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Sinclair Dermatology has conducted more than 100 global clinical trials that investigate new treatments for dermatological conditions. A number of these trials have successfully progressed to TGA approval for treatment and made easily accessible to the public. Our team is proud to be involved in advancing dermatology treatment and continue to strive for better future health outcomes.

Our dedicated clinical trials team are experts in conducting Phase I through to Phase IV dermatological clinical trials. These include studies in promising medications and medical devices. Our experience and high level of commitment to each trial allows for the collection of valuable research data and further the development of potential treatments for a vast range of skin, hair and nail conditions.

Our state-of-the-art facilities include private clinical consultation rooms, specialised photography and an in-house pharmacy. Our clinical trials team are focused on ensuring the best patient experience.

Current Clinical Trials

Please click here to register your interest in one of our clinical trials. One of our recruitment specialists will be in touch shortly.

All trials are open to Victorian residents. Treatment and study care will be provided free of charge to eligible participants during the course of the trial.

Skin Trials

Condition Age Severity Eligibility Status Registration
Atopic Dermatitis-Eczema (AD) – Adults 18+ Mild, Moderate and Severe Clinical diagnosis of Atopic Dermatitis. OPEN Register Now Speak To Us
Atopic Dermatitis-Eczema (AD) – Teens 12+ Moderate to Severe Clinical diagnosis of atopic dermatitis. OPEN Register Now Speak To Us
Chronic Spontaneous Urticaria (CSU) – Adults 18+ Chronic Clinical Diagnosis of CSU for at least 6 months. OPEN Register Now Speak To Us
Chronic Plaque Psoriasis (CPP) – Adults 18+ Moderate to Severe Clinical Diagnosis of Chronic Plaque Psoriasis OPEN Register Now Speak To Us
Cutaneous Lupus Erythematosus (CLE) – Adults 18 - 80 Moderate to Severe Histologically confirmed and documented diagnosis of Cutaneous Lupus Erythematosus. OPEN Register Now Speak To Us
Gorlin Syndrome (GS) – Adults 18+ N/A Clincial diagnosis of Gorlin Syndrome. OPEN Register Now Speak To Us
Hidradenitis Suppurativa (HS) – Adults 18+ Mild, Moderate and Severe Clinical diagnosis of Hidradenitis Supparativa. OPEN Register Now Speak To Us

Nail Trials

Condition Age Severity Eligibility Status Registration
Nail Psoriasis (NPSO) – Adults 18+ Moderate to Severe Victorian residents.
Clinical Diagnosis of Nail Psoriasis
OPEN Register Now Speak To Us

Hair Trials

Condition Age Severity Eligibility Status Registration
Male and Female Patterned Hair Loss (MPHL, FPHL) All All Victorian residents.
We are seeking expressions of interest for upcoming male and female patterned hair loss clinic trials. Please register your interest so we can notify you once a clinical trial becomes available.
Taking expression of interest. Register Now Speak To Us

What Is a Clinical Trial?

Clinical trials (also known as clinical studies) are conducted to learn about the safety and effectiveness possible biomedical interventions (new medications, medical devices, and medical procedures) can have on people in the real world.

Clinical trials are essential to the development of new interventions. For example, without clinical trials, we cannot properly determine whether new medicines developed in the laboratory or by using animal models are effective or safe, or whether a diagnostic test works properly in a clinical setting. This is because computer simulation and animal testing can only tell us so much about how a new treatment might work and are no substitute for testing in a living human body.

Clinical trials also permit testing and monitoring of the effect of an intervention on a large number of people to ensure that any improvement as a result of the intervention occurs for many people and is not just a random effect for anyone.

Most modern medical interventions are a direct result of clinical research. New interventions for most diseases and conditions have been developed through clinical research. Clinical trials often lead to new interventions becoming available that help people to live longer and to have less pain or disability .

Source: https://www.australianclinicaltrials.gov.au/what-clinical-trial

dermatology clinical trial

Phases of Clinical Trials

Clinical trials of biomedical interventions (new medications) typically proceed through four different stages, which are called "phases". In the early phases, the new intervention is tested in a small number of participants to assess safety and effectiveness. If the intervention is promising, it may move to later phases of testing where the number of participants are increased to collect more information on effectiveness and possible side effects. All new drugs must be tested in phase I, II and III studies before being approved for use by the public. Phase IV is done after the drug has been approved by the Therapeutic Goods Administration (TGA).

Preclinical

Test how a body responds to an experimental drug. In these studies, small doses of the new drug are tested in the research laboratory or in small animals.

Phase 1
>20-80 people

Evaluate how safe the medicine is and how it interacts with the human body. Typically, these trials are very short, and very tightly controlled with a high degree of monitoring of participants.

Phase 2
>100 people

Determine the efficacy (that is, whether it works as intended) and to further evaluate its safety in a larger group of people. Typically, these trials are placebo-controlled, fairly short and participants are closely monitored.

Phase 3
>1000 people

Further evaluate safety and efficacy of an intervention in large groups of trial participants comparing the new drug to placebo or other standard interventions for the condition. Participants are monitored closely.

Phase 4
TGA approved
& Marketed

Monitor the effectiveness of the approved intervention in the general population and to collect information about any adverse effects associated with widespread use over longer periods of time.

Sinclair Dermatology is committed to excellence in patient care, clinical research and to the
development of new treatments that improve our patients' lives. We conduct trials at different phases.
For more information on clinical trial phases, please visit: https://www.australianclinicaltrials.gov.au/what-clinical-trial/phases-clinical-trials

Types of Clinical Trials

Although there are different types of clinical trials, all must conform to strict rules set by country-specific regulatory. In Australia, the bodies responsible for the regulation for assessing and monitoring clinical trials are the Human Research Ethics Committees (HREC), the pharmaceutical companies running the clinical trials and the Therapeutic Goods Administration (TGA).

Sinclair DIRECT works with local and international pharmaceutical companies to conduct trials in a broad range of skin conditions. All research is conducted in accordance with International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) guidelines. Ensuring the safety and comfort of all our trial participants is our upmost priority.

Sponsor-led Trials

Sponsor-led trials are clinical trials that are initiated by drug or device companies who have developed a new treatment. The companies or also known as “Sponsors” engage a contract research organisation (CRO) to act on their behalf to ensure the trial runs smoothly and in accordance with ICH-GCP guidelines.

Investigator-led Trials

Investigator-led trials are clinical trials initiated by individual or groups of health care practitioners such as doctors or medical research entities. These trials may be funded by a research organisation, grants from research funding bodies, or by the doctors themselves.

Participants Journey

participant journey step 1

Expression of interest and pre-screening/phone screening

  • Complete online questionnaire to express your interest in a study or to discuss eligibility with one of our Study Coordinators (SC).
  • When a suitable trial is identified, we can book you in for an assessment with one of our Study Doctors. Your SC will inform you of any documents you may need to bring.
participant journey step 2

Screening appointment on site at Sinclair Dermatology

  • Chat with our Study Doctor about the study and ask any questions you may have.
  • If you are still interested, we will conduct a formal consent process.
  • A thorough assessment will be conducted, we will chat with you about your current and prior medication your health history and any other requirements for the study.
participant journey step 3

Commencement of
trial participation

  • At this visit you will undergo final review of eligibility. If all eligibility requirements are met, you will receive your first study medication.
  • This may be a long visit as we’d like to stay around after your first dose to make sure you are OK.
participant journey step 4

Reimbursement
 

  • There is no cost to you to participate in a clinical trial
  • For most studies, a reimbursement of your time and travel expenses will be provided.

Why Should I Participate In a Clinical Trial?

Clinical trials offer the hope of developing better interventions or tests for a particular disease or condition. Even if a trial does not provide a benefit for an individual, it may provide benefits for others with the disease in the future. Clinical trials often lead to new interventions becoming available that help people to live longer and to have less pain or disability.

Some of the possible advantages of participating in a clinical trial may include:

  • to be at the forefront of medical research
  • potentially finding relief for your condition long before successful treatments become readily available
  • receive all medication and regular medical checks free of charge during the study
  • contribute to the advancement of scientific knowledge that could help many others with the same disease or condition now and in the future
  • a way to give back to the community

If you are interested in participating in one of our clinical trials please answer a few short questions via the below link and one of our recruitment co-ordinators will be in contact with you shortly: eligibility questionnaire.

Common Questions

About Sinclair DIRECT

In 2010, Sinclair Dermatology established Australia’s largest dedicated Dermatology Investigational Research Education, and Clinical Trials Centre (DIRECT) to reinforce its commitment to excellence in patient care, clinical research and to the development of new treatments to improve patients’ lives.

DIRECT is Australia’s only dedicated dermatology clinical research centre and the leader in dermatology education for dermatologists, dermatology trainees, general practitioners, medical students, other medical professionals and involved in the 2021 World Congress of Hair Research and the International Society of Dermatology World Congress.

Since its formation, DIRECT has conducted more than 100 sponsored Phase I, Phase II, Phase III and Phase IV clinical trials in the following dermatological conditions:

  • Acne
  • Alopecia areata
  • Atopic dermatitis
  • Basal cell skin cancer
  • Chemotherapy-induced hair loss
  • Melanoma detection/mole and skin scanner
  • Male pattern hair loss
  • Female pattern hair loss
  • Frontal fibrosing alopecia/lichen planopilaris
  • Hidradenitis suppurativa
  • Pemphigus vulgaris
  • Psoriasis
  • Psoriatic arthritis
  • Rosacea
  • Urticaria
  • Vitiligo

All research conducted at Sinclair DIRECT are in accordance with the ICH Good Clinical Practice Guidelines and the protocol for the conduct of clinical trials has been examined and approved by Human Research Ethics Committee. DIRECT has been inspected by the European Medicines Agency (EMA) with no critical findings as well as having participated in number of sponsor- initiated audits, with no critical findings.

DIRECT is the only clinical trials centre in the world to have the Canfield VECTRA WB360 whole-body skin imaging system, which was designed specifically for dermatology. The VECTRA WB360 is invaluable for helping calculate affected skin surface areas and monitors changes to a participant’s condition over time.

DIRECT@ Sinclair Dermatology works with local and international pharmaceutical companies to conduct sponsored clinical trials in a broad range of skin diseases. DIRECT also conducts investigator-initiated clinical studies and fundamental research into skin biology and disease mechanisms. We bring together the best team of more than 20 laboratory and clinical researchers, who are all dedicated to improving the lives of people affected by skin disease. We strive to provide better treatments, better care and progressively moving towards finding a cure for skin diseases and skin cancer.

Read More

About our investigational research

Our laboratory research involves gene discovery, cell culture and stem cell biology and hair follicle cloning. We have published more than 500 papers in high-impact journals including the New England Journal of Medicine, The Lancet, Nature Genetics, British Medical Journal, EMBO, Journal of Investigative Dermatology, Experimental Dermatology, British Journal of Dermatology, Journal of the American Academy of Dermatology, international Journal of Dermatology, Journal of the European Academy of Dermatology and Australasian Journal of Dermatology.

Team

Principal Director

  • Professor Rod Sinclair

Clinical Trials Unit Manager

  • Dr Carol Robinson

Scientific Research and Clinical Trials Governance Manager

  • Ms Laita Bokhari

Principal Investigators

  • Professor Rod Sinclair
  • Dr Samantha Eisman
  • Dr Bevin Bhoyrul

Sub-Investigators

  • Dr Michaela Bennett
  • Dr Leila Asfour
  • Dr Georgina Hollmann
  • Dr Anthony Moussa
  • Dr Andrew Awad
  • Dr Ivana Chim

Team
The trials unit has clinical trials fellows and an experienced team of clinical trials coordinators, nurses and assistants who assist in the operation of the department.

Prof. Rod Sinclair

Prof. Rod Sinclair

Research Director &

Principal Dermatologist

Dr. Samantha Eisman

Dr Samantha Eisman

Principal Investigator &

Consultant Dermatologist

Dr Bevin Bhoyrul

Principal Investigator &

Consultant Dermatologist

Dr. Carol Robinson

Dr Carol Robinson

Clinical Trials
Unit Manager

Laita Bokhari

Scientific Research & Clinical
Trials Governance Manager

DIRECT is Australia’s only dedicated dermatology clinical research centre and the only clinical trials centre in the world to have the Canfield VECTRA WB360 whole-body skin imaging system, which was designed specifically for dermatology. The images produced provide sponsors with the most accurate information possible on clinical response.

Our management team oversees the centre that comprises doctors, nurses, pharmacists, clinical trial coordinators and assistants.

  • Research Director & Principal Investigator: Prof. Rod Sinclair (MBBS, MD, FACD)
  • Principal Investigator: Dr Samantha Eisman (MBChB, FACD)
  • Clinical Trials Unit Manager: Dr Carol Robinson (PhD)
  • Research Scientist & Projects Manager: Ms Laita Bokhari (MPhilMed)
  • Clinical Trials Operations Manager: Ms Megan Defazio

Facilities

We provide high-quality facilities and equipment for on-site monitoring

  • Three dedicated consulting rooms
  • Conference/meeting room
  • Secure authorised access to clinical trials administration area
  • Dedicated locked cold-chain monitored refrigerators (ambient temperature, 2-8°C) and freezers (-20°C and -80°C)
  • Electrocardiogram (ECG)
  • Centrifuge
  • Incubators
  • Dedicated sample processing area
  • Use of electronic and paper records
  • High-speed internet

Capabilities

  • All research conducted at Sinclair DIRECT are in accordance with the ICH Good Clinical Practice Guidelines
  • The protocol for the conduct of clinical trials has been examined and approved by Human Research Ethics Committee.
  • Sinclair DIRECT has been inspected by the European Medicines Agency (EMA) with no critical findings
  • Sinclair DIRECT has participated in a number of sponsor-initiated audits, with no critical findings
  • Sinclair DIRECT regularly surpasses recruitment targets

Companies We Have Worked With

parexel
sun pharma
janssen
abbvie
botanix
photon md
boehringer
ascend

Accreditations & Memberships

Australasian Hair and Wool Research Society
victoria
international academy cosmetic dermatology
european medecines agency
gpce
deakin university
congress dermatology
bellberry limted
australiasian college dermatologists
australian government national health
australian government ip
australian clinical trials
asdr
albinism fellowship australia
aaaf
ahsf
american dermatological association
british association of dermatology
epworth
international society of dermatology
university of melbourne

Clinical Trials Unit Opening Hours

Mon: 8:30am – 4:30pm
Tue: 8:30am – 4:30pm
Wed: 8:30am – 4:30pm
Thu: 8:30am – 4:30pm
Fri: 8:30am – 4:30pm
Sat: Closed
Sun: Closed

 

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