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Clinical Trials: Skin
IRB No. 03-007-1 (Dr. Ernst Reichenberger, PI): Genetic Analysis of Human Disorders: Keloid Formation
The purpose of this study is to identify genes which cause or contribute to keloid formation. Keloids are wounds which grow beyond the margin of the original skin wound.
IRB No. 19-036-1 (Dr. Jun Lu, PI): Rheumatology-Dermatology Combined Clinic Patient Registry
The Rheumatology-Dermatology Combined Clinic Patient Registry is a prospective registry that collects patient data within the UConn Department of Dermatology combined clinic for patients being treated for both rheumatologic and dermatologic conditions. Both dermatologists and rheumatologists participate in care for patients suffering from connective tissue disease with both cutaneous and rheumatological manifestations. By establishing combined rheumatology-dermatology clinic, patients will receive collaborative care from both specialties in the same visit. The combined multidisciplinary clinic offers the opportunity for improving care quality, patient satisfaction, and continued education and professional development for physicians. The protocol includes patients over the age of 18 that are being treated in the UConn combined rheumatology-dermatology clinic. This registry will gather data over a 10 year period for future research regarding improving patient care, diagnosis, treatment and long term outcomes for this subspecialty clinic.
IRB No. 21-074-2 (Dr. Jun Lu, PI): Corrona Atopic Dermatitis Registry: A Study of Post Approval Drug Safety and Effectiveness
The objective of the Corrona Atopic Dermatitis (AD) Registry is to create a national cohort of patients with atopic dermatitis. Data collected will be used to extensively evaluate the effectiveness and safety of medications used to treat atopic dermatitis. This will be done through the standardized collection of patient-reported outcomes (PRO) and clinician-reported outcomes (ClinRO), and the prevalence and incidence of comorbidities and adverse events, medication utilization patterns, and patient productivity measures.Personal information is also collected from each consenting registry patient allowing for linkages to other public or private clinical and administrative databases, as well as to databases maintained by organizations focused on the care and treatment of atopic dermatitis for the purposes of clinical, market, or outcomes research. This provides an opportunity to evaluate other aspects of the disease and its treatment including but not limited to clinical and drug cost-effectiveness, healthcare resource utilization, and patient adherence.
IRB No. 21-095J-2 (Dr. George Kuchel, PI): Dynamic assessment of immune system in COVID-19 patients Pilot Study 2: Aging and the Cutaneous Immune System in Young and Older Adults
This prospective, single-site pilot study is designed to determine the feasibility to recruit and enroll COVID-19 convalescent adults into a study that will assess immunity changes associated with aging. To complete a 8-subject pilot study with the following aims: To establish feasibility of conducting a larger trial with the enrollment of adults that have recovered from COVID-19 and healthy adults, we will enroll 4 younger adults (25-50 years) and 4 older adults (>65 years) and collect skin samples using punch biopsy and blood samples. To enumerate and assess functional status of dendritic cells, monocytes, macrophages, T cells and B cells in skin biopsies using multi-marker immunofluorescence and histo-cytometry (10+ markers) as well as image mass spectrometry (IMC) (30+ marker analysis in intact tissues). This is a prospective, single-site pilot study that will use an established and comprehensive approach to cellular and molecular analysis of non-dissociated tissues that will be applied herein to assess tissue immunity and changes associated with COVID-19 and aging. In this study, a total of 8 healthy adult participants who have either recovered from COVID-19 or have had no history of confirmed COVID-19 will be enrolled: four (4) older adults aged 65 years and older and four (4) younger adults aged 25-50 years. Participation in the study will involve two study visits scheduled on two consecutive days and up to three follow-ups via phone or email over three weeks after the biopsies. Subjects will be administered an intradermal injection of saline on one arm and two punch skin biopsies will be performed at the site of injection and adjacent the next day under local anesthesia. The biopsy sites will be closed with an absorbable suture. Peripheral blood specimens (50 mL each) will be collected at both study visits. Self-reported medical history, medication history and demographics information will be collected at Visit 1.
IRB No. 23-173-1 (Dr. Roshanak Sharafieh, PI): Biomarker Development to Promote Geroscience-Guided Approaches to Chronic Wound Management in Older Adults
This research is being done to help better understand the role that senescent cells play in human wound healing in older adults. The goals of this pilot project are to provide: 1) junior faculty interested in human subjects research involving older adults with experience in the preparation of an IRB protocol, recruitment of human subjects and frailty assessments 2) provide investigators interested in translational aging research with the opportunity to generate early stage feasibility and preliminary human data that could then be used in future NIH grant applications. This will be accomplished using a cohort of older adults who have a lower extremity wound and studying their healing of the wound tissue compared to that of the healthy tissue over time. In order to achieve the objective, we propose the following aims: In Aim 1, Dr. Sharafieh and her research team will recruit individuals who have developed new early-stage lower extremity wounds within 1-3 weeks of presentation. Baseline research assessments will be completed and working with Drs Alam, Santiago, and/or Kerr, a tissue biopsy will be obtained to look for cellular senescence markers. In Aim 2, all individuals recruited during initial wound presentation (Aim 1) will be followed 5-7 weeks later and again 8-12 weeks after the onset of the wound to repeat clinical wound assessment, repeat wound biopsy. The purpose of this is to identify and quantify similarities and differences in wound biopsies throughout their healing process. The results from this follow up will show what markers are associated with senescence in the wounds when compared to individuals with properly healing wounds.
IRB No. 24-158J-2 (Dr. Julie Robison, PI): Skin immunity as a function of frailty, aging, and skin microbiome composition
Specific Aims AIM 1. Identify distinct and common skin immune features associated with aging and frailty-associated dysbiosis (FADS) to inform skin infection risk. AIM 2. Model how aging-related changes in skin infection response are modulated by the microbiome, senescence, inflammation, and genetic diversity. Design and Outcomes This is a prospective, observational, cohort study that will investigate how age-related declines in skin immunity relate to corresponding changes in the skin and its microbiome. Sample Size, Population, Interventions and Duration In this study, 42 participants ages 20-40 years old and 82 participants ages 60 years and older will be enrolled at the UConn Center on Aging in Farmington, CT and will participate in 4 study visits over 5 weeks. Visit 2 will occur the day after Visit 1. Visit 3 will occur 21 +/- 7 days after Visit 1 and Visit 4 the day after Visit 3. Skin (swab and microneedle patch at 7 skin sites) will be collected from participants to study the microbiome, immune profiling of interstitial fluid (ISF), and metabolomics. The seven skin sites will also be probed for skin physiologic metrics associated with frailty and aging. Participants will also have the option to provide oral swabs and self-collected stool samples that will be banked for future studies. The study is not designed to assess safety or tolerability of microneedle patch used as part of this proposed study.