Research
Clinical Research Unit
Research Emphasis
Basic and clinical research interests include the pathogenesis and treatment of inflammatory dermatoses, cutaneous lymphomas, oncodermatology, and inpatient dermatology.
The USF Health Division of Dermatology and Cutaneous Surgery, Clinical Research Unit utilizes the USF Health Morsani Clinical Research Center where pharmaceutical industry sponsored, divisional clinical research projects and federal and non-federal grant funded clinical research projects are conducted.
The Clinical Research Center (CRC) is located on the fourth floor of the Morsani building. The CRC was designed to provide an infrastructure to assist investigators in the implementation and conduct of clinical research. A key attribute of the CRC is that it provides patients and their families with a variety of amenities to encourage retention in clinical research projects. These features include convenient free garage parking adjacent to the clinic building, friendly concierge service upon arrival, private exam rooms for study visits and free guest wireless internet access.
The CRC features the following facility, equipment and services to aid investigators and research personnel across various disciplines:
- On-site Nurse Manager
- Four clinical examination rooms equipped with exam table, otoscope, ophthalmoscope, vital signs equipment, computer, telephone, and sink
- Three phlebotomy/ ECG rooms that can also be utilized for infusions
- Basic specimen processing area equipped with refrigerated centrifuge
- Ambient, cold, and frozen secure storage for investigational product or short term specimen storage, monitored and recorded per SOP, that includes two 2-8° C refrigerators, a -20° C freezer, and a -80° C freezer all locked and on red electrical outlets
- Large Chest for central dry ice supply
- Automated vital signs monitor, AED, limited anthropometric equipment, secure document disposal, printer/fax/copier/scanner, analog line for data transmission
- Calibration and service record maintenance for all CRC equipment
- CRC Standard Operating Procedures (SOP) Manual
- Scheduling of facility is done on a Resource level in EPIC
- Conveniently located a short walk or drive from the Byrd Alzheimer’s Disease Research Institute PET scanning facility
All studies performed are done under the supervision of the physicians and the staff and approved by the University’s Human Research Committee. Over the past several decades, the Clinical Research faculty have conducted Phase I, II, III and IV clinical trials and established a working relationship with more than 40 pharmaceutical sponsors, NIH, ALA, VA and many other funding sources. Staffed by USF clinicians, the Division and the Clinical Research Center are affiliated with various institutions in the Tampa Bay Area including the H. Lee Moffitt Cancer Center, James A. Haley Veterans’ Hospital, Tampa General Hospital, Florida Hospital and All Children’s Hospital.
Research Capabilities
- Exceeding enrollment requirements is our commitment to quality research.
- Research is conducted in accordance with Good Clinical Practice Guidelines and the highest ethical standards are followed.
- Experienced clinical research coordinators.
- Full-time regulatory coordinator which facilitates timely start-up of new clinical trials.
- Contracted with Western IRB, Advarra and others for multi-center trials.
Meeting enrollment requirements is standard practice.
Population: Tampa Bay metropolitan area
- 2.5 million population
- Varied ethnic composition
- Easily reached with appropriate media exposure
Clinical Trial Contact Information
For more information about clinical trials, please contact:
Lucy Lam, RN
Sr. Clinical Research Associate, Department of Dermatology and Cutaneous Surgery
llam@usf.edu
(813) 493-3034
Atopic Dermatitis
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Pending Enrollment
The purpose of this study is to confirm the efficacy and safety of rocatinlimab monotherapy in adult subjects presenting with moderate-to-severe atopic dermatitis whose disease cannot be adequately controlled with topical medications or for whom topical medications cannot be prescribed medically because of intolerance or safety risks.
For more information, please visit https://clinicaltrials.gov/ct2/show/NCT05398445
To enroll in this study at USF, please contact USF Dermatology Research at (813) 493-3034.
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Pending Enrollment
The purpose of this study is to confirm the efficacy and safety of 2 doses of rocatinlimab in both monotherapy and in combination with topical corticosteroid/topical calcineurin inhibitor in adolescent subjects presenting with moderate-to-severe AD with inadequate response to topical medications.
For more information, please visit https://clinicaltrials.gov/ct2/show/NCT05704738
To enroll in this study at USF, please contact USF Dermatology Research at (813) 493-3034.
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Currently Enrolling
The purpose of this study is to assess the safety, tolerability, PK, efficacy, and PD of multiple doses of IMG-007 in participants with atopic dermatitis. Participants will receive three in fusions over four weeks.
For more information, please visit https://clinicaltrials.gov/ct2/show/NCT05984784
To enroll in this study at USF, please contact USF Dermatology Research at (813) 493-3034.
Dermatomyositis
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Currently Enrolling
The purpose of this study is to determine the efficacy and safety of brepocitinib (a TYK2/JAK1 inhibitor) in patients with dermatomyositis.
For more information, please visit https://clinicaltrials.gov/ct2/show/NCT05437263
To enroll in this study at USF, please contact USF Dermatology Research at (813) 493-3034.
Plaque Psoriasis
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Pending Enrollment
The purpose of this study is to evaluate the safety of apremilast in children with mild-to-moderate plaque psoriasis. This is an open-label study, meaning there will not be any placebo given, because apremilast has been studied and proven effective in pediatric patients ages 6-17 years old. This study is to confirm the long-term safety in this same pediatric population.
To enroll in this study at USF, please contact USF Dermatology Research at (813) 493-3034.
Non-segmental Vitiligo
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Pending Enrollment
The purpose of this study is to determine the efficacy, safety, and tolerability of oral ritlecitinib in adult participants with non-segmental vitiligo through a phase 3, randomized, double-blind, 52 week placebo-controlled study with randomized dose-up/down titration.
For more information about this study, please visit https://classic.clinicaltrials.gov/ct2/show/NCT05583526
To enroll in this study at USF, please contact USF Dermatology Research at (813) 493-3034.