Welcome to Sinclair DIRECT (Dermatology Investigational Research, Education and Clinical Trials)

From time to time, Sinclair Dermatology conducts clinical trials to test new treatments.  At these times, the clinic seeks participants who may be interested in being involved.  The major benefit for participants is being at the forefront of medical research and, potentially, finding relief for the conditions long before successful treatments become commonly available.  If you are interested in participating in future clinical trials ask your doctor for a referral to our East Melbourne clinic on 9654 2426 and request an appointment for a  clinical trial assessment.

Sponsor

Clinical Trial Title

Start Date

Amgen 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 June 2013
Novartis Pharmaceuticals A multicenter, double-blinded, randomized withdrawal extension study of subcutaneous secukinumab in pre-filled 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 Dec 2011
Novartis Pharmaceuticals A randomised, double-blinded, placebo-controlled, multicenter study to demonstrate the efficacy at 16 weeks of secukinumab 150 and 300 mg s.c. and to assess safety, tolerability and long term efficacy up to 132 weeks in subjects with moderate to severe palmoplantar psoriasis 22 Oct 2013
Novartis Pharmaceuticals A randomised, double-blinded, placebo-controlled, multicenter study to demonstrate the efficacy at 16 weeks of secukinumab 150 and 300 mg s.c. and to assess safety, tolerability and long term efficacy up to 132 weeks in subjects with moderate to severe nail psoriasis 24 Sep 2014
Novartis Pharmaceuticals A 52-week, multicenter, randomized, double-blinded study of subcutaneous secukinumab to demonstrate efficacy as assessed by Psoriasis Area and Severity Index at 16 weeks of treatment compared to ustekinumab and to assess long-term safety, tolerability and efficacy in subjects with moderate to severe plaque psoriasis 22 May 2014
Merck A 64-Week, Phase 3, Randomized, Double-Blind, 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-3222-010) 26 Apr 2013
Celgene A Phase 3B, multicenter, randomised, 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 13 Feb 2014
Coherus Biosciences A Double-blinded, randomised, parallel-group, active-control study to compare the efficacy and safety of CHS-0214 versus Enbrel in subjects with chronic Plaque Psoriasis (CHS-0214-04) (RaPsOdy) 23 Oct 2014
Coherus Biosciences An Open-Label Safety Extension Study (OLSES) Evaluating the Longterm Safety and Durability of Response of CHS-0214 Dec 2015
Janssen Research & Development 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 19 Feb 2015
Regeneron A randomised, double-blind, placebo-controlled study to demonstrate the efficacy and long-term safety of dupilumab in adult patients with moderate-to-severe atopic dermatitis 20 Mar 2015
Regeneron An Open Label Study of Dupilumab in Patients with Atopic Dermatitis who Participated in Previous Dupilumab Clincical Trials. April 2016
MedImmune A Phase 2b, randomized, double-blinded, placebo-controlled, dose-ranging study to evaluate the efficacy and safety of Tralokinumab in adult subjects with moderate-to-severe-atopic dermatitis 14 Apr 2015
Ascend Pharmaceuticals A Phase I/IIa Study of the Efficacy and Safety of ASN-002 in Adult Patients with Low-Risk Nodular Basal Cell Carcinoma (ASN-002-001). August 2015
Novartis Pharmaceuticals A multicenter, randomized, double-blind, placebo and active-controlled phase 2b dose-finding study of QGE031 as add-on therapy to investigate the efficacy and safety in patients with Chronic Spontaneous Urticaria (CSU) July 2015
Novartis Pharmaceuticals An open label, multicenter, extension study to evaluate the long-term safety of QGE031 240 mg s.c. given every 4 weeks for 52 weeks in Chronic Spontaneous Urticaria patients who completed study CQGE031C2201 May 2016
Glaxo Smith Kline Pharmaceuticals A Randomized, Double-Blind, PlaceboControlled, Parallel-Group Study to Investigate the Efficacy and Safety of Ofatumumab Injection for Subcutaneous Use in Subjects with Pemphigus Vulgaris August 2015
PPDI Open Label, Phase 2, Pilot Study Investigating the Safety, Clinical Activity, Pharmacokinetics and Pharmacodynamics of Oral Treatment with the BTK Inhibitor: PRN1008 in Patients with Pemphigus Vulgaris April 2016
Cutanea Life Sciences, Inc A Phase 3, Randomized, Vehicle-Controlled, Double-Blind, Multicenter Study to Evaluate the Safety and Efficacy of a Once-Daily CLS001 Topical Gel Versus Vehicle Administered for 12 Weeks to Subjects with Papulopustular Rosacea with a 4 Week Follow-up Period August 2015
Samson Clinical Pty Ltd A Phase 2b randomised, double-blind, placebo-controlled , dose ranging study to evaluate the efficacy and safety of oral minoxidil in adult male patients with Androgenetic Alopecia Sep 2015
Samson Clinical Pty Ltd Treatment of alopecia areata totalis with topical Janus Kinase (JAK) Inhibitors July 2015
Samson Clinical Pty Ltd Prevention of chemotherapy induced hair loss in women with breast cancer using a Paxman scalp cooling device July 2015
Boehringer Ingelheim BI 655066Risankizumab versus placebo in a multicenter randomized double-blind study in patients in moderate to severe chronic plaque psoriasis evaluating the efficacy and safety with  randomized withdrawal and re-treatment (IMMhance) May  2016
Pfizer A Phase 2b Randomized, Double-Blind, Placebo-Controlled, Parallel, Multicenter, Dose-Ranging, Study To Evaluate The Efficacy And Safety Profile Of Pf-04965842 In Subjects With Moderate To Severe Atopic Dermatitis June  2016
Merck, Sharp and Dohme A Phase III, Randomized, Placebo-Controlled, Parallel-Group, Double-Blind Clinical Trial to Study the Efficacy and Safety of MK-8931 (SCH 900931) in Subjects with Amnestic Mild Cognitive Impairment Due to Alzheimer’s Disease (Prodromal AD). March 2016
Oncobiologics #ONS-3010-002 – A Randomized, Double-Blind, Multicenter, Equivalence Study of ONS-3010 and Humira® for the Treatment of Patients with Moderate to Severe Plaque Psoriasis June  2016
Medimmune  A Phase 1b/2a, Randomized, Partial Double-blind, Single-dose, Active-controlled, Dose Ranging Study to Evaluate the Safety of  MEDI8852 in Adults with Acute, Uncomplicated Influenza. July  2016
Eli Lilly and Company A 24-month, multicentre, randomized, double-blind, placebo-controlled, parallel-group, efficacy, study, tolerability, biomarker, and pharmacokinetic study of AZD3293 in Early Alzheimer’s Disease (the AMARANTH Study) 2015