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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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Aditya Maitray, Pukhraj RishiIndian Journal of Ophthalmology 2017 65(11):1243-1245Psoralen compounds such as methoxsalen are photosensitizer agents used in conjunction with ultraviolet A (UVA) radiation exposure as photochemotherapy (Psoralens and ultraviolet-A therapy [PUVA therapy]) for certain epidermal skin disorders such as psoriasis and vitiligo. Methoxsalen has been shown to be associated with premature cataract formation by forming adducts with lens proteins following oral administration and subsequent UVA exposure. Hence, the use of UV-filtering glasses is recommended during PUVA therapy sessions. Ocular tissues c...
Source: Indian Journal of Ophthalmology - Category: Opthalmology Authors: Source Type: research
Conditions:   Psoriasis;   Cutaneous T Cell Lymphoma;   Lymphoproliferative Disorders;   Eczema;   Lichen Planus;   Prurigo;   Pruritus;   Polymorphic Light Eruption;   Graft Vs Host Disease;   Mastocytosis;   Vitiligo Intervention:   Other: Photo(chemo)therapy Sponsor:   Medical University of Graz Recruiting
Source: ClinicalTrials.gov - Category: Research Source Type: clinical trials
This study was conducted on 10 patients with psoriasis, 10 patients with vitiligo and 10 controls. JAK1 levels before and after treatment with NB-UVB 311  nm (36 sessions) were measured using Western blot assay. The level of JAK1 was significantly higher in vitiligo and psoriasis patients than controls. There was a decline in the level of JAK1 after treatment, which was statistically significant. VASI and PASI scores of patients decreased after trea tment with NB-UVB. In psoriatic patients, the JAK1 level positively correlated with the female participants, disease duration and PASI change. It was concluded that JAK1 p...
Source: Archives of Dermatological Research - Category: Dermatology Source Type: research
Conclusions CSU patients have an increased risk of AIDs, especially adult female patients with a positive family history and a genetic predisposition for AIDs, who should be screened for signs and symptoms of AIDs.
Source: Autoimmunity Reviews - Category: Allergy & Immunology Source Type: research
AbstractVitamin D plays a key role in skeletal and cardiovascular disorders, cancers, central nervous system diseases, reproductive diseases, infections, and autoimmune and dermatological disorders. The two main sources of vitamin D are sun exposure and oral intake, including vitamin D supplementation and dietary intake. Multiple factors are linked to vitamin D status, such as Fitzpatrick skin type, sex, body mass index, physical activity, alcohol intake, and vitamin D receptor polymorphisms. Patients with photosensitive disorders tend to avoid sun exposure, and this practice, along with photoprotection, can put this categ...
Source: American Journal of Clinical Dermatology - Category: Dermatology Source Type: research
AbstractAutoimmune liver diseases, which include mainly autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, and the variant syndromes, are often associated with extrahepatic autoimmune diseases. However, the association with cutaneous diseases is less well described. In the present article, we provide a systematic literature review on skin manifestations linked to each of these four autoimmune liver diseases, excluding skin manifestations of systemic diseases. The association of autoimmune hepatitis with vitiligo is well known, with a particular striking association with type 2 autoimmune hep...
Source: Clinical Reviews in Allergy and Immunology - Category: Allergy & Immunology Source Type: research
Immunonology IG Seminar The skin is a barrier organ that is a frequent site of entry for numerous pathogens. The skin is able to resist infection through a variety of mechanisms including innate and adaptive immune responses. Resident memory T cells (TRM) are a recently appreciated subset of memory T cells that reside in the skin and are required for optimal protection against previously encountered pathogens. These cells also participate in a number of cutaneous autoimmune diseases including vitiligo, psoriasis and alopecia areata. The skin also contains several populations innate immune cells that provide pathogen protec...
Source: Videocast - All Events - Category: General Medicine Tags: Upcoming Events Source Type: video
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
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