several gastrointestinal and extra-gastrointestinal diseases (hematological, cardiovascular, neurological, pulmonary and ocular diseases, obesity, diabetes mellitus, growth retardation and extragastric MALT lymphoma). Association and possible cause-effect correlation with H. pylori infection were suggested in diseases of derm...
Source: Journal of Biological Regulators and Homeostatic Agents - Category: Biomedical Science Tags: J Biol Regul Homeost Agents Source Type: research
More News: Clinical Trials | Psoriasis | Skin | Vitiligo