Clinical Trials & Skin Studies

Clinical studies are ongoing to evaluate the efficacy of new therapeutic agents for variety of indications. The staff are experienced in topical, systemic and novel biologic therapeutics. They coordinate trials across multiple locations, including the NIH-funded General Clinical Research Center and the Ireland Cancer Center Infusion Unit. The Clinical Trials Unit (CTU) maintains a professional infrastructure for testing new agents and protocols for patients with skin diseases. The dermatology CTU provides a resource for industry and government for skilled assessment of skin disease. The Department has cultivated a very large pool of patients, both from within the institution and from a large referral base, who are regularly recruited into clinical trials, effecting rapid enrollment. The CTU is actively involved in study design, all phases of clinical testing, and the FDA approval process of investigational new drugs.

The Clinical Trials Unit of the Department of Dermatology provides patients with the opportunity to participate in studies of the newest medications that are being evaluated as potential therapies. Past projects include trials in psoriasis, eczema, skin lymphoma, melanoma, shingles, pemphigus, bullous pemphigoid, alopecia, acne, warts, fungal infections, onychomycosis, tinea pedis/cruris/versicolor, herpes zoster, genital warts, postherpic neuralgia, Kaposi's sarcoma, graft vs. host disease, urticaria, and photoaging. All patients seen in our practice are eligible to enroll in such studies which are funded by pharmaceutical, private, or governmental sources.

Current Studies
  1. A Phase 3 Open-Label Study of the Safety and Efficacy of Adalimumab in Subjects with Moderate to Severe Hidradenitis Suppurativa (Abbott M12-555)
     
  2. A Phase 3 Study to Evaluate the Efficacy and Safety of Induction and Maintenance Regimens of Brodalumab Compared With Placebo and Ustekinumab in Subjects With Moderate to Severe Plaque Psoriasis:  AMAGINE-3
     
  3. A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, EFFICACY AND SAFETY STUDY OF APREMILAST (CC-10004) IN SUBJECTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS
     
  4. A PHASE 3B, MULTICENTER, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND, DOUBLE-DUMMY, STUDY OF THE EFFICACY AND SAFETY OF APREMILAST (CC-10004), ETANERCEPT, AND PLACEBO, IN SUBJECTS WITH MODERATE TO A PHASE 3B, MULTICENTER, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND, DOUBLE-DUMMY, STUDY OF THE EFFICACY AND SAFETY OF APREMILAST (CC-10004), ETANERCEPT, AND PLACEBO, IN SUBJECTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS
     
  5. A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTIPLE-DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND EFFICACY OF CIM331 IN ATOPIC DERMATITIS PATIENTS WHO ARE INADEQUATELY CONTROLLED BY OR INTOLERANT TO TOPICAL A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTIPLE-DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND EFFICACY OF CIM331 IN ATOPIC DERMATITIS PATIENTS WHO ARE INADEQUATELY CONTROLLED BY OR INTOLERANT TO TOPICAL THERAPY
     
  6. Kyowa Hakko Kirin Pharma, Inc. / “Open-Label, Multi-Center, Randomized Study of Anti-CCR4 Monoclonal Antibody KW 0761 (mogamulizumab) Versus Vorinostat in Subjects with Previously Treated Cutaneous T-Cell Lymphoma”
     
  7. A Multicenter Study with a Randomized, Double-Blind, Placebo-Controlled Induction Dosing Period Followed by a Randomized Maintenance Dosing Period and a Long-Term Extension Period to Evaluate the Efficacy and Safety of LY2439821 in Patients with Moderate to-Severe Plaque Psoriasis
     
  8. A 52-Week, Phase 3, Randomized, , Active Comparator and Placebo-Controlled, Parallel Design Study to Evaluate the Efficacy and Safety/Tolerability of Subcutaneous SCH 900222 / MK-3222, Followed by an Optional Long-Term Safety Extension Study, in Subjects With Moderate-to-Severe Chronic Plaque Psoriasis (Protocol No. MK-3222-011)
     
  9. A Randomized, Double-Blind, Placebo Controlled, Study Investigating Vaccine Responses in Adults with Moderate to Severe Atopic Dermatitis Treated with Dupilumab
     
  10. A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF TOFACITINIB (CP-690,550) IN SUBJECTS WITH ACTIVE PSORIATIC ARTHRITIS AND AN INADEQUATE RESPONSE TO AT LEAST ONE TNF INHIBITOR
     
  11. A PHASE 3, MULTI-SITE, OPEN-LABEL STUDY OF THE LONG TERM SAFETY AND TOLERABILITY OF 2 ORAL DOSES OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE CHRONIC PLAQUE
     
  12. Comparative Effectiveness of Psoriasis Treatments on Systemic Inflammation
     
  13. A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP, STUDY FOLLOWED BY A DOSE-BLIND PERIOD AND OPEN-LABEL FOLLOW-UP TO EVALUATE THE EFFICACY AND SAFETY OF CERTOLIZUMAB PEGOL IN SUBJECTS WITH MODERATE TO SEVERE CHRONIC PLAQUE PSORIASIS
     
  14. A Randomized, Double-Blind, Placebo Controlled, Parallel, 3-Arm Study of the Safety and Anti-Pruritic Efficacy of Nalbuphine HCl ER Tablets in Prurigo Nodularis Patients
     
  15. PROVE: A PROspective, observational, US-based study assessing outcomes, adverse events, treatment patterns, and quality of life in patients diagnosed with mycosis fungoides cutaneous T-cell lymphoma and treated with Valchlor
     
  16. I1F-MC-RHBP: A Multicenter, Randomized, Double-Blind Study Comparing the Efficacy and Safety of Ixekizumab Dosing Regimens in Patients with Moderate-to-Severe Plaque Psoriasis
     
  17. Efficacy of Ustekinumab (Anti-IL-12/23) followed by Abatacept (CTLA4-Ig) for the Treatment of Psoriasis Vulgaris
     
  18. Post-Approval Study of MelaFind 
     
  19. A LONG-TERM, OPEN-LABEL EXTENSION STUDY OF TOFACITINIB (CP-690,550) FOR THE TREATMENT OF PSORIATIC ARTHRITIS
     
  20. Evaluation of Cardiovascular Risk Profile in Psoriasis Patients by the Use of Pro-inflammatory Markers in Skin and Cardiovascular Disease
     
  21. Sleep, Circadian Rhythm and Skin Health
     
  22. Effect of Etanercept on UV-induced contact sensitivity suppression in psoriasis patients
     
  23. Effect of ACCS in UV-induced inflammation

For more information regarding our clinical trials, please call 216-844-5197.

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