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 03 9654 2426 and request an appointment for a  clinical trial assessment.

Sponsor Clinical Trial Title Status
Botanix An Open-Label Study to Evaluate the Safety and Tolerability of BTX1503 Solution in Patients with Acne Vulgaris Recruiting
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) Ongoing
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 Ongoing
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 Ongoing
Regeneron An Open Label Study of Dupilumab in Patients with Atopic Dermatitis who Participated in Previous Dupilumab Clincical Trials. Ongoing
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). Ongoing
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 Ongoing
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 Ongoing
Samson Clinical Pty Limited 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 Ongoing
Samson Clinical Pty Limited Treatment of alopecia areata totalis with topical Janus Kinase (JAK) Inhibitors Ongoing
Samson Clinical Pty Limited Prevention of chemotherapy induced hair loss in women with breast cancer using a Paxman scalp cooling device Ongoing
Boehringer Ingelheim Risankizumab 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) Ongoing
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).
Ongoing
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) Ongoing
UCB Biopharma SPRL A Multicenter, Randomized, Double-Blind, Study To Evaluate The Time Course Of Pharmacodynamic Response, Safety And Pharmacokinetics Of Bimekizumab In Adult Subjects With Moderate To Severe Chronic Plaque Psoriasis Ongoing
Demira A Randomised, Double-Blind, Vehicle-Contollred, Efficacy And Safety Study Of Olumacostat Glasaretil Gel In Subjects With Acne Vulgaris Ongoing
Revian A Prospective, Randomized, Controlled, Double-Blind Study That Evaluates The Safety And Efficacy Of Three Active Revian Caps Versus A Non-Active Revian Cap (Sham) In Male Pattern Hair Loss (MPHL) Ongoing
Janssen Cilag “A Phase 3, Multicenter, Randomized, Double-Blind Study Evaluating The Comparative Efficacy Of CNTO 1959 (Guselkumab) And Secukinumab For The Treatment Of Moderate To Severe Plaque-Type Psoriasis. Ongoing
Novartis Cain457aau02 Study. Hope – Phase Iv, Open-Label, Single Arm, Non-Interventional, Exploratory Study Investigating The Health Related Psycho-Social Quality Of Life In Australian Patients With Severe Chronic Plaque Psoriasis Treated With Cosentyx (Secukinumab) Evaluated Using The Dlqi Ongoing
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 Completed
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 Completed
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 Completed
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 Completed
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 Completed
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 Completed
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) Completed
Coherus Biosciences An Open-Label Safety Extension Study (OLSES) Evaluating the Longterm Safety and Durability of Response of CHS-0214 Completed
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 Completed
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) Completed
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 Completed
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 Completed