|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
EUCTR |
|
Last refreshed on:
|
19 March 2012 |
|
Main ID: |
EUCTR2009-016629-33-DE |
|
Date of registration:
|
20/11/2009 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
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
|
|
Scientific title:
|
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 |
|
Date of first enrolment:
|
22/12/2009 |
|
Target sample size:
|
|
|
Recruitment status: |
Not Recruiting |
|
URL:
|
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-016629-33 |
|
Study type:
|
Interventional clinical trial of medicinal product |
|
Study design:
|
Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: yes
Other: no
|
|
Phase:
|
|
|
|
Countries of recruitment
|
|
Germany
| | | | | | | |
|
Contacts
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria:
•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
Exclusion criteria:
•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, antibiotics 4 weeks prior to study day 1 and during conduct of study
Retinoids 6 weeks prior to study day 1 and during conduct of study
Anti-inflammatory substances 2 weeks prior to study day 1 and during conduct of study
Vitamin A analogs,
Vitamin D analogs,
Immunosuppressants,
Anthracen derivates 2 weeks prior to study day 1 and during conduct of study
Salicylic acid preparations During conduct of study
Tar 2 weeks prior to study day 1 and during conduct of study
UVB therapy 2 weeks prior to study day 1 and during conduct of study
PUVA therapy 4 weeks prior to study day 1 and during conduct of study
Neutral emollients 1 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, antibiotics 4 weeks prior to study day 1 and during conduct of study
Retinoids 6 weeks prior to study day 1 and during conduct of study
Vitamin D supplements, hydroxycarbamide, azathioprine, meth-otrexate, cyclosporine 4 weeks prior to study day 1 and during conduct of study
Immunomodulators 3 months prior to study day 1 and during conduct of study
Treatment with biologicals with a possible effect on psoriasis 6 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
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
|
|
Health Condition(s) or Problem(s) studied
|
Psoriasis vulgaris
MedDRA version: 12.1
Level: LLT
Classification code 10050576
Term: Psoriasis vulgaris
|
|
Intervention(s)
|
Product Name: LAS41002 lotion
Product Code: LAS41002 lotion
Pharmaceutical Form: Cutaneous emulsion
CAS Number: 83919-23-7
Other descriptive name: MOMETASONE FUROATE
Concentration unit: % (W/W) percent weight/weight
Concentration type: equal
Concentration number: 0.1-
Pharmaceutical form of the placebo: Cutaneous emulsion
Route of administration of the placebo: Cutaneous use
Trade Name: ECURAL Fettcreme
Pharmaceutical Form: Cream
CAS Number: 83919-23-7
Other descriptive name: MOMETASONE FUROATE
Concentration unit: % (W/W) percent weight/weight
Concentration type: equal
Concentration number: 0.1-
|
|
Primary Outcome(s)
|
Secondary Objective: The secondary objectives are:
•Clinical examination (visually and by palpating the respective test area) at study day 5, LAS41002 lotion compared to placebo.
•Clinical examination (visually and by palpating the respective test area) at study days 5 and 12, LAS41002 lotion compared to the reference product Ecural® cream (non-inferiority)
•Relative changes (given in %) from baseline ultrasound measurements at study day 5 and study day 12: LAS41002 lotion in comparison to placebo and the reference product Ecural® cream
•Global tolerability of LAS41002 lotion, reference and placebo, assessed at the last study day
•Clinical (digital) photography at each assessment time point
•Safety parameters are documented and analyzed during treatment
|
|
Main Objective: The primary objective of this study is the clinical examination (visually and by palpating the respective test area) of the reduction of psoriatic lesions: LAS41002 lotion better than (superior to) placebo at study day 12.
|
|
Primary end point(s): Analysis of superiority of the test product LAS41002 to placebo with respect to clinical examinations (visually and by palpating the respective test area) at study day 12
|
|
Secondary ID(s)
|
|
H521000-0914
|
|
Source(s) of Monetary Support
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|