A 12 day placebo- and reference-controlled, double-blind, single center, randomized, phase II clinical study with an intraindividual comparison, investigating the anti-psoriatic efficacy and the tolerability of LAS41002 lotion in a psoriasis plaque test - Efficacy and tolerability of LAS41002 lotion in a psoriasis plaque test
- Conditions
- Psoriasis vulgarisMedDRA version: 12.1Level: LLTClassification code 10050576Term: Psoriasis vulgaris
- Registration Number
- EUCTR2009-016629-33-DE
- Lead Sponsor
- Almirall Hermal GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
•18 to 75 years of age
•Caucasian men and women (skin type I to IV, Fitzpatrick 1974)
•Mild to moderate chronic plaque psoriasis
•At least one stable psoriatic plaque (stable plaque = plaque with no major changes in the size and no new plaque formation within the last two weeks prior screening. Changes in scaling and minor changes in erythema are allowed) in an area sufficient for product application
•All patients must give written informed consent before any assessment is performed.
•Psoriasis must be amenable for local therapy
•Willingness to actively participate in the study and come to scheduled visits
•Willingness to discontinue the use of cosmetic products (e.g. soaps, creams, moisturizers) in the treatment area throughout the course of the study
•negative urine pregnancy test (in female patients of child bearing potential)
•Reliable methods of contraception which result in a low failure rate (i.e. less than 1% per year) for women of childbearing potential (implants, injectables, combined oral contraceptives, some intrauterine-devices, sexual abstinence or vasectomized partner)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
•Patients who need systemic treatment for their body psoriasis
•Severe forms of psoriasis and the following forms of psoriasis
•guttatae
•punctata
•erythrodermatica
•exfoliative
•arthropathica
•pustular
•Widespread chronic stationary psoriasis
•Changes in the expression of psoriasis within the last 6 weeks prior screening
•Intensive UV-light exposure within two weeks before the beginning of the test as well as during the study and four weeks after the end of the study at the test area
•Topical treatment of the test area (see table below):
Corticosteroids, antibiotics4 weeks prior to study day 1 and during conduct of study
Retinoids6 weeks prior to study day 1 and during conduct of study
Anti-inflammatory substances2 weeks prior to study day 1 and during conduct of study
Vitamin A analogs,
Vitamin D analogs,
Immunosuppressants,
Anthracen derivates2 weeks prior to study day 1 and during conduct of study
Salicylic acid preparations During conduct of study
Tar2 weeks prior to study day 1 and during conduct of study
UVB therapy2 weeks prior to study day 1 and during conduct of study
PUVA therapy4 weeks prior to study day 1 and during conduct of study
Neutral emollients1 week prior to study day 1 and during conduct of study
•Topical treatment of all other body regions with corticosteroids or immunosuppressants in case more than 20 % of the body surface area is treated
•Treatment with any non-marketed drug substance (i.e. an agent which had not yet been made available for clinical use following registration) within 4 weeks prior to study day 1
•Systemic treatment that may interfere with the investigational product (see table below):
Corticosteroids, antibiotics4 weeks prior to study day 1 and during conduct of study
Retinoids6 weeks prior to study day 1 and during conduct of study
Vitamin D supplements, hydroxycarbamide, azathioprine, meth-otrexate, cyclosporine4 weeks prior to study day 1 and during conduct of study
Immunomodulators3 months prior to study day 1 and during conduct of study
Treatment with biologicals with a possible effect on psoriasis6 months prior study day 1 and during conduct of study
Antiphlogistics
(minor pain relief medicine like acetyl salicylic acid or acetaminophene if not more than 1000 mg per day is allowed)4 weeks prior to study day 1 and during conduct of study
Planned initiation of, or changes to concomitant medication that could affect psoriasis (e.g. beta blockers, anti-malaria drugs, lithium)8 weeks prior to study day 1 and during conduct of study
•Diseases:
Specific skin diseases (such as tuberculosis or syphilis)
Skin infections caused by bacteria or viruses or fungal skin infection
Varicella zoster
Skin reactions after immunization
Rosaceae, perioral dermatitis in test area
Moderate or severe illness within the last two weeks before first exposure
Known infectious diseases (e.g. hepatitis or AIDS)
Other inflammatory skin diseases that may confound the evaluation of psoriasis
•Known hypersensitivity to any of the study drugs, to ingredients of the study drugs, to drugs of similar chemical classes or to plaster
•History of malignancy of any organ system
•Pregnancy or lactation
•Psychiatric conditions that might limit the participation in the trial and/or that lead to the assumption that the ability to completely understand the consequences of consent is missing
•Any history of drug addiction or alcoholism in the past 3 years
•Patients with poor compliance
•Patients, who are i
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method