Dermatology & Cutaneous Surgery

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Research

Overview

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, MSMS, CCRC
Clinical Research Nurse
llam@usf.edu 
(813) 493-3034

CTCL

  • Currently Enrolling.

    The purpose of this study is to evaluate the use of HyBryte, a topical photosensitizing agent, to treat patients with patch/plaque phase cutaneous T-cell lymphoma (mycosis fungoides).

    Study medication: topical Hypericin + light treatment

    Requirements: ≥18 years old with a diagnosis of mycosis fungoides Stage IA, IB, or IIA. Must have at least 3 CTCL lesions.

    For more information, please visit https://clinicaltrials.gov/study/NCT06470451.

    To enroll in this study at USF, please contact USF Dermatology Research at (813) 493-3034.

Hidradenitis Suppurativa

  • Currently Enrolling.

    The purpose of this study is to assess efficacy, safety and tolerability of remibrutinib in adult patients with moderate to severe hidradenitis suppurativa (HS).

    Study medication: Remibrutinib (oral pill)

    Requirements: ≥18 years old, Hurley stage II or III, and have ≥5 HS lesions. Cannot have Hemoglobin < 10 g/dL, significant bleeding risk/coagulation disorders, or be on dual antiplatelet therapy.

    For more information, please visit https://clinicaltrials.gov/study/NCT06799000.

    To enroll in this study at USF, please contact USF Dermatology Research at (813) 493-3034.

  • Currently Enrolling.

    The purpose of this study is to evaluate the efficacy and safety of Lutikizumab in adult and adolescent subjects with moderate to severe hidradenitis suppurativa.

    Study medication: Lutikizumab (subcutaneous injection)

    Requirements: ≥18 years old, Hurley stage II or III, and have ≥5 HS lesions.

    For more information, please visit https://clinicaltrials.gov/study/NCT06468228?rank=1.

    To enroll in this study at USF, please contact USF Dermatology Research at (813) 493-3034.

  • Currently Enrolling.

    The purpose of this study is to evaluate the efficacy and safety of ruxolitinib cream in participants with hidradenitis suppurativa.

    Study medication: Ruxolitinib (topical cream)

    Requirements: ≥12 years old, diagnosis of HS for 6 months, Hurley stage I or II, and have ≥4 HS lesions. Cannot have ANY draining fistulae.

    For more information, please visit https://clinicaltrials.gov/study/NCT06958211.

    To enroll in this study at USF, please contact USF Dermatology Research at (813) 493-3034. 

  • Currently Enrolling. 

    The purpose of this study is to learn about the safety and effects of the study medicine (called Ritlecitinib) for the possible treatment of hidradenitis suppurativa (HS). HS is a disease causing long lasting painful red skin lumps.

    Study medication: Ritlecitinib (oral pill)

    Requirements: ≥18 to ≤75 years of age, Hurley stage II or III, and have ≥ 5 HS lesions. Cannot have prior exposure to any JAK or BTK inhibitor.

    For more information, please visit https://clinicaltrials.gov/study/NCT07228390.

    To enroll in this study at USF, please contact USF Dermatology Research at (813) 493-3034. 

Nonsegmental Vitiligo (Pediatrics)

  • Currently Enrolling.

    The purpose of this study is to to evaluate the safety and efficacy of ruxolitinib cream in pediatric participants with nonsegmental vitiligo.

    Study medication: Ruxolitinib (topical cream)

    Requirements: 2 to 11 years old, Must have ≥0.5% BSA on the face and ≥3% BSA on non-facial areas. Cannot have ever used JAK inhibitors.

    For more information, please visit https://clinicaltrials.gov/study/NCT06548360.

    To enroll in this study at USF, please contact USF Dermatology Research at (813) 493-3034.

Palmoplantar Pustulosis (opening soon)

  • Enrolling Soon.

    The purpose of this study is to evaluate the efficacy and safety of bimekizumab compared with placebo in participants with palmoplantar pustulosis (PPP).

    Study medication: Bimekizumab (subcutaneous injection)

    Requirements: ≥18 years old with a diagnosis of palmoplantar pustulosis for at least 24 weeks. Must have pustules on palms and/or soles and have ≥5 active white-yellow pustules. 

    For more information, please visit https://clinicaltrials.gov/study/NCT07219420. 

    To enroll in this study at USF, please contact USF Dermatology Research at (813) 493-3034.

Prurigo Nodularis

  • Currently Enrolling.

    The purpose of this study is to investigate the pharmacokinetics and safety of dupilumab in participants ≥6 months to <18 years of age with prurigo nodularis.

    Study medication: Dupilumab (subcutaneous injection)

    Requirements: 6 months to <18 years old. Must have ≥6 pruriginous lesions with a clinical diagnosis of PN at least 3 months prior to screening. Cannot have active moderate or severe lesions of atopic dermatitis or any other skin conditions that may interfere with the PN diagnosis. Cannot have had prior exposure to dupilumab.

    For more information, please visit https://clinicaltrials.gov/study/NCT06293053.

    To enroll in this study at USF, please contact USF Dermatology Research at (813) 493-3034.

Pyoderma Grangenosum

  • Currently Enrolling.

    The purpose of this study is to evaluate safety and efficacy of spesolimab (BI 655130) in adult patients with ulcerative pyoderma gangrenosum (PG) who require systemic therapy.

    Study medication: Spesolimab (IV infusion)

    Requirements: ≥18 years old, confirmed diagnosis of ulcerative PG, and at least 1 actively progressing PG ulcer (area between 5cm2 to 80cm2) 

    For more information, please visit https://clinicaltrials.gov/study/NCT06624670.

    To enroll in this study at USF, please contact USF Dermatology Research at (813) 493-3034.

Squamous Cell Carcinoma

  • Currently Enrolling.

    The main purpose of this study is to compare how well cemiplimab works compared to surgery, when injected into the lesion.

    Study medication: Cemiplimab (intralesional injection)

    Requirements: ≥18 years old with histologically confirmed invasive cutaneous squamous cell carcinoma. Lesion must be between 1cm and 2cm (longest diameter) and located on head, neck, hand, or pre-tibial surface.

    For more information, please visit https://www.clinicaltrials.gov/study/NCT06585410.

    To enroll in this study at USF, please contact USF Dermatology Research at (813) 493-3034.