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Cutaneous Lupus Erythematosus clinical trials

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NCT ID: NCT01498406 Terminated - Clinical trials for Cutaneous Lupus Erythematosus

Vitamin D Status, Disease Specific and Quality of Life Outcomes in Patients With Cutaneous Lupus

Start date: December 2011
Phase: Phase 2
Study type: Interventional

Lupus is a disease in which the immune system, which normally fights infection, begins to attack healthy cells in the body. This phenomenon is called autoimmunity and what the immune system attacks is called the autoantigen. Lupus can affect many parts of the body and often affects the skin, with immune cells attacking autoantigens in the skin and causing a rash. This rash is often visible to the public because it tends to occur on sun-exposed areas, for example a patient's face, chest, and arms. For this reason, among others, skin lupus can be a source of disability and poor health related quality of life in many patients with this disease. It is not completely understood why or how someone might develop lupus, however there are likely many reasons which include their genetics and also the kind of environment they live in. One such environmental factor, vitamin D, is more commonly known as a vitamin important for bone health. However, we are learning that vitamin D has effects all over the body, and is also important for a healthy immune system. Low levels of vitamin D have been associated with an increased risk of other autoimmune disorders such as diabetes and multiple sclerosis, and have also been found to be common in skin lupus patients. Vitamin D is made in the skin when it is exposed to the sun, specifically ultraviolet B radiation (UVB). The main source of vitamin D for most people is its production in the skin because the normal American diet is not high in vitamin D. However, patients with skin lupus tend to stay out of the sun because their rash is made worse by sunlight, which is thought to produce more of the autoantigens in the skin attacked by the immune system. Additionally, as skin doctors (dermatologists) we recommend sun protection to skin lupus patients to minimize sun-sensitivity and prevent flares of their skin disease. However we may be putting them at risk for low vitamin D status and even more severe disease. Another risk factor that puts skin lupus patients at risk for vitamin D deficiency is that these patients generally have darker skin types which blocks UVB and further limits vitamin D production in the skin. Given that skin lupus patients are at high risk for low vitamin D status as mentioned above, the investigators propose a research study that will provide information about vitamin D levels in these patients. The investigators seek to identify how many skin lupus patients have low vitamin D status and how vitamin D influences the natural history of this skin disease. Additionally the investigators will evaluate whether or not supplementation with high dose vitamin D will lessen the severity and negative quality of life impact of skin lupus. Supplementation of vitamin D by mouth is an inexpensive, well tolerated, and safe over the counter method to replete and maintain a normal vitamin D status. Studies in other autoimmune diseases, specifically Crohn's disease and multiple sclerosis, have shown that high dose vitamin D supplementation improves disease severity. It is the hope of the investigators that this will also be observed in skin lupus patients. In summary, the investigators seek to move beyond establishing an association between vitamin D status and skin lupus. The investigators aim to elucidate the therapeutic benefit, if any, of vitamin D status on disease severity and quality of life while controlling for important factors that may influence vitamin D status. If the investigators are to show improvement in disease severity with vitamin D supplementation, this would be a cost-effective additional therapy to our standard clinical practice. Future research would also allow us to investigate other alternative markers of vitamin D deficiency and disease activity in skin lupus patients, a population at high risk for low vitamin D status and in need of further research.

NCT ID: NCT01470313 Terminated - Clinical trials for Cutaneous Lupus Erythematosus

A Multiple Dose Study Of PD-0360324 In Patients With Active Cutaneous Lupus Erythematosus

Start date: November 2011
Phase: Phase 1
Study type: Interventional

This study is designed to evaluate the safety and tolerability of multiple intravenously administered doses of PD-0360324 in patients with cutaneous lupus erythematosus. Changes in disease activity will also be evaluated.

NCT ID: NCT01300208 Completed - Clinical trials for Cutaneous Lupus Erythematosus

To Evaluate the Preliminary Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of CC-11050 in Subjects With Discoid Lupus Erythematosus and Subacute Cutaneous Lupus Erythematosus

Start date: October 1, 2010
Phase: Phase 2
Study type: Interventional

This is the first study in cutaneous lupus erythematosus subjects to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of CC-11050.

NCT ID: NCT01146444 Completed - Clinical trials for Cutaneous Lupus Erythematosus

Sunscreens in Patients With Cutaneous Lupus Erythematosus(CLE)

Start date: November 2009
Phase: N/A
Study type: Interventional

Part I: to investigate the efficacy of different sunscreens in the prevention of skin lesions following standardized photoprovocation with Ultraviolet A/Ultraviolet B (UVA/UVB) light in patients with CLE. Part II: to evaluate the influence of different sunscreens on the expression of biomarkers in the skin of patients with CLE and of Healthy Controls following UV irradiation.

NCT ID: NCT00523588 Completed - Clinical trials for Cutaneous Lupus Erythematosus

Treatment of Cutaneous Lupus Erythematosus (CLE) With the 595 nm Flashlamp Pulsed Dye Laser

Start date: March 2007
Phase: Phase 2
Study type: Interventional

The purpose of using the 595 nm Vbeam Perfectaâ„¢ flashlamp-excited, pulsed dye laser in this study is to help improve study patients' skin disease. Cutaneous lupus erythematosus (CLE) often presents with disfiguring vascular lesions which are frequently difficult to treat with the available therapeutic measures, such as photoprotection, topical steroids, and antimalarials. Laser therapy provides an alternative treatment option for CLE patients. Although there has been documented experience with laser treatment in CLE patients, no study comparing treated lesions to the natural course of the disease has been conducted.

NCT ID: NCT00470912 Completed - Skin Lesion Clinical Trials

Sunscreen RV 2457C in Photoinduced CLE

Start date: May 2001
Phase: Phase 3
Study type: Interventional

Lupus erythematosus (LE) is characterized by a large clinical spectrum, and sunligt is a well established factor in the induction and exacerbation of this disease. In all subsets of LE, skin lesions occur preferentially in sun-exposed areas. Previous studies have demonstrated that the lesions in LE patients reproduced in controlled experimental conditions. The initial reports suggested that the action spectrum for the LE was in the UVB range (290 to 320 nm), but more recent studies have demonstrated that UVA (320 to 400 nm) can contribute to the induction of LE skin lesions. Antimalarial agents and topical steroids are the main treatments of chronic LE. The second line therapies include retinoids, sulfones, immunosuppressor agents, systemic corticosteroid and thalidomide. Moreover, patients are advised to avoid sun, to wear sunprotective clothing and to apply sunscreen. The aim of this study was to assess the efficacy of a sunscreen milk with high protection factor against UV-B and UV-A, used exclusively, in the photoinduced LE.

NCT ID: NCT00420173 Completed - Clinical trials for Cutaneous Lupus Erythematosus

Interdisciplinary Study Group of Lupus Erythematosus (ISGLE)

Start date: September 2004
Phase: N/A
Study type: Observational

Cutaneous lupus erythematosus (CLE) is a disease with a wide spectrum of clinical manifestations and a variable prognosis. The aim of this study is to create a standardized evaluation of the different subtypes of this disease in order to receive an overview of the spectrum of clinical and laboratory features as well as the therapeutic strategies for patients with CLE.

NCT ID: NCT00317681 Completed - Clinical trials for Cutaneous Lupus Erythematosus

Efficacy of Topical Tacrolimus in Different Subtypes With Cutaneous Lupus Erythematosus (CLE)

Start date: August 2005
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy of topical tacrolimus in different subtypes of cutaneous lupus erythematosus. As shown by several groups activated memory T lymphocytes play a key role in the pathogenesis of lupus erythematosus. Tacrolimus targets T lymphocytes and suppresses their activation by inhibiting the expression of cytokine genes, such as IL-2. Therefore, treatment of cutaneous lupus erythematosus with topical tacrolimus might result in an improvement of skin lesions in such patients.