A Prospective, Multicenter, Long-Term Study to Assess the Safety and Efficacy of Nemolizumab (CD14152) in Subjects with Moderate-to-Severe Atopic Dermatitis

Date Added
October 29th, 2020
PRO Number
Pro00102620
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

Galderma has begun a study of an investigational drug called nemolizumab as a possible treatment for atopic dermatitis. Participants who had been previously enrolled in nemolizumab AD Phase 3 pivotal study will be eligible to enroll for the long term extension. Patients who have completed their initial 16 week treatment period who do not qualify for the maintenance period will be given the option to enroll immediately into the long term extension study. Additionally, subjects who complete the maintenance periods (week 48 visit) may also be eligible to enroll in the long term extension study.

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

A Social Genomics Model to Explore Loneliness and Systemic Inflammation in an Older Adult Population with Chronic Venous Leg Ulcers.

Date Added
August 28th, 2020
PRO Number
Pro00102546
Researcher
Teresa Kelechi

List of Studies


Keywords
Inflammation, Non-interventional, Psychiatry, Skin
Summary

Chronic venous leg ulcers (CVLUs) affect millions of individuals worldwide, causing considerable suffering, disability and poor quality of life. The objective of this study is to assess stressors, symptoms, and biomarkers associated with lonely and non-lonely adults living with CVLUs. The results from this study are expected to improve our understanding of the mechanisms in the body that are common to loneliness and inflammation and lead towards to the development of a tool that can predict wound healing potential among persons with chronic wounds.

Institution
MUSC
Recruitment Contact
Margaret Prentice
843 792 4771
prenticm@musc.edu

Predictive Chronic Wound Monitor for Healing Assessment via Intelligent Sensor Fusion

Date Added
August 4th, 2020
PRO Number
Pro00100687
Researcher
Teresa Kelechi

List of Studies


Keywords
Inflammation, Pain, Skin
Summary

The purpose of this research study is to find out if a wearable bandage with sensors in it and over a chronic wound can accurately tell if a patient's wound is healing or not. Normally, clinician inspection of the wound along with swab cultures are used to assess the healing status of chronic wounds. This study employs artificial intelligence techniques through deep machine learning to look for predictive modeling of wound healing from wound fluid. 10 participants will be enrolled at the UNC Pardee Wound Healing Clinic in North Carolina, USA.

Institution
MUSC
Recruitment Contact
Margaret Prentice
843 323-5644
prenticm@musc.edu

Innovative Dermatology Real World Data and Research Collaborative

Date Added
June 23rd, 2020
PRO Number
Pro00100084
Researcher
Lara Wine Lee

List of Studies


Keywords
Immune System, Skin
Summary

This is a 2-year, longitudinal, observational study of adult patients (ages 18 and above) being treated for moderate to severe plaque psoriasis.

Patients being prescribed or initiating medical therapy with a new biologic drug (such as risankizumab, guselkumab, brodalumab, tildrakizumab, ixekizumab, adalimumab, etanercept, ustekinumab, secukinumab, certilizumab pegol, infliximab, or apremilast) for the treatment of plaque psoriasis will be eligible for enrollment. The study will be conducted to gather data from enrolled patients' electronic health records, prospective physician-reported information provided by the patients' dermatologists, and information collected from questionnaires and surveys completed by the enrolled patients.

Patients will be screened and enrolled at a regularly scheduled clinic visit. 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, emergency room visits, procedures, and medical costs. Physician reported outcomes will be recorded at regularly scheduled visits. Patients will also be asked to complete patient reported outcome (PRO) surveys and questionnaires to record data regarding demographics, clinical characteristics of psoriatic disease, comorbidities, family history, occupation and lifestyle factors, use of PsO support programs, contact information, concomitant medication use, medication side effects, and symptom characteristics.

During the follow-up period, the research site will prospectively submit the research subjects' medical records approximately every 3 to 12 months, for up to 2 years. Patients will be asked to complete PRO surveys electronically at regular intervals during this follow-up period.

Institution
MUSC
Recruitment Contact
Virginia Barton
843-876-0110
bartonv@musc.edu

A PROSPECTIVE OBSERVATIONAL STUDY OF PATIENTS RECEIVING DUPIXENT® FOR ATOPIC DERMATITIS

Date Added
April 28th, 2020
PRO Number
Pro00095844
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

This registry is observational study about patients who are 12 years or older who have Atopic Dermatitis (AD) that are initiating treatment with DUPIXENT.
Patients will be screened and enrolled at a regularly scheduled clinic visit. During the screening and enrollment period, patients will provide medical history, demographic information, complete patient reported outcome (PRO) surveys and physician assessments. During the follow-up period, patients will complete PRO surveys and physician assessments at regular intervals during this follow-up period. Participation in this study will involve at least 12 visits that will take place over a period of 5 years.

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

Topical treatment for superficial disseminated actinic porokeratosis: A Single-Blinded Comparison Between Lovastatin/Cholesterol and Lovastatin

Date Added
April 7th, 2020
PRO Number
Pro00096259
Researcher
Dirk Elston

List of Studies


Keywords
Drug Studies, Genetics, Inflammation, Pain, Rare Diseases, Skin
Summary

The purpose of this research is to treat disseminated actinic porokeratosis (DSAP) with cholesterol/lovastatin or lovastatin alone. The goal of treatment is to decrease (DSAP) lesions after 12 weeks of treatment and compare which treatment is best.

The study is single-blinded and randomized, meaning the patients will not be told of which treatment they will receive, and the decision of which treatment they will receive will be completely random. The patient will also agree to close up photographs and clinical photographs taken of their disseminated actinic porokeratosis at the initial visit. At weeks 4, 8, and 12, the patients will complete a virtual visit. The subject will take a picture (phone camera/digital camera) of their lesions/skin markings with a measuring instrument. These photos will be shared with the investigators. Physical exam, photographs, and a review of of the subjects medical records will occur in the study. Changes in size, appearance, and pain will be monitored throughout the study.

The possible benefit of joining this study is that the treatment received may be more effective than the other study treatment or than other available treatments for DSAP, although this cannot be guaranteed.

Institution
MUSC
Recruitment Contact
Alan Snyder
9106195832
snydeala@musc.edu

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Subjects with Moderate to- Severe Atopic Dermatitis

Date Added
April 7th, 2020
PRO Number
Pro00096947
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

Galderma has begun a study of an investigational drug called nemolizumab as a possible treatment for atopic dermatitis. Participants will be randomized to receive either Nemolizumab or placebo once every 4 weeks. Both Nemolizumab and Placebo will be given through a subcutaneous injection. At Visit 6 (Week 16), if the study doctor determines the participant is responding to the study treatment the participants will once again be randomized to either receive Nemolizumab and placebo or just placebo. At visit 6, if the participant is not responding to the medication the patient will have a follow up visit and their participation in the study will end.

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

A Prospective Multicenter Randomized Controlled Clinical Study to Investigate the Safety and Effectiveness of RES (Regenerative Epidermal Suspension) Prepared with the RECELL® Device Compared to Standard of Care Dressings for Treatment of Partial-thickness Burns in Infants, Children and Adolescents (Aged 1 – 16 Years)

Date Added
January 13th, 2020
PRO Number
Pro00092124
Researcher
Steven Kahn

List of Studies


Keywords
Adolescents, Pediatrics, Skin, Surgery
Summary

The purpose of the study is to see if use of the RECELL device will help heal your
partial-thickness burn faster and decrease the need for skin grafting compared with a standardized wound dressing. The data collected in this current study will provide additional information about the safety and effectiveness of the RECELL® device for treatment of partial-thickness burns. The duration of each participant will last up to 12 months. Visits will include photograph documentation of the wound and various health assessments.

Institution
MUSC
Recruitment Contact
Jason Hirsch
843-792-8824
hirschj@musc.edu

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

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

List of Studies


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

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

List of Studies


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



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