Plaque psoriasis is a common skin condition where patches (plaques) develop which are thick, red and scaly and they may sometimes itch. The plaques are often located on the knees, elbows and back, but they may be found on all parts of the body.
There is currently no cure for psoriasis, but there are several treatments available which reduce the signs and symptoms of the condition. Topical treatment, which is one that is applied directly to the skin, is one type of treatment for psoriasis. LEO 90100 aerosol foam (“LEO 90100”) is a new topical treatment for psoriasis. LEO 90100 showed good clinical efficacy (meaning it worked well to treat the symptoms of psoriasis) in short term clinical trials of 4-week and 12-week duration. These trials also showed LEO 90100 was safe to use. However, psoriasis is a life-long disease for most patients and this trial is being conducted because there is a need for a safe long-term treatment strategy for psoriasis.
It is well known that when psoriasis treatment is discontinued, lesions will come back. Some studies suggest that continued use of topical medication at a low dose after plaques have cleared may delay the time to reappearance of plaques. Such treatment is called maintenance treatment. The goal of maintenance treatment is to retain the initial improvement for as long as possible while minimizing the side effects. The purpose of this 1 year trial is to test if LEO 90100 is effective and safe to use as a maintenance treatment for psoriasis on the body.
Is this trial right for me?
If you have been diagnosed with a condition known as plaque psoriasis on the body you may be eligible to participate in this trial.
Am I eligible for this trial?
The investigator ensures that potential participants wanting to volunteer are eligible to take part based on the criteria detailed in the clinical trial protocol. This involves reviewing your full medical history, performing a medical examination, obtaining a signed informed consent and obtaining blood sample(s).
You may be eligible to participate in this trial, if you fulfill the following inclusion criteria and none of the exclusion criteria:
- • Male or female
- • Age 18 years or above
- • A clinical diagnosis of psoriasis vulgaris for at least 6 months involving the trunk and/or limbs
- • Psoriasis vulgaris on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) involving 2-30% of the body surface area (BSA)
- • Systemic treatment with biological therapies, whether marketed or not, with a possible effect on psoriasis vulgaris during or prior to trial participation (product-specific timelines apply)
- • Systemic treatment with all other therapies with a possible effect on psoriasis vulgaris (e.g. corticosteroids, retinoids, methotrexate, ciclosporin and other immunosuppressants within 4 weeks prior to Visit 1)
- • Systemic treatment with apremilast within 4 weeks prior to Visit 1
- • Psoralen combined with Ultraviolet A (PUVA) therapy within 4 weeks prior to Visit 1
- • Ultraviolet B (UVB) therapy within 2 weeks prior to Visit 1
- • Severe and/or extensive scalp psoriasis which, in the opinion of the investigator, requires treatment with potent or super-potent corticosteroids which will be prohibited during the trial.
What will happen during this trial?
You will first be screened by a medical doctor to determine your eligibility for this trial. If you are eligible and agree to participate, you will first receive 4 weeks of once daily treatment with LEO 90100. If your psoriasis by the end of this 4 week period has cleared, you may qualify for the second part of the trial: You will then be randomly placed (like the flip of a coin) into one of two treatment groups (“maintenance treatment”). One group will receive LEO 90100 (active medication) and one group will receive placebo, which looks like LEO 90100, but contains no active ingredients. Both groups will apply the maintenance treatment twice weekly for 52 weeks.
If you experience a worsening of your psoriasis, your maintenance treatment will temporarily be switched to once daily treatment with LEO 90100 for up to 4 weeks until your psoriasis lesions have disappeared. Then you will resume twice weekly maintenance treatment.
The trial will include at least 20 visits to the trial clinic. Your participation could last up to 60 weeks, including the possibility of up to 4 weeks of follow-up after you have stopped using maintenance treatment.
In order to prevent any opinions anyone may have about LEO 90100 or placebo from affecting the results of the trial, neither you, the doctors, or the trial staff will know the trial treatment group assignments.
During the trial visits, you will be asked to give personal information, such as your date of birth, gender, race, ethnicity, and you will also be asked questions about your general health, your medical history and any medications you take.
The trial doctor will perform a physical examination that includes a dermatologic examination of your skin. In particular, the trial doctor will assess the severity of your psoriasis at each visit. During the trial, blood and urine samples will be taken. Pregnancy tests will be performed monthly if you are a female of childbearing potential. At the site visits you will have to answer some questionnaires on an electronic slate regarding health-related quality of life and the ability to work and perform regular activities. Furthermore, questions about severity of psoriasis symptoms and compliance with the treatment regimen must be completed on an electronic device provided to the participant to take home for the duration of the trial.GET PDF