A Multicenter, Open- Label, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib in Adult Patients with Moderate to Severe Atopic Dermatitis Save

Date Added
January 8th, 2019
PRO Number
Pro00077585
Researcher
Lara Wine lee

List of Studies

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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 12 visits over a period of about 108 weeks.

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

Prospective, observational, longitudinal study in pediatric patients with moderate to severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not medically advisable Save

Date Added
December 20th, 2018
PRO Number
Pro00084090
Researcher
Lara Wine lee

List of Studies

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Keywords
Pediatrics, Skin
Summary

This study will assess the features of children, younger than 12 years old, with moderate to severe eczema, also known as atopic dermatitis, when their condition is not adequately controlled with topical therapies (creams or lotions) or when those therapies are not medically advisable.

This is not a treatment study. You and your child will complete questionnaires describing how their condition effects them. Information related to your child's illness will be collected by reviewing their medical chart and by assessments performed by the study team. Participation in this study will involve at least 12 visits that will take place over a period of 5 years.

The information collected in this study may lead to an improved understanding of your child's illness and may provide healthcare providers with important information for treating atopic dermatitis in the future.

Institution
MUSC
Recruitment Contact
Susannah Wakefield
843-792-5935
dermresearch@musc.edu

Molecular pathogenesis of congenital vascular malformations Save

Date Added
December 13th, 2018
PRO Number
Pro00081757
Researcher
Wenbin Tan

List of Studies

Keywords
Pediatrics, Skin, Vascular
Summary

In this study, we will collect congenital vascular malformation (CVM) tissue samples to examine the vascular and neurological phenotypes in the lesions. We will develop a repository of the remaining CVM samples for our future research which will substantially decrease the need for specimen collections from future CVM subjects. We will also collect blood samples and characterize proteins and RNAs profiles from serum exosomes and metabolites from CVM patients, which will help us to understand the progressive mechanism of CVM.

Institution
Palmetto
Recruitment Contact
Wenbin Tan
803-2163816
wenbin.tan@uscmed.sc.edu

Collaborative, National Quality and Efficacy Registry for Tracking Disease Progression in Systemic Sclerosis (Scleroderma) Patients Save

Date Added
November 20th, 2018
PRO Number
Pro00080285
Researcher
Faye Hant

List of Studies


Profiles_link
Keywords
Autoimmune disease, Non-interventional, Rare Diseases, Scleroderma, Skin
Summary

The goal of this study is to develop an early systemic sclerosis (SSc) registry in the United States (US). A registry is a group of patients that are observed over time. This is a non-interventional study, meaning that they are no study specific medications to take or procedures to undergo. The specific aims include ongoing assessment of the natural history of early SSc patients by capturing and analyzing clinical data, patient reported outcomes, and laboratory data. This is a multi-center study with sites spread across the U.S. This study is funded by the Scleroderma Research Foundation.

Institution
MUSC
Recruitment Contact
Trevor Faith
843-792-8997
faitht@musc.edu

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of BMS-986165 in Subjects with Systemic Lupus Erythematosus Save

Date Added
October 24th, 2018
PRO Number
Pro00077684
Researcher
Eric Zollars

List of Studies


Profiles_link
Keywords
Autoimmune disease, Lupus, Skin
Summary

The purpose of this research study is to measure how well and how safe BMS-986165 is in treating patients with Systemic Lupus Erythematosus (SLE) and to determine the optimal dose level.

Lupus is an autoimmune disease, which means that your immune system not only attacks bacteria and viruses but also attacks your healthy cells and organs, affecting many parts of the body. Lupus can cause fever, joint pain, rash (redness of the skin), sensitivity of the skin to sunlight, as well as other symptoms, and may lead to inflammation and organ damage.

Current treatments for Lupus are mainly drugs that suppress the immune system such as cortisone-like drugs (such as prednisone) and cyclophosphamide (a potent drug sometimes used in treating certain types of cancer), and drugs commonly used to treat or prevent malaria (called antimalarials) such as hydroxychloroquine. Many of these treatments may have serious side effects if used for a long time.

Therefore, there is a need for new and effective treatments for Lupus.

Institution
MUSC
Recruitment Contact
Angela Robinson
843-792-6043
robia@musc.edu

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis Save

Date Added
July 10th, 2018
PRO Number
Pro00079009
Researcher
Edwin Smith

List of Studies


Profiles_link
Keywords
Autoimmune disease, Drug Studies, Inflammation, Scleroderma, Skin, Stage III
Summary

SSc, which also can be called scleroderma, is a rare autoimmune disease. Autoimmune diseases such as SSc make your immune system over-active which causes chronic inflammation. This chronic inflammation leads to scar tissue, or fibrosis, of the skin and some internal organs.

The skin and involved internal organs with chronic inflammation from SSc become scarred over time, which makes them not work as well as they should. Lenabasum may help stop chronic inflammation, and stop scarring from getting worse without lowering the immune system.

This study is currently enrolling subjects who have scleroderma and are 18 years or older. Participation in the study will require you to complete 13 scheduled visits over the course of one year. After the completion of each visit, subjects will be compensated.

Institution
MUSC
Recruitment Contact
Trevor Faith
843-792-4844
faitht@musc.edu

A Phase 3 Randomized, Double-Blind, Multi-Center Long-Term Extension Study Investigating the Efficacy and Safety of PF-04965842 With or Without Topical Medications Administered to Subjects Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis Save

Date Added
June 12th, 2018
PRO Number
Pro00076498
Researcher
Lara Wine lee

List of Studies

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Keywords
Skin
Summary

This study is to test the efficacy and safety of PF-04965842 with or without Topical Medications in subjects aged 12 years and older with moderate to severe atopic dermatitis and a body weight of greater than or equal to 40 kg.

Institution
MUSC
Recruitment Contact
Ricardo Cantu
843-792-8894
cantur@musc.edu

A PHASE 2/3 STUDY INVESTIGATING THE PHARMACOKINETICS, SAFETY, AND EFFICACY OF DUPILUMAB IN PATIENTS AGED ?6 MONTHS TO <6 YEARS WITH SEVERE ATOPIC DERMATITIS Save

Date Added
May 8th, 2018
PRO Number
Pro00074957
Researcher
Lara Wine lee

List of Studies

Silhouette
Keywords
Children's Health, Skin
Summary

This study is being conducted to determine how safe and effective an investigational drug called dupilumab (REGN668) is in reducing the signs and symptoms of eczema. This drug is investigational in that it is not yet approved by government agencies, such as the US Food and Drug Administration (FDA) for the treatment of children. Dupilumab is, however, approved by the FDA for the treatment of AD in adult patients.
Your child's participation in this study will require 8 visits to the study center over 3 months.

As part of this study, your child will have a physical exam, blood testing and an electrocardiogram or electrical testing of the heart performed. They will also be given the study drug (dupilumab).

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

A Phase 3 Randomized, Double-Blind, Placebo- Controlled, Parallel Group, Multi-Center Study to Evaluate The Efficacy And Safety of PF-04965842 Monotherapy in Subjects Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis Save

Date Added
April 24th, 2018
PRO Number
Pro00075670
Researcher
Lara Wine lee

List of Studies

Silhouette
Keywords
Skin
Summary

The purpose of this research study is to compare the effects of the study drug, PF 04965842, with a placebo to find out which is better for treating atopic dermatitis.

Institution
MUSC
Recruitment Contact
Ricardo Cantu
843-792-8894
cantur@musc.edu

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF DUPILUMAB ADMINISTERED CONCOMITANTLY WITH TOPICAL CORTICOSTEROIDS IN PATIENTS, ?6 YEARS TO <12 YEARS OF AGE, WITH SEVERE ATOPIC DERMATITIS Save

Date Added
April 10th, 2018
PRO Number
Pro00075600
Researcher
Lara Wine lee

List of Studies

Silhouette
Keywords
Children's Health, Skin
Summary

This is a clinical research trial that will evaluate whether an investigational drug called dupilumab (given by injection) with corticosteroids is safe and effective in children with severe atopic dermatitis. Participation in the study will take about 13 visits to the clinic and 9 phone calls over a period of about 33 weeks.

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

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