A 5-year Longitudinal Observational Study of Patients Undergoing Therapy for Immune-Mediated Inflammatory Skin Conditions Save

Date Added
December 3rd, 2019
PRO Number
Pro00093832
Researcher
Lara Wine lee

List of Studies

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Keywords
Skin
Summary

This is a 5-year, longitudinal, observational study of adult and pediatric patients (all ages) being treated for Immune-Mediated Inflammatory Skin Conditions. In addition to the study database, a biospecimen repository will be included in order to perform studies on biomarkers of response.

Patients being prescribed medical therapy for IMISC will be eligible for enrollment. Treatment algorithms will follow each site's local standard of care and no specific treatments, assessments, and/or laboratory tests will be dictated by enrollment in the main TARGET-DERM Program. Patients will be screened and enrolled at a regularly scheduled clinic visit. Up to three years of retrospective
medical records from patients who provide consent/assent and meet all inclusion and exclusion criteria will be obtained by the research site. Records will include but will not be limited to: hospitalizations, laboratory reports, clinic notes, telephone contact reports, medication lists, reasons for medication initiation and/or discontinuation, biopsy results, and imaging. Patients may
also be linked to external databases (such as patient support programs). Patients will also be asked to provide biological samples and complete patient reported outcome (PRO) surveys, although participation in these two portions is optional.

During the follow-up period, the research site will prospectively submit the research subjects' medical records approximately every 6 to 12 months, for up to 5 years. Patients/legal representatives ("parent proxy") will be asked to complete PRO surveys at regular intervals during this follow-up period.

Institution
MUSC
Recruitment Contact
Courtney Rowley
843-792-9784
rowle@musc.edu

Double-blind, Randomised, Vehicle-controlled, Phase III, Efficacy and Safety Study with 24-month Open-label Follow-up of Oleogel-S10 in Patients with Inherited Epidermolysis Bullosa Save

Date Added
November 25th, 2019
PRO Number
Pro00093635
Researcher
Lara Wine lee

List of Studies

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Keywords
Skin
Summary

The research study is testing a new investigational treatment for epidermolysis bullosa (EB). Chronic, non-healing wounds are a major source of complications in patients with EB. Both acute and chronic wounds impact the quality of life due to itching, pain, and the need for wound dressing changes. The study treatment is called Oleogel-S10. This clinical study of Oleogel-S10 in patients with inherited EB has been initiated to investigate whether Oleogel-S10 is effective and safe in the long-term use. Oleogel-S10 will be compared with a vehicle gel. The vehicle gel is an identical-looking sunflower-oil?based gel that does not contain any active substance (a placebo). The double-blind treatment phase of this study will last for a duration of 3 months. Afterwards, Oleogel-S10 will be provided for 2 years in the follow-up study. In total, there will be 10 scheduled visits and 1 flexible visit in the course of this study.

Institution
MUSC
Recruitment Contact
Courtney Rowley
843-792-9784
rowle@musc.edu

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

Dermoscopic Features in Infantile Hemangiomas Save

Date Added
October 11th, 2019
PRO Number
Pro00091926
Researcher
Lara Wine lee

List of Studies

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Keywords
Cancer, Cancer/Skin, Healthy Volunteer Studies, Infant, Non-interventional, Pediatrics, Rare Diseases
Summary

The goal of the study is to characterize the features of Infantile Hemangiomas before and after treatment. Certain characteristics of the hemangioma can be seen more clearly with a closer and more resolute image of the lesion (abnormal vessels etc.). Developing a greater understanding of these characteristics? may help clinicians better predict the course of infantile hemangiomas in children.

Specific aim 1: to correlate images seen on dermoscopy with regression of the hemangioma.
Specific aim 2: to provide features that may help to predict a better response to treatment.

Institution
MUSC
Recruitment Contact
Lara Wine Lee
8437922890
Winelee@musc.edu

A Phase 3b Multicenter, Randomized, Double-Blind, Double-Dummy, Active Controlled Study Comparing the Safety and Efficacy of Upadacitinib to Dupilumab in Adult Subjects with Moderate to Severe Atopic Dermatitis Save

Date Added
September 24th, 2019
PRO Number
Pro00090285
Researcher
Lara Wine lee

List of Studies

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Keywords
Drug Studies, Skin
Summary

This is a study of upadacitinib versus dupilimab in adult subjects (18-75 years of age) with moderate to severe atopic dermatitis. The study drug, upadacitinib, is an oral medical that is a tablet taken once a day. Dupilimab is given as an injection under the skin every other week. The subject's participation includes a 35-day screening period, a 24-week double-blind treatment period, and an End of Treatment Follow-up visit 12 weeks after the last injection.

Institution
MUSC
Recruitment Contact
Reshil-Marie Dukes
757-668-0387
dukesre@musc.edu

KPL-716-C201: A Phase 2a/b, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy, Safety, Tolerability and Pharmacokinetics of KPL-716 in Reducing Pruritus in Subjects with Prurigo Nodularis Save

Date Added
August 13th, 2019
PRO Number
Pro00090247
Researcher
Lara Wine lee

List of Studies

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Keywords
Drug Studies, Skin
Summary

The main purpose of this study is to see if taking KPL 716 is effective in relieving itch. The study will also assess whether KPL-716 is effective in improving sleep and quality of life or whether it can promote healing of the skin. This study will compare KPL-716 to a placebo. This study is being done to learn if KPL-716 is an effective and safe treatment for participants with moderate to severe prurigo nodularis experiencing moderate to severe itching. KPL is administered through a subcutaneous injection (shot). Participation in the study will take about 13 visits over a period of 20 weeks.

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

Silhouette
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 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

Silhouette
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

Silhouette
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

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