A Phase 2b/3, Randomized, Double-Blind, Placebo-Controlled, 2-Arm, Efficacy, and Safety Study in Prurigo Nodularis with Nalbuphine ER Tablets for Pruritus Relief Through Itch Scratch Modulation (PRISM Study) Save

Date Added
January 22nd, 2019
PRO Number
Pro00080319
Researcher
Lara Wine lee

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Keywords
Skin
Summary

This international study will enroll males and females age 18 years and older who have been diagnosed with prurigo nodularis. The study involves an oral experimental (investigational) drug, called nalbuphine ER, that is being tested for the treatment of prurigo nodularis. Regularly scheduled visits to the study center will be required (approximately 15) and participation is expected to last up to 60 weeks. Compensation will be provided for participants.

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

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-controlled Study to Assess the Efficacy and Safety of Apremilast (CC 10004) in Pediatric Subjects from 6 through 17 Years with Moderate to Severe Plaque Psoriasis Save

Date Added
January 22nd, 2019
PRO Number
Pro00084118
Researcher
Lara Wine lee

List of Studies

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Keywords
Drug Studies, Pediatrics, Skin
Summary

The purpose of this study is to test and compare the effects of an investigational (being tested) drug called apremilast to placebo in pediatric plaque psoriasis.
Participants who are determined to be eligible to participate will be assigned by chance (or randomized) to treatment with apermilast or placebo. At Week 16, participants will receive apremilast regardless of treatment group. Study and safety assessments, including questionnaires and blood draws, will be completed at study visits. The maximum amount of time participants will be in the study is 71 weeks (at least 19 visits).

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

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

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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

Spironolactone for the treatment of melasma: a prospective, open-label proof-of-concept and dose-ranging study Save

Date Added
December 4th, 2018
PRO Number
Pro00076765
Researcher
Dirk Elston

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Profiles_link
Keywords
Drug Studies, Skin
Summary

The purpose of this study is to evaluate if the drug spironolactone - which is used to treat acne and male pattern hair growth in women - is effective in treating melasma in females and which dose of the drug works the best. Participation in this study will take about 5 clinic visits over approximately 16 weeks and the option to continue for longer if desired.

Institution
MUSC
Recruitment Contact
Den Lynch
843-876-5074
lynchd@musc.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

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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

AN OPEN-LABEL EXTENSION STUDY TO ASSESS THE LONG-TERM SAFETY AND EFFICACY OF DUPILUMAB IN PATIENTS ?6 MONTHS TO <18 YEARS OF AGE WITH ATOPIC DERMATITIS Save

Date Added
November 13th, 2018
PRO Number
Pro00076016
Researcher
Lara Wine lee

List of Studies

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Keywords
Children's Health, Skin
Summary

This is a clinical research trial that will evaluate whether an investigational drug called dupilumab (given by injection) is safe and effective in children with severe atopic dermatitis.

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

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