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Skin Health Institute

Clinical Trials - For Clinicians

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These research study descriptions are intended for clinicians only. Information for potential study participants can be found here

If you would like to learn more about any of the studies currently being conducted at the Skin Health Institute, please contact the nominated study coordinator.

If you have any general questions regarding the clinical trials conducted at the Institute, please feel free to contact the Clinical Trials Department at [email protected] or by phone on (03) 9623 9439.

Atopic Dermatitis

Atopic Dermatitis

Nail Psoriasis

Melanoma Research Study

ATOPIC DERMATITIS (22 WEEKS)

Title

A phase 2 trial to evaluate the efficacy and safety of orally-administered LEO 152020 tablets compared with placebo tablets for up to 16 weeks of treatment in adults with moderate to severe atopic dermatitis; A randomized, triple-blind, placebo-controlled, parallel-group, international trial.

Background and Rationale

Atopic dermatitis (AD), often referred to as eczema, is a chronic, inflammatory skin disease characterized by widespread skin lesions (manifested as red, itchy, swollen, cracked, weeping lesions with crusting/scaling), intense pruritus (itch), and a general deterioration in quality of life. The medication under investigation in this study, LEO 152020, binds selectively to human H4R and has been characterized as antagonist, inhibiting both the intrinsic activity and the histamine-induced effects of the H4R.  Research on H4R has shown that H4R antagonists have anti-pruritic and anti-inflammatory effects, making H4R a novel therapeutic target in AD.

Purpose

This trial will provide information on the efficacy and safety of LEO 152020 and on the exposure-response relationship of LEO 152020, allowing identification of effective dose(s).

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Atopic Dermatitis (33 weeks)

Title

A Multi-centre, Randomized, Double-blind, Placebo-controlled, Dose ranging Trial to evaluate the efficacy and safety of ASLAN004 Subcutaneously Delivered ASLAN004 in Adults with Moderate-Severe Atopic Dermatitis.

Background and Rationale

Atopic dermatitis (AD) is a common, chronic, inflammatory skin disorder characterized by flaky skin lesions.  Key symptoms of moderate to severe disease include severe itching, poor sleep, psycho-social dysfunction, and an impact on quality of life.  ASLAN004 is a fully human monoclonal immunoglobulin G4 (IgG4) antibody that binds specifically to the IL-13Rα1 subunit, to block the signalling of both IL-4 and IL-13 through the Type II receptor.  This prevents the release of pro-inflammatory cytokines, chemokines, and IgE, all of which contribute to allergic/atopic disease mechanisms.

Purpose

This clinical study is designed to evaluate dose ranging ASLAN004 versus placebo in patients who have moderate to severe AD.

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Nail Psoriasis (76 weeks)

Title

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Assess the Efficacy and Safety of Tildrakizumab in the Treatment of Moderate to Severe Nail Psoriasis (CT.gov ID: NCT03897075).

Background and Rationale

Psoriasis is a chronic inflammatory skin disorder and affects approximately 1% to 2% of people worldwide. Nail psoriasis occurs in approximately 50% of patients with plaque psoriasis and is associated with pain and discomfort, causing a significant burden to quality of life (QoL) and work function. Recent studies have demonstrated that IL-23-dependent T-helper (Th)17 cells control much of the inflammatory damage that is observed in psoriasis. Based on this rationale, several therapeutic anti-IL-23 antibodies were developed and entered into clinical studies. Tildrakizumab, an anti-IL 23p19 antibody, demonstrates comparable efficacy in psoriasis to other biological compounds in the IL-23 pathway. It has a favorable safety profile, and convenient dosing at Weeks 0, 4, and every 12 weeks after that.

Purpose

The purpose of this study is to assess the efficacy and safety of tildrakizumab in the treatment of moderate to severe nail psoriasis.

  • Condition:
    • Chronic Plaque Psoriasis
    • Moderate to Severe Nail Psoriasis
  • Intervention:
    • Drug: Tildrakizumab
    • Other: Placebo
  • Phase: 3
  • Study Type: Interventional (Clinical Trial)
  • Study Design:
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Masking: Double (Participant, Investigator)
    • Primary Purpose: Treatment

Eligibility

  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult) 
  • Sexes Eligible for Study: All 
  • Accepts Healthy Volunteers: No 

Key Inclusion Criteria

  • Participants should be 18 years or older at the time of signing the informed consent during the Screening visit.
  • Participants with a chronic moderate to severe plaque-type psoriasis for at least 6 months (as determined by participant interview and confirmation of diagnosis through physical examination by Investigator).
  • Participants must have moderate to severe nail psoriasis at Screening and Baseline, defined by:
    • mNAPSI score of ≥20
    • ViSENPsO ≥3
  • Participants must have moderate to severe plaque psoriasis at Screening and Baseline, defined by:
    • s-PGA score of at least 3
    • Body Surface Area (BSA) involvement of ≥10%
    • PASI ≥12
  • Participants must be considered candidates for systemic therapy, meaning psoriasis is inadequately controlled by topical treatments (corticosteroids), and/or phototherapy, and/or previous systemic therapy.
  • Participants are unlikely to conceive, as indicated by "Yes" to at least one of the following questions:
    • Participant is a male
    • Participant is a female and agrees to abstain from heterosexual activity OR use a highly effective method of contraception:
      • combined (estrogen and progestogen containing) hormonal contraception – oral, intravaginal, transdermal
      • progestogen-only hormonal contraception – oral, injectable
      • implantable progestogen-only hormonal contraception – intrauterine device, intrauterine hormone-releasing system (IUS), bilateral tubal occlusion
      • vasectomized partner
      • sexual abstinence
    • Male participants with female partners of childbearing potential who are not using birth control as described above must use a barrier method of contraception (e.g. condom) if not surgically sterile (i.e. vasectomy)
    • Participant is a surgically sterilized female or is documented to be postmenopausal

Key Exclusion Criteria

  • Individuals who have predominantly non-plaque forms of psoriasis, specifically erythrodermic psoriasis, predominantly pustular psoriasis, medication-induced, or medication-exacerbated psoriasis, or new-onset guttate psoriasis. 
  • Individuals with ongoing inflammatory skin diseases other than psoriasis or any other disease affecting the fingernails, which may potentially confound the evaluation of study treatment. 
  • Individuals with fungal nail infection should be excluded from the study. 
  • Women of childbearing potential who are pregnant, intend to become pregnant (within 6 months of completing the study), or are lactating. 
  • Individuals with any infection or history of recurrent infection requiring treatment with systemic antibiotics within 2 weeks prior to Screening, or severe infection (e.g. pneumonia, cellulitis, bone or joint infections) requiring hospitalization or treatment with intravenous (IV) antibiotics within 6 weeks prior to Screening. 
  • Individuals with any previous use of tildrakizumab or other IL-23/Th-17 pathway inhibitors, including p40, p19 and IL-17 antagonists for psoriasis.
  • Individuals with known history of allergy or hypersensitivity to any of the inactive ingredients of the tildrakizumab or placebo formulations. 

Investigational Plan

The total duration of study participation will be approximately 76 weeks, including a screening period of 28 days, a 52-week treatment period (28-week double-blind placebo-controlled treatment period followed by a 24-week double-blind active treatment period), and a 20-week observational follow-up period. Participants will receive either tildrakizumab or placebo via subcutaneous injection. At Week 28, those who were initially randomized to receive placebo will be switched over to receive tildrakizumab. 

Principal Investigator

A/Prof Peter Foley

For further information, please contact:

Sub Investigator
Dr Ferial Ismail
t: 9623 9464
e: [email protected]

Study Coordinator
Irina Danilovich
t: 9623 9448
e: [email protected]



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Melanoma Research study


Title

Melanoma surveillance photography (MSP)

What is the IMAGE study?

The IMAGE Study (Melanoma surveillance photography to improve early detection of melanoma) tests whether an advanced medical imaging technology called Melanoma Surveillance Photography (MSP), in addition to usual care, helps to improve outcomes compared to usual care alone.

What is MSP?
What is involved in melanoma surveillance photography (MSP)?
MSP combines 2D or 3D total body photography (images of the whole skin surface) with digital dermoscopy (close-up photos of individual skin lesions) to closely monitor lesions and is performed at set intervals – annually in the IMAGE study.

New technology is available that enables rapid, radiation-free total body imaging. These images can be reviewed by your usual doctor to monitor the appearance of skin lesions over time and may help to improve detection of malignant lesions – and to better differentiate malignant from benign lesions.

Eligibility Criteria

Who is eligible to participate?
The IMAGE study is currently recruiting patients with a diagnosis of melanoma within the last 24 months (2 years). Your doctor will be discussing the IMAGE study with you because you have recently been diagnosed with your first melanoma and you may be eligible to participate - if other criteria are also met.

If you are:

  • Aged 18 years or older at date of diagnosis of your first melanoma.
  • Able to provide consent, complete questionnaires, and attend a local study site for MSP.
  • Able to be referred for total body photography (you will need to undress to underwear and stand for imaging)
  • Have “some” or “many” moles; and
  • Currently living in Australia and have no plans to move overseas within the next 3 years.

you may be eligible to participate in the IMAGE study.

There are certain types of melanomas that will mean you are not eligible, even if all criteria above have been met. Your doctor will discuss whether they are relevant for your circumstances. This sheet provides a brief outline of the study but not all information participants will need to consider when thinking about joining the study.

For more detailed information about this study, download the Image Trial Clinicians Information and the Image Trial Patient Referral.


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