Dermatology

Clinical Trial Trends

Welcome to our site for Dermatology Clinical Research.   First, we would like to introduce our Research Study Coordinators to those who haven’t had a chance to meet them.

Seli Gyau has worked in our Clinical Research Unit for five years. She is originally from Ghana, West Africa. Seli moved to Des Moines, Iowa during college and holds a Master’s degree in experimental pathology from New York Medical College. She began doing bench research in 2008 and transitioned into clinical research 8 years ago. At UTSW she coordinates both clinical trials and biorepository studies.

Seli also has the task of educating PI’s and providers on how to navigate the clinical trial process. Seli is involved in the entire trial process all the way from the Budget negotiations, Contracts, PI meetings, subject recruitment, IRB submissions and through to completion of the studies.  Seli is married with 2 children and a new baby due to arrive in May. Her future plans include medical school.
 

She is assisted by Dorothy Bell, a part-time study coordinator.

 

Dorothy started at the University of Texas Southwestern Medical Center in 2001 as a Sr. Administrative Assistant. In 2012, she joined the Simmons Cancer Center as a Regulatory Associate. Dorothy retired from UT Southwestern in 2019. We’re very lucky that she has come out of retirement to support our Clinical Research Unit.

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Total number of active trials: ***

Total number of trials in recruitment: ***

Total number of biorepository studies: ***

Total number of trials starting recruitment this summer: ***

Total number of biorepository Registries studies: *** 

Updates on Current Studies

Dr. Dominguez has an active study titled A Randomized, Multicenter Study for Isolated Skin Vasculitis (ARAMIS)

Drs. Dominguez and Yancey have an active trial for Pemphigus although the study is no longer recruiting patients

Dr. Le is currently recruiting for a phase 2 industry sponsored study of a topical cream for treatment of Neurofibromatosis Type 1 (NF1). Enrollment for 15 subjects began in October.

Drs. Ayoade and Vasquez have closed recruitment for two separate vitiligo clinical trials in 2020 (Pfizer & Incyte).  The Incyte study was a 2 ½ year clinical trial of a topical cream for vitiligo which has shown great promise for vitiligo patients. The topical cream will hopefully gain FDA approval in 2022. 

Upcoming Clinical Trials

Dr. Chong has the following upcoming trials;

  1. Pfizer –A PHASE 2 DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF PF-06823859 IN ADULT SUBJECTS WITH DERMATOMYOSITIS
  2. Amgen: A Phase 2b Dose Ranging Study to Evaluate the Efficacy and Safety of Efavaleukin Alfa in Subjects with Active Systemic Lupus Erythematosus with Inadequate Response to Standard of Care Therapy

Dr. Mauskar has the following upcoming trial.

  1. Natiens-A research study to determine whether two therapeutic interventions - cyclosporine and etanercept - will improve short-term outcomes associated with Stevens-Johnson Syndrome and toxic epidermal necrolysis (SJS/TEN) over normal standard of care.

Sponsor Contact

Pfizer and GlaxoSmithKline (GSK) has reach out to the department for Investigators in the following trials. Please reach out to Seli Gyau if you are Interested.

  1. Pfizer- A phase 3 clinical study for patients with non-segmental vitiligo. The primary objective of the B7981040 study is to evaluate the efficacy and safety of ritlecitinib compared to placebo.
  2. Phase 1b study of a new GSK medicine in moderate to severe atopic dermatitis patients

Coming Soon

Seli and Dorothy are working on a powerpoint presentation and tip sheet regarding Regulatory & Research compliance for all providers, fellows, faculty, etc.   Hopefully, this will help everyone navigate the changing landscape of clinical research at UT Southwestern.