Incisional negative pressure wound therapy for preoperatively irradiated lower extremity soft tissue sarcoma wounds. A prospective randomized clinical trial.

Date Added
August 18th, 2015
PRO Number
Pro00028423
Researcher
Lee Leddy

List of Studies


Keywords
Cancer, Cancer/Sarcoma, Infectious Diseases
Summary

This is a study comparing two methods of dressing a post operative wound that are currently in practice. One method is a traditional dry gauze dressing. The other method is using a negative pressure dressing that provides gentle suction on the wound.

We will attempt to determine how well the use of post-operative negative pressure dressing reduces wound healing problems in patients who have surgery after radiation for a sarcoma in the thigh or leg.

Institution
MUSC
Recruitment Contact
Robert McClam
843 8462210
McClam, Grayson (mcclamr@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)

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

List of Studies


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

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

List of Studies


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

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

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

List of Studies


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 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

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

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

Identification of Molecular and Genetic Variations Underlying Skin Diseases

Date Added
November 3rd, 2020
PRO Number
Pro00096209
Researcher
Lara Wine Lee

List of Studies


Keywords
Cancer, Genetics, Infectious Diseases, Inflammation, Rare Diseases, Skin
Summary

Genetic changes to human skin contribute to a wide variety of conditions and diseases that affect over 20% of the population. However, the genes and molecules that are responsible for human skin development and disease are not fully understood, preventing the development of treatment options. This proposal seeks to better understand one disease in particular, linear morphea, a form of Sclerederma that can affect the skin, muscle, and bone. This study will recruit subjects to collect and use skin tissue for the purpose of identifying the genetic causes of linear morphea.

Institution
MUSC
Recruitment Contact
Alexandra Ritter
757-777-6673
ritteral@musc.edu

A Phase 3, 16-week, Randomized, Double-Blind, Placebo-Controlled, Parallel- Group Study to Assess the Impact of Lebrikizumab on Vaccine Responses in Adult Patients with Moderate-to-Severe Atopic Dermatitis

Date Added
March 1st, 2021
PRO Number
Pro00107871
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

Eli Lilly and company has begun a study of an investigational drug called Lebrikizumab as a possible treatment for moderate-to-severe atopic dermatitis (AD). This study will also include 2 vaccines commonly used in adults with moderate-to-severe AD: meningococcal vaccines (MCV) and tetanus, diphtheria, and pertussis (Tdap). The main purpose of this study is to learn whether Lebrikizumab could impact how effective certain vaccines may be and how effective and safe the study drug is in patients with moderate-to-severe AD compared with placebo. A placebo is an inactive material that looks like the study drug but does not contain any active study drug. The study duration is approximately 32 weeks, and participants will need to come to the study center at least 7 to 11 times over this period.

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

Using a Cold Atmospheric Plasma Device to Treat Molluscum Contagiosum and Verruca Vulgaris in Pediatric Patients

Date Added
May 4th, 2021
PRO Number
Pro00106689
Researcher
Lara Wine Lee

List of Studies


Keywords
Children's Health, Pediatrics, Skin
Summary

This study is going to test a cold atmospheric plasma device (CAP), in particular a floating electrode-dielectric barrier device (FE-DBD), to treat warts and molluscum. The treatment device in this study generates cold atmospheric plasma (gaseous ionized molecules) to rid the virus from the body. Based on the successes of previous dermatologic studies, FE-DBD is being tested for this study to treat warts and molluscum. Patients will be enrolled to test the efficacy and safety of this device. 

Patients aged between 4-21 years are eligible to participate. The duration of the study is 4-12 weeks depending on treatment clearance. The number of lesions will be chosen by the dermatologist. Patients will receive standard of care therapy and/or NTAP depending on the number of lesions. Safety profile and patient tolerability will be measured, as well as changes in size, pain and appearance. Photographs and clinical impression will be used to measure treatment response. Pain and tolerability will be assessed by a visual analogue scale and tolerability assessment scale.

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



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