Cold Atmospheric Plasma Device for the Treatment of Molluscum Contagiosum and Verruca Vulgaris in Pediatric Patients - Open-Label Extension Study

Date Added
June 6th, 2023
PRO Number
Pro00127338
Researcher
Lara Wine Lee

List of Studies


Keywords
Children's Health, Pediatrics, Skin
Summary

Patients between 4-21 years of age with at least one wart or molluscum lesion are eligible to participate in this study. The duration of the study is a minimum of 4 weeks with the maximum duration of monthly treatments for one year, depending on lesion clearance. The number of lesions will be chosen by the dermatologist. Patients who opt to participate will receive non-thermal, or cold, atmospheric plasma to treat all lesions selected. Safety profile as well as changes in size, pain and appearance will be measured. Photographs and dermatologist impressions will be used to measure treatment response.

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

A Phase 3, Multicenter, Long-Term Extension Study to Assess the Safety and Efficacy of Lebrikizumab in Participants 6 Months to <18 Years of Age with Moderate-to-Severe Atopic Dermatitis

Date Added
June 19th, 2023
PRO Number
Pro00128287
Researcher
Lara Wine Lee

List of Studies


Keywords
Children's Health, Skin
Summary

This Phase 3 study is designed to assess the long-term safety and efficacy of lebrikizumab in participants 6 months to <18 years of age with moderate-to-severe AD. Participants who have completed Study KGBI through Week 16 without requiring the use of systemic rescue medication will be eligible to enroll into Study KGBJ. All participants will receive active lebrikizumab treatment during Study KGBJ. The planned duration of treatment for each participant is approximately 52 weeks. All participants will enter a post-treatment safety follow-up period approximately 12 weeks after the last dose of lebrikizumab. This study will include both on-site (in clinic) and remote visits (telephone calls).

Institution
MUSC
Recruitment Contact
Mikayla DiDonato
843-876-2281
didonato@musc.edu

A Phase 3, Double-Blind, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream in Participants With Prurigo Nodularis

Date Added
August 2nd, 2023
PRO Number
Pro00128776
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

The purpose of this research study is to determine if an investigational cream, ruxolitinib 1.5% cream, is safe and effective to treat adults with prurigo nodularis. 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 60 weeks, including up to 4 weeks for screening, up to 52 weeks for treatment, and 30 days for safety follow-up. Eligible participants will be randomized 1:1 to receive ruxolitinib 1.5% cream or vehicle cream for the first 12 weeks. For the following 40 weeks all participants will receive the ruxolitinib cream.

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

A Phase 3, Multicenter, Double-blind Maintenance Study to Assess Long-term Safety, Tolerability, and Efficacy of Rocatinlimab in Adult and Adolescent Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-ASCEND)

Date Added
January 17th, 2024
PRO Number
Pro00131403
Researcher
Lara Wine Lee

List of Studies


Keywords
Children's Health, Skin
Summary

The study is being conducted in order to assess the long-term safety of rocatinlimab in adult and adolescent subjects with moderate-to-severe atopic dermatitis (AD). The study population will include subjects who completed an end of treatment duration visit in a parent study and meet eligibility criteria. Subjects will be randomized to receive a dosage of rocatinlimab based on age and their previous dosage from the parent study. The total duration of participation, including the parent study, will be up to 2.5 to 3 years, with a safety follow-up period after the last dose of investigational product at week 104.

Institution
MUSC
Recruitment Contact
Mikayla DiDonato
843-876-2281
didonato@musc.edu

A Phase 3, Multi-center, Open-label, Single-arm Study to Assess the Safety of Apremilast (AMG 407) in Pediatric Subjects from 6 Through 17 Years of Age With Mild to Moderate Plaque Psoriasis

Date Added
January 31st, 2024
PRO Number
Pro00130368
Researcher
Lara Wine Lee

List of Studies


Keywords
Children's Health, Skin
Summary

This study is being done to learn more about apremilast (AMG 407) in mild to moderate plaque psoriasis in participants (children and adolescents) aged 6 to 17 years. It will see whether it causes any side effects. About 50 people are expected to take part in this study. The duration of the study is approximately 285 days. This includes 3 phases: 35 days of screening phase, 225 days (32 weeks) of treatment phase, and 60 days of observational follow-up phase after the last dose of study drug – this means drug is still being tested to see if it is safe and works.

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

A Phase 3 randomized, placebo-controlled, double-blind program to evaluate efficacy and safety of upadacitinib in adult and adolescent subjects with severe alopecia areata

Date Added
February 7th, 2024
PRO Number
Pro00132680
Researcher
Lara Wine Lee

List of Studies


Keywords
Adolescents, Skin
Summary

The purpose of this study is to evaluate the efficacy and safety of upadicitinib in adults and adolescents with severe alopecia areata. Participation in this research study will take approximately 168 weeks with 17 visits in that time. This research study includes three phases; a screening phase, treatment phase, and a follow-up phase. The length of the screening period varies from 1 to 35 days, depending on therapies that must be washed out or discontinued before initiation of treatment. Patients who meet all eligibility criteria will be randomized to receive upadicitinib or placebo for the first 24 weeks. At week 24, all patients will receive upadicitinib until week 160. The post-treatment follow-up visit will occur approximately 30 days after the last study drug dose.

Institution
MUSC
Recruitment Contact
Devyn Spino
843-876-2281
spino@musc.edu

A Phase 2b, Double-Blind, Placebo-Controlled Study to Evaluate Eltrekibart in Adult Participants with Moderate to Severe Hidradenitis Suppurativa

Date Added
February 15th, 2024
PRO Number
Pro00132756
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

The purpose of this study is to evaluate the efficacy of eltrekibart compared to placebo in adults with moderate to severe HS. The study duration will be up to 67 weeks. This study includes a screening period, a 16-week double-blind, placebo-controlled treatment period, a 36-week double-blind maintenance treatment period, and a 10-week follow-up period.

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

A Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of MK-6194 in Adult Participants with Non Segmental Vitiligo

Date Added
February 20th, 2024
PRO Number
Pro00133486
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

The purpose of this research study is to study if the investigational drug, MK-6194, is safe and effective to treat adults with non-segmental vitiligo. In this study, MK-6194 or placebo administration will occur every two weeks or every four weeks to evaluate how well MK-6194 may treat non-segmental vitiligo. This study can last up to 60 weeks, including up to 4 weeks for screening, up to 52 weeks for treatment, and 14 days for safety follow-up. Eligible participants will be randomized 1:1:1 to receive MK-6194 every two weeks, every four weeks, or receive placebo.

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

A Double-Arm, Open Label, Phase III Study to Compare the Efficacy and Safety of SCENESSE® and Narrow-Band Ultraviolet B (NB-UVB) Light versus NB-UVB Light Alone in the Treatment of Vitiligo

Date Added
March 28th, 2024
PRO Number
Pro00135212
Researcher
Lara Wine Lee

List of Studies


Keywords
Adolescents, Skin
Summary

This is a double arm, open label, 20-week Phase III study with three and six-month follow up periods, in patients with a documented history of generalised vitiligo.
Up to 200 eligible patients across study sites will be enrolled and randomised in equal numbers to one of the following treatment groups:
• Group A will receive NB-UVB twice weekly from Day 0 (40 treatments in total), and SCENESSE® (one implant administered on Days 0, 21 (±4), 42 (±4), 63 (±4), 84 (±4), 105 (±4) and 126 (±4) (seven implants in total));
• Group B will receive NB-UVB light only (administered twice weekly for 20 weeks, 40 treatments in total).
To determine eligibility for study participation, patients will undergo a screening evaluation within a 28-day period before receiving the first study treatment.

Institution
MUSC
Recruitment Contact
Devyn Spino
843-876-2281
spino@musc.edu

A Prospective Observational Study of Patients Receiving Dupilumab for Prurigo Nodularis

Date Added
April 18th, 2024
PRO Number
Pro00129789
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

This is a non-interventional, prospective, multinational, post-marketing, observational study designed to describe the real-world effectiveness, safety, and patterns of use of dupilumab in patients with PN. This study will be conducted globally and will collect data available from patients' medical files and other items routinely collected during disease management in clinical practice and PROs related to disease, work productivity, and QoL.

Institution
MUSC
Recruitment Contact
Kennedy McLeod
843-792-4091
mcleodke@musc.edu



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