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Longitudinal Characterization of Pediatric-Onset Morphea
This study aims to better understand the natural history and clinical features of morphea. A retrospective review of our institutional experience with this disease is combined with a prospective registry. Standardized assessments will be completed at each visit. A tissue bank consisting of blood and skin samples will be accumulated over time to allow for translational research projects in the future.
Vascular Malformations and Abnormalities of Growth
The primary goal of this pilot study is to identify potential biomarkers for patients with vascular malformations and variable clinical phenotypes that are potentially be tested in larger clinical trials. Patients with vascular malformations will be evaluated for global or mosaic growth abnormalities in an effort to assess the extent of these associations. Patients will be clinically evaluated for growth abnormalities and will have systematic molecular studies performed to detect abnormalities in the P13 kinase/AKT signaling pathway.
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
Principal Investigator: Kristen Holland, MD
Enrolling age: 6 months to less than 6 years
The purpose of this study is to test the effectiveness and safety of a potential new drug called lebrikizumab in children with moderate to severe atopic dermatitis, and to see how well the study drug works when used with topical medication.
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
Principal Investigator: Kristen Holland, MD
Enrolling age: 6 months to less than 6 years
The purpose of this study is to better characterize atopic dermatitis and document the real-world effectiveness and safety of treatments.
A Phase 3, Open-label, Efficacy-Assessor-Blinded Study, Comparing the Safety and Efficacy of Upadacitinib to Dupilumab in Children from 2 to Less than 12 Years of Age with Moderate to Severe Atopic Dermatitis (START UP)
Principal Investigator: Kristen Holland, MD
Enrollment age: 2 years to less than 12 years
The purpose of this study is to assess the efficacy and safety of upadacitinib, compared with dupilumab at the label-indicated dose and frequency, in pediatric subjects 2 to < 12 years of age with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.
A Phase 3, randomized, double-blind, placebo-controlled, parallel-group, 3-arm, multinational, multicenter study to evaluate the efficacy and safety of amlitelimab by subcutaneous injection in participants aged 12 years and older with moderate-to-severe atopic dermatitis (AD) who are on background topical corticosteroids and have had an inadequate response to prior biologic therapy or oral Janus Kinase (JAK) inhibitor treatment
Principal Investigator: Kristen Holland, MD
Enrollment age: 12 years and older
The purpose of the study is to evaluate a new investigational drug, amlitelimab, for the treatment of moderate-to-severe AD in children and adults who have either failed or been intolerant of treatment with either biologic therapy or oral Janus Kinase (JAK) inhibitor treatment.
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Deucravacitinib (BMS-986165) in Adolescent Participants (12 years to less than 18 years) with Moderate to Severe Plaque Psoriasis
Principal Investigator: Kristen Holland, MD
Enrollment age: 12 years to less than 18 years
The purpose of this study is to evaluate the efficacy and safety of deucravacitinib, a medication currently approved for 18yo and older, in children between the ages of 12 years to less than 18 years with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
Clinical, Immunologic, and Genetic Characterization of Severe Mucocutaneous Reactions
Principal Investigator: Yvonne Chiu, MD
The goal of this multicenter study is to develop a better understanding of the cause of reactive infectious mucocutaneous eruption (RIME) and other severe blistering skin reactions. We hope that by better understanding the cause we may be able to improve care for people who are affected by these skin reactions. For more information and to express interest in participating, please visit the study website.
Development of the Morphea Activity and Damage Measure (MADM)
Principal Investigator: Yvonne Chiu, MD
Dr. Chiu is leading a team of international morphea experts to develop and validate the a new cutaneous outcome measure for morphea called the Morphea Activity and Damage Measure (MADM). The development of MADM is crucial, as the lack of effective outcome measures hampers patient care and future research efforts in morphea treatment. The ultimate goal is to identify safer and more effective therapeutic interventions for morphea, with MADM serving as a vital step towards achieving this objective.
Pediatric Dermatology Curriculum
Principal Investigator: Leah Lalor, MD
Dr. Lalor is interested in educational research. She is developing a lecture series on basic pediatric dermatology for pediatric residents.
Acne Management
Principal Investigator: Leah Lalor, MD
Series of projects regarding safe and effective treatment of acne in adolescents.
