Epidermolysis Bullosa Clinical Characterization and Outcomes Database

Date Added
February 26th, 2026
PRO Number
Pro00142696
Researcher
Lara Wine Lee

List of Studies


Keywords
Pediatrics, Skin
Summary

Epidermolysis Bullosa (EB) is a rare, inherited skin condition that makes the skin extremely fragile, causing painful blisters and wounds from even minor friction or injury. There is currently no cure, and because EB is uncommon, doctors still have limited high-quality data to guide the best treatment and long-term care. This study is part of a large North American effort to collect and organize health information from people with EB into a secure database. By tracking how the disease progresses over time, along with symptoms, complications, and treatments, researchers hope to better understand EB and improve care for future patients. Participation involves consenting to share medical record information and optionally completing brief questionnaires during routine clinic visits or by email. No experimental treatments or extra medical procedures are involved. While there is no direct benefit to participants, the knowledge gained may help improve care and support the development of new treatments in the future.

Institution
MUSC
Recruitment Contact
Lara Wine Lee
843-792-2890
winelee@musc.edu

A LONG-TERM, DOUBLE-BLIND EXTENSION STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF RITLECITINIB IN PARTICIPANTS WITH SEVERE ALOPECIA AREATA WHO PREVIOUSLY COMPLETED STUDIES B7981027 OR B7981031

Date Added
February 18th, 2026
PRO Number
Pro00139005
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

Study B7981028 is a Phase 3 long-term, double-blind extension study aimed at evaluating the safety and efficacy of ritlecitinib in participants with severe alopecia areata (AA). This study includes individuals who have completed previous ritlecitinib studies, B7981031 or B7981027, and are eligible to enroll in the B7981028 study. The research seeks to gather more comprehensive data on the treatment's effects over an extended period.

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

A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Dose-Ranging Trial to Evaluate the Efficacy and Safety of Zasocitinib in Participants with Nonsegmental Vitiligo

Date Added
February 11th, 2026
PRO Number
Pro00146857
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

This phase 2, multicenter, randomized, placebo-controlled, double-blind, dose-ranging trial evaluates the efficacy and safety of zasocitinib in participants with nonsegmental vitiligo. The maximum trial duration for an individual participant is approximately 61 weeks (427 days), including a screening period of up to 35 days, a treatment period of up to 52 weeks, and a 4-week safety follow-up period. Participants will be randomly assigned to a blinded treatment with zasocitinib 15 mg QD, 30 mg QD, 75 mg QD, placebo/zasocitinib 30 mg, or placebo/zasocitinib 75 mg QD, via an IRT system.

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

A Randomized, Double-Blind, Vehicle-Controlled (Period 1) and Open-Label (Period 2)Phase 3 Study to Investigate the Safety and Efficacy of Tapinarof Cream, 1% in Pediatric Participants Ages 3 Months to < 24 Months with Atopic Dermatitis

Date Added
January 6th, 2026
PRO Number
Pro00148113
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

This Phase 3 study evaluates the safety and efficacy of tapinarof cream, 1%, for treating atopic dermatitis (AD) in pediatric participants aged 3 to under 24 months. Previous research, including two Phase 3 pivotal studies and a long-term study, assessed the cream in adults and children as young as 2 years. These studies showed minimal to no systemic exposure in children aged 2 to 17 with extensive AD. The findings support investigating the cream's safety and efficacy in younger participants, specifically infants and toddlers.

Institution
MUSC
Recruitment Contact
Andie Hoskins
843-792-6882
hoskinsa@musc.edu

A PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF RITLECITINIB IN PEDIATRIC PARTICIPANTS 6 TO LESS THAN 12 YEARS OF AGE WITH SEVERE ALOPECIA AREATA

Date Added
November 25th, 2025
PRO Number
Pro00147963
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

Ritlecitinib has been approved for treating severe alopecia areata (AA) in adults and adolescents aged 12 and older in the US, EU, and other countries, based on a positive benefit/risk assessment. However, there are no approved treatments for AA in children aged 6 to under 12. Study B7981027 is being conducted to evaluate the efficacy and safety of ritlecitinib in this younger group. This study is part of the EU Pediatric Investigation Plan (PIP) and fulfills a post-marketing requirement in the US.

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

A 16-WEEK, MULTICENTER, INTERVENTIONAL, PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF ABROCITINIB IN CHILDREN 6 TO LESS THAN 12 YEARS OF AGE WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS

Date Added
November 12th, 2025
PRO Number
Pro00144604
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

This is a randomized, double-blind, placebo-controlled study to assess the efficacy and safety of abrocitinib compared to a placebo in participants aged 6 to under 12 years with moderate-to-severe AD. Participants will be screened within 28 days before the first dose to confirm eligibility. Those who meet the criteria at baseline will be randomized 2:1 to receive either abrocitinib oral suspension (at a 100 mg adult equivalent dose once daily) or a matching placebo. Participants will be stratified by their baseline vIGA score (3 or 4). They will receive either abrocitinib or a matching placebo for 16 weeks. Additionally, participants must use emollients daily and follow standardized background medicated topical therapy (e.g., low to medium potency corticosteroids) according to protocol guidelines throughout the study's treatment period.

Institution
MUSC
Recruitment Contact
Andie Hoskins
843-792-6882
hoskinsa@musc.edu

Clinical Characteristics, Treatment Patterns and Outcomes in Patients with Alopecia Areata Following Initiation of Ritlecitinib, Baricitinib or Standard of Care Treatment.

Date Added
October 17th, 2025
PRO Number
Pro00146871
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

This study is a non-interventional, multicenter investigation of patient outcomes, combining a retrospective medical chart review with prospective patient questionnaires. It focuses on patients receiving ritlecitinib, baricitinib, or standard of care (SOC) treatment for alopecia areata (AA). Prospective data will be collected over 12 months following the start of treatment. The study aims to enroll 300 adults (aged 18 and older) and 100 adolescents/minors (aged 12-17) from 20-25 sites across the USA. Among the adult participants, 100 will receive ritlecitinib, 100 baricitinib, and 100 SOC. The adolescent/minor group will include 50 receiving ritlecitinib and 50 SOC.

Institution
MUSC
Recruitment Contact
Kenreka Yeadon
843-876-0110
yeadon@musc.edu

A PHASE 3, EXTERNAL AND SYNTHETIC PLACEBO‑CONTROLLED RANDOMIZED STUDY WITH DOSE-UP FOR NON-RESPONDERS TO INVESTIGATE SAFETY AND EFFICACY OF RITLECITINIB 50 MG AND 100 MG ONCE DAILY IN ADULT AND ADOLESCENT PARTICIPANTS 12 YEARS OF AGE AND OLDER WITH ALOPECIA AREATA

Date Added
September 12th, 2025
PRO Number
Pro00143084
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

This research study aims to evaluate how effective and safe the 100 mg daily dose of ritlecitinib is for participants. By including the already approved 50 mg daily dose as a reference point, the study seeks to draw direct comparisons between these two dosages. This comparison will help determine if increasing the dosage offers additional benefits or poses any new risks. Participants in this study will be closely monitored to assess both their response to treatment and any potential side effects that may arise. The findings from this investigation are expected to provide valuable insights into optimizing ritlecitinib dosing regimens for better therapeutic outcomes.

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

The Impact of Skin Disease on Self-Reported Quality of Life and Psychosocial Health in Youth with Cutaneous Lupus Erythematosus

Date Added
September 9th, 2025
PRO Number
Pro00142882
Researcher
Lara Wine Lee

List of Studies


Keywords
Children's Health, Lupus, Pediatrics, Skin
Summary

Cutaneous lupus is a common manifestation of childhood-onset Systemic Lupus Erythematosus (cSLE), affecting up to 85% of patients. Skin involvement can cause irritation, scarring, hair loss, changes in skin color and appearance, which may negatively impact quality of life and mental health. This study aims to assess the impact of cutaneous lupus on quality of life and mental health in diverse pediatric populations, with the goal of identifying disparities and improving individualized care. We will use validated surveys to assess disease burden on quality of life.

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

A Phase 3, Double-Blind, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa: Topical Ruxolitinib Evaluation in Hidradenitis Suppurativa (TRuE-HS1)

Date Added
August 21st, 2025
PRO Number
Pro00144283
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

The primary purpose of this study is to assess the efficacy and safety of ruxolitinib 1.5% cream applied twice daily in participants with mild to moderate HS (Hurley Stage I or II) without draining tunnels.

Institution
MUSC
Recruitment Contact
Kennedy McLeod
8437924091
mcleodke@musc.edu



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