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 Phase 3a, observer-blind, randomized, controlled study to demonstrate lot-to-lot consistency and evaluate the immunogenicity and safety of an investigational varicella vaccine compared with Varivax, administered as a first dose to healthy children 12 to 15 months of age

Date Added
February 10th, 2026
PRO Number
Pro00145276
Researcher
Robert Clifford

List of Studies


Keywords
Adolescents, Children's Health, Pediatrics, Vaccine
Summary

The investigational varicella vaccine (hereafter referred to as VNS vaccine) is a new
candidate varicella vaccine derived from the Oka strain. The main rationale for the
development of VNS vaccine is to provide an additional alternative varicella vaccine as an advantage from a public health perspective to prevent varicella disease

Institution
MUSC
Recruitment Contact
Amelia Gaines
843-284-4254
gaineame@musc.edu

A Pragmatic Clinical Trial of the WE BEAT Well-Being Education Program in Adolescent Congenital Heart Disease: WE BEAT CHD Study

Date Added
January 21st, 2026
PRO Number
Pro00148198
Researcher
Stephanie Gaydos

List of Studies

Keywords
Pediatrics
Summary

The overall goal of this study is to learn how to best support teens with CHD to improve their health and quality of life. Adolescents with moderately and severely complex CHD experience considerable risk of mental health comorbidities. Psychological health is important to cardiovascular health and related outcomes. This study will evaluate the effectiveness of a well-being focused telemedicine intervention in adolescents with CHD. The study is to learn if the WE BEAT program helps teens with CHD improve their ability to cope with stress and anxiety. The study will also create a data bank to study connections between mental health, heart health and biomarkers (hair, saliva, urine, blood samples).

Institution
MUSC
Recruitment Contact
Terry Headley
843-494-3796
headleyt@musc.edu

A PHASE 2, RANDOMIZED, PARTIALLY DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE ADMINISTERED IN HEALTHY TODDLERS 12 THROUGH 15 MONTHS OF AGE

Date Added
September 16th, 2025
PRO Number
Pro00146400
Researcher
Stephen Stripling

List of Studies

Keywords
Children's Health, Healthy Volunteer Studies, Pediatrics, Vaccine
Summary

This is a Phase 2, multicenter, randomized, partially double-blind study to evaluate the safety, tolerability, and immunogenicity of PG4 in healthy toddlers 12 through 15 months of age who previously received 3 infant doses of 20vPnC. This study will be conducted at investigator sites in the US and Puerto Rico. Approximately 225 children between 12 and 15 months of age will be enrolled and randomized in a 2:2:1 ratio by site-based randomization to receive either 1 or 2 doses of PG4 (90 participants per group) or 1 dose of the control vaccine 20vPnC (45 participants). The vaccine in toddlers randomized to receive 1 dose will be double-blind, as PG4 and 20vPnC have the same appearance and a single dose will be administered at Visit 101 of the study. For participants randomized to 2 doses of PG4, the parents/legal guardians and site staff will know that these participants will need to return for a second vaccination visit and that they will receive PG4 at both Visit 201 and Visit 202.

Institution
MUSC
Recruitment Contact
Meghan Armistead
8434736623
mea301@musc.edu

A Randomized Trial of Dichoptic Treatment for Amblyopia in Children 4 to 7 Years of Age

Date Added
September 16th, 2025
PRO Number
Pro00141315
Researcher
James Bowsher

List of Studies

Keywords
Children's Health, Pediatrics, Vision/ Eye
Summary

Children with amblyopia (lazy eye) are often treated with patch therapy. Patch therapy often results in leftover amblyopia and has many challenges associated with its use. This study will determine how traditional patch therapy results compare to those achieved with the Luminopia digital therapeutic system.

Institution
MUSC
Recruitment Contact
Martha Long
843-792-6591
mas405@musc.edu

A Randomized Trial of Dichoptic Treatment for Amblyopia in Children 8 to 12 Years of Age

Date Added
September 12th, 2025
PRO Number
Pro00142574
Researcher
James Bowsher

List of Studies

Keywords
Children's Health, Pediatrics, Vision/ Eye
Summary

Children with amblyopia (lazy eye) are often treated with patch therapy. Patch therapy often results in leftover amblyopia and has many challenges associated with its use. This study will determine how traditional patch therapy results compare to those achieved with the Luminopia digital therapeutic system.

Institution
MUSC
Recruitment Contact
Martha Long
8437926591
mas405@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

Integrating corticospinal tract assessment via sTMS and taVNS-augmented CIMT in infants with hemiplegia

Date Added
September 2nd, 2025
PRO Number
Pro00146198
Researcher
Dorothea Jenkins

List of Studies


Keywords
Brain, Central Nervous System, Infant, Pediatrics, Physical Therapy, Rehabilitation Studies, Stroke Recovery
Summary

Newborns who are born premature or infants who suffer brain injury are at risk for motor problems. The common motor skills of reaching and grasping that infants have to learn can be weaker on one side of the body, depending on the site of the brain injury. These skills are routinely practiced with an occupational therapist once or twice a week, to help the infant strengthen these skills. A high intensity therapy program of constraint induced movement therapy (CIMT) may be available for the infant, but it takes from 40-120 hours total treatment time for most infants to improve their motor skills.
Transcutaneous auricular vagus nerve stimulation (taVNS) stimulates a branch of a major nerve by the ear, called the vagus nerve, that may help improve your child's ability to learn motor skills. CIMT involves placing a soft mitt constraint on the stronger arm and hand while encouraging your child to use the weaker arm and hand during intensive therapy sessions. By using both CIMT and the nerve stimulation together, we hope your child's movement skills will improve more than with therapy alone.
The purpose of this study is to evaluate the safety and effectiveness of taVNS to improve motor skills when paired with the minimal amount of CIMT and whether a measure of the strength of the brain circuit to the arm and hand muscles can tell us how well a child may respond to this therapy.

Institution
MUSC
Recruitment Contact
Dorothea Jenkins
843-792-2112
jenkd@musc.edu

Fostering Healthy Relationships through Tele-PCIT for Families of South Carolina

Date Added
August 24th, 2025
PRO Number
Pro00146035
Researcher
Rosmary Ros-Demarize

List of Studies


Keywords
Children's Health, Pediatrics
Summary

The purpose of this research study is to evaluate Parent Child Interaction Therapy (PCIT) delivered via tele-health for young children with disruptive behavior problems who are at risk for life stressors. Participants will go through a screening to determine eligibility. Once screening is complete, eligible families who choose to participate will complete questionnaires, 3 virtual visits, and will receive 10 tele-health therapy sessions, at no cost. Families will be compensated for their time.

El propósito de este estudio de investigación es evaluar la Terapia de la Interacción Padre-Hijo (PCIT, por sus siglas en inglés) mediante telesalud para niños pequeños con dificultades de comportamiento que están en riesgo de factores de estrés en la vida. Los participantes pasarán un cernimiento para determinar su elegibilidad. Una vez que se complete, las familias elegibles que decidan participar completarán cuestionarios, 3 visitas virtuales y recibirán 10 sesiones de terapia por telesalud, que serán gratuitas. Las familias recibirán compensación por su tiempo.

Institution
MUSC
Recruitment Contact
Franchesca Araya
843-714-1352
pcitfamilias@musc.edu

A PHASE 2, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY INFANTS

Date Added
August 21st, 2025
PRO Number
Pro00146402
Researcher
Stephen Stripling

List of Studies

Keywords
Children's Health, Healthy Volunteer Studies, Pediatrics, Vaccine
Summary

This will be a Phase 2, multicenter, randomized, double-blind study conducted at
investigator sites in the US and Puerto Rico. Each participant will participate in the study for approximately 16 to 19 months. The purpose of the study is to evaluate the safety, tolerability, and immunogenicity of PG4 in both the M1 and M2 formulations, in healthy infants when administered at 2, 4, 6, and 12 through 15 months of age. Safety, tolerability, and immunogenicity data will support further development of PG4 in the pediatric population.

Institution
MUSC
Recruitment Contact
Meghan Armistead
8434736623
mea301@musc.edu



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