Prospective, observational, longitudinal study in pediatric patients with moderate to severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not medically advisable

Date Added
December 20th, 2018
PRO Number
Pro00084090
Researcher
Lara Wine Lee

List of Studies


Keywords
Pediatrics, Skin
Summary

This study will assess the features of children, younger than 12 years old, with moderate to severe eczema, also known as atopic dermatitis, when their condition is not adequately controlled with topical therapies (creams or lotions) or when those therapies are not medically advisable.

This is not a treatment study. You and your child will complete questionnaires describing how their condition effects them. Information related to your child's illness will be collected by reviewing their medical chart and by assessments performed by the study team. Participation in this study will involve at least 12 visits that will take place over a period of 10 years.

The information collected in this study may lead to an improved understanding of your child's illness and may provide healthcare providers with important information for treating atopic dermatitis in the future.

Institution
MUSC
Recruitment Contact
Susannah Wakefield
843-792-5935
dermresearch@musc.edu

Medication treatment for Opioid use disorder in expectant Mothers (MOMS): a pragmatic randomized trial comparing extended-release and daily buprenorphine formulations

Date Added
August 27th, 2019
PRO Number
Pro00091146
Researcher
Constance Guille

List of Studies


Keywords
Obstetrics and Gynecology, Pregnancy, Psychiatry, Substance Use, Women's Health
Summary

The primary purpose of this study is to compare extended-release buprenorphine (CAM2038) to buprenorphine placed under the tongue (sublingual) in pregnant women with opioid use disorder to see if CAM2038 is as effective as sublingual buprenorphine. We are looking to recruit pregnant women who are between 18-41 years old; are between 6-30 weeks pregnant and are not planning to terminate the pregnancy; have opioid use disorder, and are enrolled or are planning to enroll in outpatient buprenorphine treatment at The Medical University of South Carolina. Participation in the study would last between 13 and 21 months total with up to between about 63-102 total visits, including weekly medication check visits and research visits.

Institution
MUSC
Recruitment Contact
Savannah Lee
8437920376
leesav@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

Multicenter Phenotype-Genotype Analysis of Vascular Anomalies and Related Syndromes

Date Added
December 24th, 2021
PRO Number
Pro00116848
Researcher
Lara Wine Lee

List of Studies


Keywords
Genetics, Pediatrics, Skin, Vascular
Summary

The purpose of this research study is to develop a better understanding of the cause and natural history of vascular anomalies and related syndromes. This study is being done in order to develop a better understanding of the cause of vascular anomalies in order to to improve care for people who are affected by these anomalies and related syndromes.

This study is being done at the University of Wisconsin-Madison (UW-Madison) and other sites in North America and Europe. A total of about 1000 people will participate in this study. About 20 – 30 people will take part in the study here at the Medical University of South Carolina.

Institution
MUSC
Recruitment Contact
Chelsea Shope
8437549577
shopec@musc.edu

Daily Topical Rapamycin Therapy for the Treatment of Vitiligo

Date Added
March 1st, 2022
PRO Number
Pro00115924
Researcher
Lara Wine Lee

List of Studies


Keywords
Adolescents, Autoimmune disease, Pediatrics, Skin
Summary

In current Dermatology practice, options for vitiligo remain limited. The purpose of this study is to determine if once daily dosed topical rapamycin is effective for the treatment of patients with vitiligo. Participants will apply either 0.1% topical rapamcyin or 0.001% topical rapamycin for six months to a lesion on one side of the body, and topical placebo to a corresponding lesion on the opposite side of the body. The study also aims to evaluate patient satisfaction and identify any adverse effects on these dosing regimens.

Institution
MUSC
Recruitment Contact
Chelsea Shope
8437549577
shopec@musc.edu

The ASCEND Trial: A Multicenter, Double Blinded Vehicle Controlled Study of TMB-001, a Proprietary Isotretinoin Ointment, in the Treatment of RXLI (X-linked) or ARCI (Lamellar) Ichthyosis; Preceded by a Voluntary Maximal Use Study; Both Studies in Subjects 6 Years of Age and Above

Date Added
August 10th, 2022
PRO Number
Pro00120937
Researcher
Lara Wine Lee

List of Studies


Keywords
Adolescents, Drug Studies, Pediatrics, Skin
Summary

This study aims to evaluate the safety and efficacy of isotretinoin ointment (TMB-001 0.05%) in treating subjects > or = to 6 years of age with lamellar ichthyosis, and aims to assess the bodily absorption of the cream across application frequencies. Subjects with ARCI/RXLI will be randomized 2:1, to either receive the TMB-001 0.05% isotretinoin ointment or a vehicle ointment - applied daily - for 3 weeks. Subsequently, dosing will be increased to twice daily for 9 weeks. If significant improvement is observed at the end of the 9 weeks, subjects will be randomized 1:1 to receive the TMB-001 0.05% ointment, either applied daily or twice-daily, for 12 weeks. Prior to the Phase III trial, subjects will have the option to participate in a 14 day treatment period with TMB-001 0.05% - twice daily - followed by continued treatment with TMB-001 0.05% twice daily for 10 weeks.

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

OptIMMize-2: A Phase 3 Multicenter, Single-arm, Open-label Extension Study to Assess the Safety, Tolerability, and Efficacy of Risankizumab in Subjects With Moderate to Severe Plaque Psoriasis Who Have Completed Participation in Study M19-977 (OptIMMize-1)

Date Added
November 17th, 2022
PRO Number
Pro00122906
Researcher
Lara Wine Lee

List of Studies


Keywords
Adolescents, Skin
Summary

This is a Phase 3 multicenter, single-arm, open-label extension (OLE) study designed to investigate the long-term safety, tolerability, and efficacy of risankizumab 150 mg or 55 mg by weight every 12 weeks (Q12W) in the treatment of moderate to severe plaque Ps in eligible subjects who have completed all assessments in Study M19-977 and elect to participate in Study M19-973. The study is comprised of a 216-week treatment period and a follow-up phone call for safety approximately 140 days (20 weeks) after the last dose of study drug.

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

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Assess the Efficacy, Safety and Pharmacokinetics of Lebrikizumab Compared to Placebo in Participants 6 Months to <18 Years of Age with Moderate-to-Severe Atopic Dermatitis

Date Added
December 8th, 2022
PRO Number
Pro00123135
Researcher
Lara Wine Lee

List of Studies


Keywords
Children's Health, Pediatrics, Skin
Summary

This study aims to evaluate the efficacy and safety of lebrikizumab when used in combination with topical corticosteroid (TCS) treatment, compared with placebo, in pediatric participants with moderate-to-severe atopic dermatitis. Participants found to be eligible according to all of the study entry criteria will be randomly assigned in a 2:1 ratio to receive either lebrikizumab or placebo. This study can last up to 32 weeks, with 4 study periods. Screening Period: up to 4 weeks (≤30 days), TCS Standardization Period: 2 weeks, Treatment Period: 16 weeks, Post-Treatment Safety Follow-up Period: 12 weeks.

Institution
MUSC
Recruitment Contact
Mikayla DiDonato
8438762281
didonato@musc.edu

A MULTICENTER, RANDOMIZED, VEHICLE-CONTROLLED, DOUBLE-BLIND, PARALLEL COMPARISON, PROOF-OF-CONCEPT STUDY OF QRX003 LOTION IN SUBJECTS WITH NETHERTON SYNDROME

Date Added
December 20th, 2022
PRO Number
Pro00123486
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

The purpose of this study is to assess the dose dependent safety, tolerability and potential efficacy of QRX003 lotion in subjects with Netherton Syndrome (NS). This is a multi-center, randomized, vehicle-controlled, double-blind, parallel group comparison study of QRX003 lotion in adult subjects 18 years of age or older with NS. Approximately 18 subjects will be enrolled at approximately 7 sites. Subjects will be randomized (1:1:1) to treatment as follows:

1. QRX003 (dipalmitoyl hydroxyproline) lotion, 2% (Low dose)
2. QRX003 (dipalmitoyl hydroxyproline) lotion, 4% (High dose)
3. Vehicle lotion

Subjects will apply the assigned test article once daily in the morning to a designated Treatment Area for 12 weeks. Subjects will attend 5 clinic visits for up to 20 weeks.

Institution
MUSC
Recruitment Contact
Mikayla DiDonato
8438762281
didonato@musc.edu

A PHASE 3 RANDOMIZED, DOUBLE-BLIND, 52-WEEK PLACEBOCONTROLLED, MULTI-CENTER STUDY INVESTIGATING THE EFFICACY, SAFETY, AND TOLERABILITY OF RITLECITINIB IN ADULT AND ADOLESCENT PARTICIPANTS WITH NON SEGMENTAL VITILIGO

Date Added
March 2nd, 2023
PRO Number
Pro00126424
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

Ritlecitinib (PF 06651600) is an investigational drug (referred to as "study drug" from here on) and is being developed as possible study treatment for participants with non segmental vitiligo (both active and stable vitiligo). The study drug will be compared with a placebo to find out if the study drug is better than the placebo for the study treatment of vitiligo. The duration of this study is a maximum of 60 weeks. There will be an initial screening period of 30 days where the study doctor will determine eligibility. If eligible, participants will be randomly assigned to receive the study drug or a placebo during a 52 week study treatment period. At the end of the treatment period, participants will enter a 4 week Follow Up Period.

Institution
MUSC
Recruitment Contact
Tiffany Vereen
843-792-6882
vereent@musc.edu



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