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 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, 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

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 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

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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