Prospective study comparing pain difference between ice and lidocaine/epinephrine during tangential shave biopsy.

Date Added
April 29th, 2021
PRO Number
Pro00106291
Researcher
Hesham Alshaikh

List of Studies

Keywords
Skin
Summary

Shave biopsy are arguably the single most valuable diagnostic option to dermatologist. It provides a quick, cost effective and efficient means of diagnosing skin lesions for treatment purposes. Patients are typically anesthetized with lidocaine/epinephrine before biopsy. Needle phobia and the burning sensation experienced with lidocaine/epinephrine makes biopsies very uncomfortable for many patients. This leads to the question, does the painful, anxiety inducing shot offset the pain of the superficial shave biopsy?

For this study we will be using the visual pain scale to measure total amount of pain experienced after tangential skin biopsy with lidocaine/epinephrine versus tangential skin biopsy with topically applied ice cubes. Two lesions of comparable dermatomes will be selected on each patient. The control will be the standard of care anesthetic (1% lidocaine w/epinephrine 1:100,000) and the intervention will be ice cubes without lidocaine/epinephrine. We will be holding the plastic wrapped ice on the skin for approximately 30s before the tangential biopsy. The patient will be asked to complete anxiety assessment (prior to the procedure) and pain assessment (after the biopsy) in response to lidocaine/epi and ice. Assessments will be completed for each arm (control and intervention arm).

Institution
MUSC
Recruitment Contact
Hesham Alshaikh
843-792-3021
alshaikh@musc.edu

Weekly Sirolimus Therapy for the Treatment of Venous and Lymphatic Malformations

Date Added
April 6th, 2021
PRO Number
Pro00106369
Researcher
Alexandra Ritter

List of Studies

Keywords
Adolescents, Pediatrics, Skin, Vascular
Summary

In current practice, options for venous and lymphatic malformations remain limited. Recently an oral medication, sirolimus, has been found to benefit patients when taken once or twice a day for several months. Unfortunately there are many side effects associated with this medication, some of which can be severe including, neutropenia, oral ulcerations, and lab abnormalities. The purpose of this study is to determine if once weekly dosed sirolimus will be effective for the treatment of venous and lymphatic malformations. Additionally, the study will evaluate patient satisfaction and identify adverse effects. Participants will be on the medication for 6 months with an option to continue after this time period.

Institution
MUSC
Recruitment Contact
Alexandra Ritter
7577776673
ritteral@musc.edu

A Proof of Concept, Split Study, Measuring the Effectiveness of Topical ProstaglandinF2alpha, Microneedling and Excimer Laser in the Treatment of Vitiligo.

Date Added
March 2nd, 2021
PRO Number
Pro00104695
Researcher
Joni Mazza-McCrann

List of Studies


Keywords
Cosmetic Procedures, Drug Studies, Ethnicity and Disease, Skin
Summary

The purpose of this research is to treat vitiligo with topical PGF2α, microneedling and excimer laser. The goal is to have greater repigmentation than the standard of care (excimer) after 12 weeks of treatment.

The study is a pilot, split study meaning the patient will receive one experimental and one standard of care treatment on symmetric lesions of similar location, geometrics and size.

Enrolled subjects will present biweekly to clinic for twelve weeks. One lesion will be treated with microneedling, topical PGF2α and calibrated excimer laser, while the parallel lesion will be excimer laser alone. Physical exam, photographs, and a review of of the subjects medical records will occur in the study. Changes in size, appearance, and adverse events will be monitored throughout the study. The patient will also agree to close up photographs of their lesions 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 then other available treatments for vitiligo, although this cannot be guaranteed.

Institution
MUSC
Recruitment Contact
Gabriella Santa Lucia
7244138833
grs200@musc.edu

A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Bimekizumab in Study Participants with Moderate to Severe Hidradenitis Suppurativa

Date Added
November 17th, 2020
PRO Number
Pro00102631
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

The purpose of this study is to help us understand how safe and effective a new drug called bimekizumab is for long-term use in treating hidradenitis suppurativa. Bimekizumab is a new drug that may eventually be used in the treatment of hidradenitis suppurativa. It is investigational, which means that is it still being tested, and has not yet been approved for treatment by the health authorities, such as the US Food and Drug Administration (FDA). Bimekizumab acts on the immune system to help reduce inflammation and other symptoms. In this study, bimekizumab is administered in three different dosing regimens. Among 490 study participants, 420 of them will be receiving bimekizumab (140 study participants under each dose of bimekizumab) and 70 of them will be receiving placebo for the first 16 weeks.

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

Identification of Molecular and Genetic Variations Underlying Skin Diseases

Date Added
November 3rd, 2020
PRO Number
Pro00096209
Researcher
Colleen Cotton

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

Weekly Isotretinoin Therapy for the Treatment of Moderate Acne Vulgaris

Date Added
November 3rd, 2020
PRO Number
Pro00103493
Researcher
Samantha Karlin

List of Studies

Keywords
Drug Studies, Skin
Summary

In current Dermatology practice, options for moderate acne remain limited. The mainstay of treatment for moderate acne remains long courses of oral antibiotics despite emerging antibiotic resistance. The efficacy of daily to twice daily dosed isotretinoin, an oral vitamin A derivative, for treatment of moderate-severe acne has been well established. The purpose of this study is to determine if once weekly dosed isotretinoin is effective for the treatment of patients with moderate acne. Participants will be on this dosing of isotretinoin for four months, with the option to continue after this time period. Additionally, the study aims to evaluate patient satisfaction and identify any adverse effects on this alternative dosing regimen.

All clinic visits and laboratory tests will be performed per standard of care while on the medication. The most common side effects of isotretinoin are dry skin, dry lips, dry eyes, and potential discomfort from blood draws, but there are rarer reported side-effects. Alternative treatments options include topical medications alone, oral antibiotics, and for females, oral contraceptive pills and oral spironolactone. There may be costs for participation in this study.

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

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.

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



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