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
Abby Powell
843-792-6690
powab@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
Abby Powell
843-792-6690
powab@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 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 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

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

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 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

Silhouette
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

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

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 16 visits over a period of about 26 months.

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

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