Psoriasis vulgaris MedDRA version: 13.1 Level: LLT Classification code 10050576 Term: Psoriasis vulgaris System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Product Name: LAS41004
Product Code: formulation 1
Pharmaceutical Form: Ointment
INN or Proposed INN: TAZAROTENE
CAS Number: 118292-40-3
Concentration unit: % (W/W) percent weight/weight
Concentration
Sponsors
Almirall Hermal GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •18 to 75 years of age •Caucasian men and women with skin type I to IV (Fitzpatrick 1974) •Suffering from mild to moderate plaque psoriasis of at least 6 months duration that is amenable to local therapy •With at least one stable psoriatic plaque in an area sufficient for product application meeting the following criteria: (1)located at trunk and/or extremities (plaques located on the head, palms, or sole of feet, intertriginous or genitoanal areas are not suitable) (2)Where more than one plaque is to be used, plaques that are comparable, with at least "2" in each score for scaling, erythema and induration. (3)No more than 3 points difference in total score (sum of scores for scaling, erythema and induration) (4)Enough psoriatic plaque surface area for the application to 7 test areas (1.5 x 1.5 cm each) •Prepared to give written informed consent specific to the study, before any assessment may be performed. •Willing to actively participate in the study and to come to scheduled visits •Willing 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) •In the case of women of childbearing potential, using reliable methods of contraception which result in a low failure rate i.e. less than 1% per year (eg contraceptive implants or 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 24 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 24
Exclusion criteria
Exclusion criteria: •Patients who need systemic treatment for their psoriasis •Severe forms of psoriasis or forms of psoriasis other than chronic plaque psoriasis, including: •guttate •erythroderma •exfoliative or •pustular psoriasis, or •psoriatic arthritis •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 •Systemic treatment (see table below): Corticosteroids, antibiotics 4 weeks prior to study day 1 and during conduct of study Retinoids, Ciclosporin, Methotrexate, Fumaric acid esters 3 months prior to study day 1 and during conduct of study Anti-inflammatory substances, NSAIDs 2 weeks prior to study day 1 and during conduct of study Biologics 6 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) 8 weeks before study start and during study •Topical treatment of all other body regions with corticosteroids or immunosuppressants where 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 •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 • Diseases: Skin infections caused by bacteria, viruses or fungi, including but not limited to tuberculosis, syphilis or varicella zoster infection Parasitic infections History of skin reactions after immunization Rosacea, perioral dermatitis in test area Moderate or severe illness within the last two weeks before first exposure Other known infectious diseases (e.g. hepatitis or AIDS) Other 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 • Known calcium metabolism disorders • Vaccination 6 days prior to the study • History of malignancy of any organ system • Severe impairment of liver or kidney function • 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 particip
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Psoriasis will be assessed by ultrasound measurements of skin thickness (distance between the lower border of the entry echo of the skin and the lower border of the dermis as well as the echo lucent band) at study days 1, 8, 15, and 22.;Secondary Objective: a) Efficacy of different treatments will be clinically assessed (visually and by palpating the test area) at study days 8, 15, and 22 compared to baseline b) Ultrasound measurements as changes to baseline (in percent) c) Tolerability of different treatments will be assessed at study days 8, 15, and 22 by a physician d) Assessment of teleangiectasia and erythema at each study visit (safety) e) Digital photography f) Assessment of AEs and SAEs and their relationship to study medication g) Other safety parameters (blood pressure, heart rate, pregnancy test) ;Primary end point(s): AUC of skin thickness at study days 1, 8, 15 and 22.;Timepoint(s) of evaluation of this end point: not applicable | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Skin thickness (distance between lower border of the entry echo of the skin and the lower border of the dermis as well as the width of the echo lucent band) at day 1, 8, 15, and 22 • Percentage change in skin thickness as measured by ultrasound at study day 22 compared to baseline • Percentage change of scaling, erythema and induration score at day 22 compared to baseline • Scaling, erythema and induration score over time (days 1, 8, 15 and 22) • Total score (sum score of scaling, erythema and induration) over time (days 1, 8, 15 and 22) • Descriptive presentation of global tolerability parameters (as assessed by a physician at study days 8, 15, and 22) • Descriptive presentation of safety parameters, i.e. erythema and telangiectasia at all study days • Other safety parameters, i.e. adverse events ;Timepoint(s) of evaluation of this end point: not applicable | — |
Countries
Germany
Contacts
Public ContactDr. Wolf Godehard Ocker
Almirall Hermal GmbH
Outcome results
None listed