Protocol I4V-MC-JAIW. A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib in Adult Patients with Moderate to Severe Atopic Dermatitis Save

Date Added
February 27th, 2018
PRO Number
Pro00075349
Researcher
Lara Wine lee

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Keywords
Skin
Summary

This study is to treat patients with moderate to severe atopic dermatitis for whom topical treatments have not been effective. This study will evaluate the safety and efficacy of systemic treatment with baricitinib.
Participation in the study will take about 16 visits over a period of about 26 months.

Institution
MUSC
Recruitment Contact
Abby Powell
843-792-6690
powab@musc.edu

Evaluation of Brentuximab Vedotin for Diffuse Cutaneous Systemic Sclerosis: A Phase 1/2 Multicenter Randomized, Double Blinded, Safety Study Save

Date Added
October 17th, 2017
PRO Number
Pro00070403
Researcher
Richard Silver

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Keywords
Autoimmune disease, Drug Studies, Scleroderma, Skin
Summary

This study is being conducted in order to test the safety of Brentuximab Vedotin in subjects with Diffuse Cutaneous Systemic Sclerosis. The study involves a Screening visit, a Baseline visit and 12 study visits occurring every 3 to 4 weeks, with enrollment lasting approximately 52 weeks, during which enrolled subjects will receive either the study compound or placebo.

Institution
MUSC
Recruitment Contact
Kelley Kajdasz
843-792-5290
gibsonke@musc.edu

Protocol I1F-MC-RHCD Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate Safety, Tolerability, and Efficacy of Ixekizumab in Patients from 6 to Less than 18 Years of Age with Moderate-to-Severe Plaque Psoriasis Save

Date Added
June 27th, 2017
PRO Number
Pro00064844
Researcher
Lara Wine lee

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Keywords
Drug Studies, Pediatrics, Skin
Summary

This is a clinical research trial that will evaluate whether an investigational drug called ixekizumab (given by injection) is safe and effective in children and young adults, ages 6 to 17, with moderate to severe plaque psoriasis. For more information, please call Abby Powell at (843) 792-6690.

Institution
MUSC
Recruitment Contact
Abby Powell
843-792-6690
dermresearch@musc.edu

A Phase 3 Multicenter, Randomized, Double-Blind, Placebo Controlled Study to Determine the Efficacy of Topical SGX301 (Synthetic Hypericin) and Fluorescent Bulb-Light Irradiation for the Treatment of Cutaneous T-Cell Lymphoma Save

Date Added
March 14th, 2017
PRO Number
Pro00063052
Researcher
Dirk Elston

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Keywords
Cancer/Lymphoma, Skin
Summary

The purpose of this study is to test the safety and efficacy (how well the study medication works) of the experimental SGX301 drug in participants with cutaneous T-cell lymphoma in combination with light therapy using standard fluorescent lights.

Institution
MUSC
Recruitment Contact
Adrian Modzik
843-792-8385
dermresearch@musc.edu

A 2-Part Phase 2 Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of BIIB059 in Subjects with Systemic Lupus Erythematosus and Active Skin Manifestations and in Subjects with Active Cutaneous Lupus Erythematosus with or without Systemic Manifestations. Save

Date Added
January 24th, 2017
PRO Number
Pro00059452
Researcher
Dirk Elston

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Keywords
Drug Studies, Lupus, Skin
Summary

Part A of the study is for people who have Systemic Lupus Erythematosus (SLE) and have active skin disease. This study will look at how well different doses of the study drug BIIB059 works in reducing active skin disease and other lupus manifestations in patients with SLE during 24 weeks of treatment. This study will also look at how well patients tolerate the doses of study drug being tested in this study and what happens to the study drug in the body; for example, how long it remains in your blood and how quickly it is removed from your body.

Part B of the study is for people who have active cutaneous lupus erythematosus (CLE) with or without signs of systemic LE. This study will look at how well the study drug BIIB059 works in reducing skin disease in patients with CLE after 4 to 12 weeks of treatment. This study will also look at how well patients tolerate the study drug and what happens to the study drug in the body; for example, how long it remains in your blood and how quickly it is removed from your body.

Institution
MUSC
Recruitment Contact
Abby Powell
843-792-6690
dermresearch@musc.edu

Monitoring and Managing Newly Healed Chronic Leg and Foot Ulcer Skin Temperature: A Cooling Intervention (MUSTCOOL) to Prevent Ulcer Recurrence Save

Date Added
June 2nd, 2015
PRO Number
Pro00043450
Researcher
Teresa Kelechi

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Keywords
Aging, Circulation, Diabetes, Inflammation, Skin, Vascular
Summary

Individuals with venous leg and diabetic foot ulcers often find these ulcers take a long time to heal and when they do, sometimes they come back. These ulcers can be quite painful making it hard to work, sleep and go about one's day to day activities. You will be asked to do a self-care routine of taking the temperature of the skin where the leg or foot ulcer just healed with a special thermometer and applying a small cooling gel patch over this skin. We want to know if this routine will prevent the ulcer from coming back, help you to become more active, and improve the quality of your life.

Institution
MUSC
Recruitment Contact
Margaret Prentice
843 792 4771
prenticm@musc.edu

Safety and Suitability of Dabigatran to Inhibit Thrombin in Scleroderma Save

Date Added
May 19th, 2015
PRO Number
Pro00042421
Researcher
Richard Silver

Silhouette
Keywords
Autoimmune disease, Lung, Scleroderma, Skin
Summary

This is a six month study to test the safety and suitability of dabigatran etexilate for the treatment of scleroderma-related interstitial lung disease.

Institution
MUSC
Recruitment Contact
Kelley Kajdasz
843-792-5290
gibsonke@musc.edu

FOOTFIT Mhealth Physical Activity Intervention for Leg Ulcer Patients Save

Date Added
May 5th, 2015
PRO Number
Pro00043451
Researcher
Teresa Kelechi

Silhouette
Keywords
Aging, Circulation, Exercise, Skin, Vascular
Summary

This study will test a low intensity foot exercise program for people with lower leg ulcers and who have problems with walking to see if it improves the condition of the legs. A small activity monitoring tracker called an accelerometer will be placed on the foot during the exercises that are to be done in the home for about 6 weeks. The tracker sends movement information to a cell phone that lets you and your doctor know about improvements in the foot movements. Better foot movements help condition the muscles and joints and may improve activity such as walking and getting up from a chair.

Institution
MUSC
Recruitment Contact
Darla Howard
864-560-1042
dhoward@srhs.com

The role of Innate Immunity in the Development of Phenotypic Keloid Disease Save

Date Added
June 29th, 2013
PRO Number
Pro00019607
Researcher
Titus Reaves

Silhouette
Keywords
Immune System, Skin, Vitamin D
Summary

Keloid disease predominantly affects African Americans, Hispanics and some Asians. Keloid disease is characterized by an overgrowth of an area of the skin following some injury to that same skin area. It is unknown why this occurs. However, we believe that differences in Vitamin D along with dysfunction in certain immune system receptors can lead to keloid disease. To further understand this process we intend to study the cells (fibroblasts) in the skin that are affected by Vitamin D and examine the specific immune proteins.

Institution
MUSC
Recruitment Contact
Jacqueline Savage
(843) 792-9372; (843) 792-1870
savageja@musc.edu, reaves@musc.edu

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