Randomized, observer-blind, multi-center, reference-controlled phase IIb study to evaluate the efficacy of topically applied LAS41002 lotion in the treatment of scalp psoriasis - Efficacy of LAS41002 lotion in the treatment of scalp psoriasis

Conditions: Psoriasis vulgaris on the scalp
MedDRA version: 12.0Level: LLTClassification code 10037157Term: Psoriasis of scalp
MedDRA version: 12.0Level: LLTClassification code 10050576Term: Psoriasis vulgaris

Registration Number: EUCTR2009-016261-28-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

Inclusion Criteria

•Male or female patients 18-75 years of age
•Chronic scalp psoriasis for at least 4 months before enrollment in this study
oTSS = 4 (at least one sign graded with 2, on each other sign a grade of 1 is required) up to 12
oExtent of scalp psoriasis involving more than 10 % of the total scalp area
•All patients must give written informed consent before any assessment is performed.
•General good health as determined by investigator based upon results of medical history
•Scalp psoriasis is amenable for topical treamtent
•Willingness to actively participate in the study and come to scheduled visits
•Willingness to discontinue the use of their own topical psoriasis treatment at the scalp
•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

Exclusion Criteria

•Patients who need systemic treatment for their body psoriasis
•History of hypersensitivity to any of the study drugs or ingredients of the study drugs or to drugs of similar chemical classes
•History of malignancy of any organ system
•Atrophy of the scalp
•Medication:
•Systemic treatment that may interfere with the investigational product
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 scalp psoriasis6 months 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)

-Topical treatment of, scalp, face and neck (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 analogues, Vitamin D analogues, Immunosuppressants, Anthracen derivates 2 weeks prior to study day 1 and during conduct of study
Salicylic acid preparations2 weeks prior to study day 1 and 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 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
•Planned use of chemical treatments of the hair (e.g. relaxers, perms or colorings) during the conduct of the study
•Shampoos containing corticosteroids within 2 weeks before study day 1 and during the conduct of the study
•Diseases:
Specific skin diseases (such as tuberculosis or syphilis)
Erythrodermic, exfoliative or pustular psoriasis
Skin infections caused by bacteria or viruses or fungal skin infection
Varicella zoster
Skin reactions after immunization
Rosaceae, perioral dermatitis
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
•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 inmates of psychiatric wards, prison or state institutions
•Participation in a clinical trial within the last 30 days prior to the start of this study
•Patients underlying any other restrictions due to the participation in other tests / test institutes
•Employees of the study sites or of the Sponsor’s company
•If in the opinion of the investigator the patient should not particip