A Phase 3, Multicenter, Open-Label Extension Study of the Long-Term Safety of ARQ-151 Cream 0.15% and ARQ-151 Cream 0.05% in Subjects with Atopic Dermatitis

Date Added
June 17th, 2021
PRO Number
Pro00110858
Researcher
Lara Wine Lee

List of Studies


Keywords
Adolescents, Children's Health, Skin
Summary

This study is being done to evaluate the long term safety of ARQ-151 cream 0.15% and ARQ-151 cream 0.5% in subjects with mild to moderate eczema (atopic dermatitis). Eligible subjects will enroll in the long term safety study after they have successfully completed the preceding study. Study medication will be applied topically for 52 weeks at home. All affected areas, except on the scalp, will be treated. For the first 4 weeks of study, all subjects will apply study medication once a day in the areas identified and treated during the preceded study. Beginning at the Week 4 visit, any subject who achieves vIGA-AD of ‘0-clear' as confirmed by the Investigator at a scheduled or unscheduled clinic visit, will switch to twice weekly (BIW) maintenance treatment. For maintenance therapy, study medication will be applied on two nonconsecutive days per week.

Institution
MUSC
Recruitment Contact
Lauren Parsons
(843) 792-1436
parsonla@musc.edu

A LONG-TERM STUDY TO ASSESS THE SAFETY AND EFFICACY OF LEBRIKIZUMAB IN PATIENTS WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS

Date Added
June 7th, 2021
PRO Number
Pro00106868
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

Dermira, Inc./ Eli Lilly and Company has begun a study of an investigational drug (also known as the "study drug") called lebrikizumab as a possible treatment for moderate-to-severe atopic dermatitis. Patients who successfully complete the first Lebrikizumab study will be eligible for this study. This study will last approximately 62 weeks, and you will need to come to the study center at least 8 times over this period. The study is divided into 2 time periods: a Treatment Period and a Follow up Period. During the treatment period, participants will be given Lebrikizumab ever 2 weeks or every 4 weeks but all participants will receive injections every 2 weeks. During each study period, you will have 1 or more visits with your study doctor at the study center. All visits will last about 1 to 2 hours.

Institution
MUSC
Recruitment Contact
Nicholas Ciappa
843-792-6280
ciappa@musc.edu

A Phase 3, 4-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-151 Cream 0.15% Administered QD in Subjects with Atopic Dermatitis

Date Added
May 11th, 2021
PRO Number
Pro00108253
Researcher
Lara Wine Lee

List of Studies


Keywords
Adolescents, Children's Health, Skin
Summary

This study is being done to evaluate the safety and efficacy of ARQ-151 cream in subjects with mild to moderate eczema (atopic dermatitis) after application once every day for a month. Results will be compared against a vehicle (placebo). The vehicle is a dummy drug made from the same base product used to make ARQ-151 cream, but it does not contain any active study drug. ARQ-151 is a cream that contains the active ingredient roflumilast. Roflumilast is marketed in Canada, the United States, and other countries as a tablet (pill taken by mouth) for flares of a specific chronic lung disease. You will apply the study drug on your eczema lesions once a day for 28 days. The study doctor will tell you which lesions to treat. Any newly appearing eczema lesions that arise during the study must also be treated.

Institution
MUSC
Recruitment Contact
Alyson Winter
843-876-3209
wintera@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

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, 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

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



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