A Phase 3, Double-Blind, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream Followed by a Long-Term Safety Extension Period in Children (Ages ≥ 2 Years to < 12 Years) With Atopic Dermatitis

Date Added
November 16th, 2021
PRO Number
Pro00115393
Researcher
Lara Wine Lee

List of Studies


Keywords
Children's Health, Skin
Summary

The purpose of this research study is to determine if an investigational cream, ruxolitinib cream (0.75% and 1.5% strengths), is safe and effective to treat Atopic Dermatitis. In this study, ruxolitinib cream will be compared to a "vehicle cream." The vehicle cream looks like the ruxolitinib cream but contains no ruxolitinib. This study can last up to 55 weeks. For the first 8 weeks participants will be randomly assigned to receive either the ruxolitinib cream or vehicle cream. For the following 44 weeks participants will receive the ruxolitinib cream.

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

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects with Non-Segmental Vitiligo

Date Added
September 21st, 2021
PRO Number
Pro00111604
Researcher
Lara Wine Lee

List of Studies


Keywords
Drug Studies, Skin
Summary

The purpose of this study is to test and compare the effects of an investigational drug called Upadacitinib versus placebo in adults aged 18 to 65 with a diagnosis of non-segmented vitiligo. Participants that meet eligibility criteria will be randomized into 1 of 5 treatments groups for a period of 24 weeks. At week 24, participants who were randomized to placebo will be switched to either 22 or 11 mg upadacitinib in a blinded fashion, while those receiving the drug will remain in their randomized treatment at week 24. This will be a 28 week blinded long-term extension.

Institution
MUSC
Recruitment Contact
Lauren Parsons
8437921436
parsonla@musc.edu

A Randomized, Active-Controlled, Efficacy Assessor-Blinded Study to Evaluate Pharmacokinetics, Safety and Efficacy of Risankizumab in Patients from 6 to Less than 18 Years of Age with Moderate to Severe Plaque Psoriasis

Date Added
September 14th, 2021
PRO Number
Pro00111592
Researcher
Colleen Cotton

List of Studies

Keywords
Children's Health, Drug Studies, Pediatrics, Skin
Summary

The purpose of this study is to test and compare the effects of investigational drug risankizumab to the active control, ustekinumab, on pediatric plaque psoriasis. Subjects that meet all eligibility criteria will be randomized 2:1 to receive 150 mg dose of risankizumab and 45mg or 90 mg dose of ustekinumab - both drug dosages are determined by weight. At Week 16, subjects receiving ustekinumab or are unresponsive to risankizumab, will be switched to or continue to receive 150 mg risankizumab every 12 weeks. Subjects that are responsive to risankizumab at Week 16, will be re-randomized 1:1 to continue risankizumab or withdrawal from the study drug. Subjects randomized to withdrawal will receive no study drug until a flare occurs, after which they will enter a 16-week re-treatment period.

Institution
MUSC
Recruitment Contact
Alyson Winter
8438763209
wintera@musc.edu

Fibrotic Mechanisms in Systemic Sclerosis

Date Added
August 17th, 2021
PRO Number
Pro00111928
Researcher
Deanna Baker Frost

List of Studies


Keywords
Autoimmune disease, Skin
Summary

We plan to obtain skin biopsies from patients with systemic sclerosis and grow cells from biopsies. With those cells, we will use them in experiments to see why the cells from systemic sclerosis patients have more fibrosis compared to patients without systemic sclerosis.

Institution
MUSC
Recruitment Contact
Deanna Baker Frost
8437928461
bakerde@musc.edu

A PHASE 3B, MULTI CENTER, OPEN-LABEL LONG-TERM EXTENSION STUDY OF APREMILAST (CC-10004) IN PEDIATRIC SUBJECTS FROM 6 THROUGH 17 YEARS OF AGE WITH MODERATE TO SEVERE PLAQUE PSORIASIS

Date Added
July 13th, 2021
PRO Number
Pro00105940
Researcher
Lara Wine Lee

List of Studies


Keywords
Children's Health, Skin
Summary

The purpose of this study is to evaluate the long-term safety of apremilast in children and adolescents (ages 6 though 17). Pediatric subjects, who have completed Week 52 (end of Apremilast Extension Phase) in study CC-10004-PPSO-003 are eligible to enroll in this study. Apremilast will be provided in bottles throughout the entire study. Apremilast will be provided as 20 or 30 mg tablets, based on body weight category, by the study sponsor, Amgen Inc. and will be taken orally twice daily, approximately 12 hours apart.

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

A Phase 3, 4-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-151 Cream 0.05% Administered QD in Subjects with Atopic Dermatitis

Date Added
July 6th, 2021
PRO Number
Pro00111522
Researcher
Colleen Cotton

List of Studies

Keywords
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
Lauren Parsons
843-792-1436
parsonla@musc.edu

A Phase 1/2a, Controlled, Randomized, Multicenter Study Evaluating the Efficacy, Safety, Tolerability of StrataGraft Skin Tissue Overlay of Meshed Autograft (SOMA) in Treatment of Full-Thickness Thermal Burns

Date Added
July 6th, 2021
PRO Number
Pro00109484
Researcher
Steven Kahn

List of Studies


Keywords
Skin, Surgery
Summary

The objective of this study is to evaluate the efficacy of augmenting traditional autografting with Stratagraft. Stratagraft is a synthetic human-tissue based regenerative skin device, which was designed to decrease the amount of donor tissue needed to treat severe burn wounds. Patients who participate in this study are asked to complete assessments, such as wound photography, wound healing progression, and scar progression, at multiple timepoints during a 1 year period.

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

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 Prospective Multi-Arm Blinded Evaluator Within-subject Randomized Controlled Clinical Study to Investigate the Safety and Effectiveness of RECELL for the Repigmentation of Stable Vitiligo Lesions

Date Added
May 24th, 2021
PRO Number
Pro00107906
Researcher
Steven Kahn

List of Studies


Keywords
Cosmetic Procedures, Skin, Surgery, Transplant
Summary

This is a randomized study to evaluate the clinical performance of RECELL for re-pigmentation of stable, de-pigmented skin in subjects 18 years or older. RECELL is a device that takes a small sample of skin from one location on the participant's body, processes that sample into a spray, and then applies that spray to the depigmented skin on the participant's body. Each participant will have some depigmented skin that is not treated by the RECELL device, so that a comparison can be made to the treated areas. The participant will be asked to return for a follow-up visit 1, 4, 12, 24, 36, and 52 weeks after their treatment, so that the research study team can assess their outcome.

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



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