EVALUATION OF BIOMARKERS OF ATOPIC DERMATITIS IN PEDIATRIC PATIENTS WHOSE DISEASE IS NOT ADEQUATELY CONTROLLED WITH TOPICAL PRESCRIPTION THERAPIES OR WHEN THOSE THERAPIES ARE NOT MEDICALLY ADVISABLE Save

Date Added
October 31st, 2019
PRO Number
Pro00089271
Researcher
Lara Wine lee

List of Studies

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Keywords
Pediatrics, Skin
Summary

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

This is not a treatment study. This study is only recruiting volunteers who are enrolled into an atopic dermatitis registry known as Pedistad. Participation in this study will involve 6 visits every 12 months over a period of 5 years.The information collected in this study may lead to an improved understanding of atopic dermatitis and may provide healthcare providers with important information for treating atopic dermatitis in the future.

Institution
MUSC
Recruitment Contact
Susannah Wakefield
843-792-8352
dermresearch@musc.edu

A Phase 2, Randomized, Placebo-controlled, Double-blind, Open-label Extension Multicenter Study to Evaluate the Efficacy and Safety of KD025 in Subjects with Diffuse Cutaneous Systemic Sclerosis Save

Date Added
October 22nd, 2019
PRO Number
Pro00089320
Researcher
Richard Silver

List of Studies


Profiles_link
Keywords
Autoimmune disease, Drug Studies, Rare Diseases, Scleroderma, Skin
Summary

KD025 is an investigational medication undergoing testing to determine if it may be effective in the treatment of diffuse systemic sclerosis (skin thickening on more than just the hands). KD025 has previously been tested in graft-versus-host disease, idiopathic pulmonary fibrosis, and psoriasis. It has shown preliminary effectiveness and safety in the treatment of these conditions. This study will randomly assign subjects to one of three treatment groups, 20mg of KD025 twice per day, 20mg of KD025 once per day, and placebo. The study will measure the improvement, stabilization or worsening of your symptoms, such as changes in your fatigue and pain levels, lung function, skin thickness and other patient reported outcomes. The study treatment period will last 1 year. The drug may help mitigate symptoms of systemic sclerosis and thus may be helpful with the disease in study. The population to be enrolled in this study will involve patients diagnosed with systemic sclerosis, diffuse subset, 18 years of age or older.

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

A Phase 2 Randomized, Multicenter, Double-blind, Vehicle-controlled, 12-Week, Safety, Efficacy, and Systemic Exposure Study followed by a 12-Week Open-label Extension of Trifarotene (CD5789) Cream HE1 in Adults and Adolescents with Autosomal Recessive Ichthyosis with Lamellar Scale Save

Date Added
April 23rd, 2019
PRO Number
Pro00086734
Researcher
Lara Wine lee

List of Studies

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Keywords
Drug Studies, Skin
Summary

This is a multi-center study of the safety and effectiveness of an experimental study drug in treatment of subjects diagnosed with moderate to severe lamellar ichthyosis (LI). The investigational cream will be applied to the surface of the skin in an effort to reduce LI symptoms such as dry and cracked skin. Participation in the study will last 12 weeks (approximately 6 visits) with the option to continue for another 12 weeks (approximately 5 visits) for a total study duration of up to 24 weeks in total. Compensation may be provided.

Institution
MUSC
Recruitment Contact
Charnele Handy
843-792-8008
handyc@musc.edu

A Multicenter, Randomized, Double-Blind, Placebo Controlled, Operationally Seamless, Adaptive Phase 2/3 Study to Evaluate the Efficacy and Safety of Baricitinib in Adult Patients with Severe or Very Severe Alopecia Areata Save

Date Added
March 12th, 2019
PRO Number
Pro00085379
Researcher
Lara Wine lee

List of Studies

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Keywords
Skin
Summary

This study is to treat patients with alopecia areata 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 20 visits over a period of about 17 months.

Institution
MUSC
Recruitment Contact
Charnele Handy
843-792-8008
handyc@musc.edu

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

List of Studies

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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
Reshil-Marie Dukes
843-792-0387
dukesre@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

List of Studies

Silhouette
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

Silhouette
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

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