Randomised, double-blind, placebo-controlled, Phase IIb/Phase III study to evaluate the efficacy and safety of spesolimab in patients with moderate to severe hidradenitis suppurativa. Lunsayil 1.

Date Added
August 17th, 2023
PRO Number
Pro00129550
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

This is an international, Phase IIb/III multi-center, double-blind, placebo-controlled, randomised trial assessing the efficacy and safety of spesolimab versus placebo in patients with moderate to severe HS. Approximately 200 trial participants in Part 1 (Phase IIb) and 260 trial participants in Part 2 (Phase III) will be randomised. For Part 1, after signing the informed consent, trial participants will enter the screening period for up to 28 days, and if all eligibility criteria are met, trial participants will be randomised in a 1:1:1:1 ratio to either active group, including high dose, medium dose, and low dose group, or placebo group. Once randomised, trial participants will start a treatment period of 50 weeks. Administration of treatment will be up to Week 48.

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

Comparing compression wrap to compression plus longitudinal elastic netting in leg wounds.

Date Added
August 15th, 2023
PRO Number
Pro00129952
Researcher
Joshua Visserman

List of Studies

Keywords
Skin
Summary

This study's purpose is to research the effect that a compression bandage application has on the skin when applied over an area that has a wound. To better understand the healing process, special cameras and other devices will be used to measure the change in the wound and limb size, temperature of the skin around the wound, amount of oxygen in the tissue around the wound, and the amount of water in the skin before and after a compression bandage is applied. This research will involve two different compression bandage applications, both of which are standard of care.

Institution
MUSC
Recruitment Contact
Travita Lee
(843) 792-2927
leetrav@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, 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

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

Utility and Histologic Effects of the J-Tip Device in Dermatologic Conditions Requiring Local Anesthesia

Date Added
May 2nd, 2023
PRO Number
Pro00107787
Researcher
Lara Wine Lee

List of Studies


Keywords
Cancer/Skin, Skin
Summary

This project is a pilot study to determine if use of the J-Tip Needle-Free Injection System, used to administer local anesthesia, has any effects on the appearance of skin samples when viewed under a microscope compared with skin samples that have been injected with local anesthesia using a needle. If use of the J-Tip device for local anesthesia delivery is shown not to alter the microscopic appearance of skin, anesthesia for skin biopsies in the future may potentially be performed without a needle, allowing for less fear and pain.

Institution
MUSC
Recruitment Contact
Lara Wine Lee
(843) 792-3021
winelee@musc.edu

A Phase 3, Randomized, 52-week, Placebo-controlled, Double-blind Study With Rerandomization to Assess the Efficacy, Safety, and Tolerability of Rocatinlimab (AMG 451) in Adolescent Subjects With Moderate-to-severe Atopic Dermatitis (AD)

Date Added
April 12th, 2023
PRO Number
Pro00127271
Researcher
Lara Wine Lee

List of Studies


Keywords
Children's Health, Skin
Summary

The study is being conducted to learn more about rocatinlimab in people with AD. It will see if rocatinlimab is effective to treat people with AD and whether it causes side effects. It will also help to establish the beneficial impact of the study treatment with rocatinlimab on the related outcomes including skin itching, skin pain, sleep loss, and impaired quality of life in people with AD. The study duration will last a maximum of 68 weeks (about 1 year 3 months), including a screening period of minimum of 8 days and up to 30 days, a 52-week study treatment period, and a safety follow-up (SFU) visit 16 weeks after the last dose of study drug in case you do not continue into the long-term maintenance study.

Institution
MUSC
Recruitment Contact
Madeline Richmond
843-792-1436
richmoma@musc.edu

A Phase 3 Multicenter, Single-Arm, Open-Label Study Evaluating the Safety, Tolerability and Efficacy of StrataGraft® Construct in Pediatric Subjects with Deep Partial Thickness (DPT) Thermal Burns

Date Added
April 10th, 2023
PRO Number
Pro00125082
Researcher
Steven Kahn

List of Studies


Keywords
Skin, Surgery
Summary

To evaluate whether StrataGraft treatment promotes wound closure and reduces or
eliminates the need for donor site harvest and autografting in a pediatric population with thermal burns that contain intact dermal elements and for which autografting would be part of standard of care (deep partial-thickness [DPT] burns). Study assessments will include the incidence of adverse events (AEs), including wound
infection, and additionally monitoring of vital signs, clinical laboratory values, immunological values (where possible), wound closure, including any autografting, and skin quality of the treatment site.

Institution
MUSC
Recruitment Contact
Courtney Tresslar
843-792-0325
tresslar@musc.edu

Impact of Systemic Tetracyclines in Adolescence on Metabolism, Adiposity, and Skeletal Maturation

Date Added
April 4th, 2023
PRO Number
Pro00120674
Researcher
Lara Wine Lee

List of Studies


Keywords
Adolescents, Skin
Summary

In clinical practice, standard of care for treatment of adolescent acne includes extended courses, i.e., 3 months or longer, of systemic tetracyclines, a type of antibiotic.The gut is home to many bacteria. Administration of antibiotics kills these bacteria and prevents them from repopulating during critical developmental periods. The lack of these bacteria has effects on metabolism, fat, and bone mass
accrual in adolescent mice. Given what we have observed in mouse studies,
we are interested to observe the impact of systemic tetracycline acne therapy in adolescents on fat deposition and the skeleton.

Institution
MUSC
Recruitment Contact
Courtney Linkous
8435662453
linkousc@musc.edu

A Phase 3b/4 Randomized, Open-label, Efficacy Assessor Blinded Study, Comparing the Safety and Assessor Blinded Efficacy of Upadacitinib to Dupilumab in Subjects with Moderate to Severe Atopic Dermatitis (Level-Up)

Date Added
March 22nd, 2023
PRO Number
Pro00125074
Researcher
Lara Wine Lee

List of Studies


Keywords
Children's Health, Pediatrics, Skin
Summary

This is a global, Phase 3b/4, randomized, open-label, efficacy assessor-blinded, multi-center study that will evaluate upadacitinib compared with dupilumab, as monotherapy, in adolescents and adult subjects who have inadequate response to systemic therapy. The study will consist of a 35-day Screening Period; Period 1, a 16-week randomized, open-label, efficacy assessor blinded treatment period for all subjects, and a 30-day or 12-week follow-up visit for subjects on upadacitinib and dupilumab respectively, who will not enter the Period 2; Period 2, a 16-week open-label, efficacy assessor blinded extension period for those subjects with a < EASI 75 response at Week 16 (total duration 32 weeks) and a 30-day follow-up visit.

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



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