NYU Clinical Studies Unit

The NYU Clinical Studies Unit of the Ronald O. Perelman Department of Dermatology is located in the Charles C. Harris Skin and Cancer Pavilion at Tisch Hospital. Established in the 1970s, the Unit has developed into one of the nation's most distinguished clinical research centers in dermatology. Our mission is to advance the understanding of the mechanisms of skin disease acquired through basic and clinical research and apply them by utilizing novel therapeutic interventions. The Unit is primarily responsible for carrying out clinical trials relating to inflammatory skin diseases, skin cancer, infections, and auto-immune illnesses.

Clinical trials are research studies designed to investigate the effectiveness and safety of new therapies for diseases in human subjects. This not only advances the potential treatment options for patients suffering from skin disease, but also promotes greater understanding into the possible causes and natural evolution of acute and chronic illnesses.

Clinical studies conducted at the Unit may be funded through a variety of sources including government agencies such as the FDA (Food and Drug Administration, NIH (National Institutes of Health), and CDC (Centers for Disease Control and Prevention), pharmaceutical companies, disease specific foundations such as the National Psoriasis Foundation, the National Alopecia Areata Foundation, the Lupus Foundation, etc, and philanthropic individuals and organizations.

Often, clinical trials performed at the NYU Clinical Studies Unit result in data and new knowledge that provide the necessary information required for approval of drugs for use in the United States and worldwide. Individuals in our clinical trials may participate in a variety of trial types and designs. They may involve medications or interventions designed to prevent, diagnose, or treat the wide variety of diseases that afflict the skin, hair, nails, and mucous membranes.

Throughout our long history, we have performed all phases of human clinical trials. These are often referred to as Phase 1, 2, 3, or 4 and relate to the degree of prior information that is available for a specific drug or treatment. Phase 1 and 2 trials aim to establish safety and evaluate a drug’s interaction in the human body , while phase 3 trials establish effectiveness and further study the safety of new treatments. Phase 4 studies usually involve existing, approved mediations that may be used in new ways.

Our Clinical Studies Unit focuses primarily on clinical trials in individuals suffering from common skin illnesses such as psoriasis, atopic dermatitis/eczema, alopecia (hair loss), acne, skin cancer, and skin infections. Rarer diseases including autoimmune illnesses like skin lupus, pemphigus vulgaris, and cutaneous T-cell lymphoma are also studied.

The safety of our patients is of utmost importance to us. Patients are carefully monitored by study physicians and all clinical trials are approved of by our Institutional Review Board. Prior to entering into a clinical trial, patients generally meet with a member of our unit to discuss the study design and their suitability and eligibility to participate. Should an investigational trial be appropriate, individual will be presented with an informed consent package for them to review and sign. This will give the prospective patient information about the study, investigational drug or therapy, patient’s rights and their responsibilities as a partner in their participation in this important scientific endeavor.