Clinical Trials

The Clinical Trials Unit does investigator-initiated and industry-sponsored clinical studies of new dermatologic therapies in human subjects. The unit covers the full spectrum of clinical studies from Phase One through Phase Four. Most studies are multi-center, and some are conducted only at UBC. The unit is part of the University of British Columbia and the Vancouver General Hospital. Clinical trials have been conducted previously on all of the major therapeutic areas of dermatology, including acne, psoriasis, eczema, warts, skin cancer,  and hair disorders. There have also been medical clinical studies, surgical clinical studies, and cosmetic clinical studies.

In a scientifically rigorous environment, the following questions are answered in Clinical Trials:

• Is this new therapy safe?
• Is this new therapy effective?
• How much more effective is this new therapy than what is currently available?
• What’s the best way to use this new therapy?

Location

We are centrally located in Vancouver, British Columbia; approximately 20-30 minutes from Vancouver International airport, in The Skin Care Centre.

Staff

Dr. Jan Dutz and Dr. Sunil Kalia are the Directors of Clinical Trials at the Skin Care Centre. We are able to draw from our pool of faculty members at the Department of Dermatology and Skin Science, Faculty of Medicine, University of British Columbia. Our site further benefits from additional patient population from the part-time faculty dermatologists in the Greater Vancouver area. The facility is staffed with 3 full-time and one part time Clinical Research Coordinators.

Investigators

Fields/Objectives of Clinical Research in Dermatology

• Clinical evaluations for safety and efficacy
• Dose-determining studies
• Clinical Trials for OTC monograph
• Clinical Trials for prescription drugs

Therapeutic Areas of Clinical Research

Facilities

We have a dedicated clinical trial facility that includes: underground parking for patients, a waiting room, 3 examination rooms, a monitor’s room (equipped with a telephone, internet connection), an administration office, a secure supplies room for Investigative Product, secure storage for study material.

Ongoing Clinical Trials – January 2015

• Safety and efficacy of escalating doses of LEO 43204 applied once daily for two consecutive days on approximately 250 cm2 on trunk and extremities in subjects with actinic keratosis
• A Randomized, Double-Blind, Placebo-Controlled Study to Demonstrate the Efficacy and Long-Term Safety of Dupilumab in Adult Patients with Moderate-to-Severe Atopic Dermatitis (R668-AD-1224)
• A Phase 3, Multicenter, Randomized, Double-blind, Placebo and Active Comparator-controlled Study Evaluating the Efficacy and Safety of Guselkumab for the Treatment of Subjects with Moderate to Severe Plaque-type Psoriasis (VOYAGE 1)
• A Phase 3, Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Guselkumab for the Treatment of Subjects With Moderate to Severe Plaque-type Psoriasis and an Inadequate Response to Ustekinumab (NAVIGATE)
• An Open-Label Study of Dupilumab In Patients with Atopic Dermatitis Who Participated In Previous Dupilumab Clinical Trials (R668-AD-1225)
• Clinical Study Protocol W14-406. Concomitant longitudinal evaluation of adalimumab with methotrexate in the real world: the CLEAR study.
• Omalizumab (Xolair®) is a recombinant humanized monoclonal antibody that selectively binds to free IgE and prevents it binding to the high affinity IgE receptor (FcεR1). As a result, cross linking of the receptor by antigen is prevented, the release of inflammatory mediators decreases, and FcεR1 density on basophils and mast cells is reduced.
• A 64-Week, Phase 3, Randomized, 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 (MK-3222-010)
• A 12-Week Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Efficacy and Safety of LY2439821 to Etanercept and Placebo in Patients with Moderate to Severe Plaque Psoriasis with a Long-Term Extension Period (I1F-MC-RHBC)
• 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 (20120104)
• MIKIE – A Randomized, Double-Randomized,, Double-Blinded, Regimen-Controlled, Phase II, Multicenter Study to Assess the Efficacy and Safety of Two Different Vismodegib Regimens in Patients with Multiple Basal Cell Carcinomas (M028295)
• A multicenter, double-blind, randomized withdrawal extension study of subcutaneous secukinumab in prefilled syringes to demonstrate long-term efficacy, safety and tolerability up to 4 years in subjects with moderate to severe chronic plaque-type psoriasis completing preceding psoriasis phase III studies with secukinumab (CAIN457A2302E1).
• A Multicenter, Open Registry of Patients with Psoriasis Who Are Candidates for Systemic Therapy Including Biologics (C0168Z03/PSOLAR).
• A 10-Year, Post-marketing Observational Registry of HUMIRA® (adalimumab) in Adult Patients with Chronic Plaque Psoriasis (PS) (P10-023/ESPRIT).
• 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 Psoriasis (A3921061)
• A Phase 3, Multicenter, Randomized, Double-Blind Study Evaluating the Efficacy and Safety of ABP 501 Compared with Adalimumab in Subjects with Moderate to Severe Plaque Psoriasis (20120263)