Plaque-type psoriasis (psoriasis vulgaris) for at least 12 months 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: LAS 41004 (Steroid & Retinoid)
Product Code: H 553 000 / 089
Pharmaceutical Form: Ointment
INN or Proposed INN: Betamethasone dipropionate
CAS Number: 5593-20-4
Concentration unit: % (W/
Sponsors
Almirall Hermal GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Male or female patients between 18 and 75 years of age with a diagnosis of stable plaque-type psoriasis (psoriasis vulgaris) for at least 12 months Psoriatic plaques that are suitable to be defined as target area lesions by the following criteria: o Psoriatic plaques must be located on the trunk and/or extremities. Plaques that are located on the head (incl. scalp), palms, sole of the feet, intertriginous or genitoanal areas are not suitable as target areas o Comparable psoriatic plaques with at least “2” in each score (range 0-4) for the three distinct signs: scaling, erythema and induration o No more than 3 points difference in total score (= sum of scores for scaling, erythema and induration Range 0-12) of the chosen comparable psoriatic plaques o Enough surface area to the psoriatic plaque to define eight clearly distinguishable (minimum distance between test areas: 1cm) test areas of at least 1 cm² size -Patient is willing and able to comply with the requirements of the clinical study protocol. In particular, patient must agree not to use prohibited concomitant therapy in the test areas and to avoid intense UV exposure of the test areas during the study -Written informed consent to participate in the study, prior to any study related procedures, indicating an understanding of the purpose of the study -A patient of childbearing potential agrees to use one of the following highly effective contraceptive methods for the duration of the study and for the 4 weeks after study drug discontinuation: o Combined oral, implanted or injectable contraceptives on a stable dose for at least 3 months prior to study entrance, OR o Partner who has been sterilized by vasectomy for at least 3 months prior to study entry, OR o Intrauterine devices (IUD) inserted for at least 4 weeks prior to study entrance, AND o Barrier methods (e.g. condom, cervical caps, diaphragm) Note: The investigator must inform all female patients of childbearing potential that bexarotene can potentially induce metabolic enzymes and thereby theoretically reduce the efficacy of oestroprogestative contraceptives. -Male patients with sexual partners who are pregnant, possibly pregnant, or who could become pregnant must use condoms during sexual intercourse for the duration of the study and for at least 4 weeks after the last dose of drug. 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 22 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 22
Exclusion criteria
Exclusion criteria: -Too small a body surface area covered with psoriatic plaques that meet the specified inclusion criteria -Any condition that may interfere with the study assessments or ultrasound measurements of the skin and/or may have an influence on the skin immune response (incl. open wounds) -Known adverse reactions of any severity or hypersensitivity to any ingredient of the test products or other retinoid -Not willing to avoid induction of heavy sweating, e.g. due to sauna visits, excessive sports activities during the study course -Not willing to avoid swimming, bathing or wetting of the designated test areas between visits -Pregnant or breast-feeding women -A medical condition that may put the patient at a general risk and therefore would prevent participation in the clinical study (including but not limited to: serious infectious diseases, major surgery within the last 4 weeks, or significant coronary artery disease, renal impairment, hepatic impairment, uncontrolled metabolic diseases, disorders of calcium metabolism, or autoimmune diseases) -History or presence of malignant disease (other than surgically removed basal cell carcinoma) - Current diagnosis of guttate, erythrodermic or pustular psoriasis -Patients who did not respect the following wash-out periods prior to study entry or do not restrain from using one of the following treatments during the study: Treatment Wash out period Topical treatment in the test area: Any topical anti-psoriatic drug: 2 weeks Products containing DEET (N,N-diethyl-m-polyamide), a common component of insect repellent products: 1 week Systemic treatment Biologics: 6 months Any other systemic antipsoriatic treatment (corticosteroids, ciclosporin, methotrexate, fumaric acid esters, acitretin etc): 3 months Procedures Phototherapy or artificial ultraviolet light via sunbeds: 4 weeks -Significant skin diseases other than plaque-type psoriasis (psoriasis vulgaris), including but not limited to: skin disease due to tuberculosis or syphilis, rosacea, perioral dermatitis, acne vulgaris, skin atrophy, striae distensae, increased fragility of skin blood vessels, ichthyosis, ulcers, wounds and reaction after vaccination -Significant skin infections (including but not limited to: herpes, varicella, mycotic skin infections (except for tinea pedis), bacterial skin infections or parasitic skin infections) -Excessive sunlight exposure within 28 days prior to study entry and during the conduct of the study -Usage of any topical formulation (incl. cosmetics, emollients, etc) on the designated target areas during the course of the study -Vitamin A intake > 15,000 IU/day Vaccination 6 days prior to enrolment or during the study -Patients who are – in the opinion of the investigator – unreliable, and/or non-compliant, and/or who present with any condition or treatment (including cosmetic products) that may interfere with psoriasis or the conduct of the study -Participation in any other clinical study within 30 days prior or during this study -Patient is an adult under guardianship, hospitalized, deprived of freedom or unable to communicate or cooperate with the investigator due to language or mental problems
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The primary endpoint is the AUC of the width of the echo-lucent band located at the dermo-epidermal junction (representing the combination of acanthotic epidermal thickening and inflammation in psoriasis) as measured by ultrasound at visits 1, 4, 8 and 11.;Timepoint(s) of evaluation of this end point: at visits 1, 4, 8 and 11.;Main Objective: The objective of the study is to gain an indication of efficacy for five distinct combinations of bexarotene and betamethasone dipropionate in different concentrations, and one combination of tazarotene and betamethasone dipropionate compared to bland ointment (Vaseline®) and Daivobet® -ointment in the treatment of Plaque-Type Psoriasis. This is accomplished by comparison of the treatment areas over time as assessed by the area under the curve of the width of the echo-lucent band located at the dermo-epidermal junction, as measured by ultrasound at visits 1, 4, 8 and 11, as the primary endpoint.;Secondary Objective: Secondary efficacy endpoints comprise: the percentage change of a score for scaling, for erythema and for induration in the treated area, as well as a total score (sum of the scores of these three distinct signs) and the development of the scores over time; the absolute and the percentage change from baseline over time of the width of the echo-lucent band. Safety and tolerability will be assessed by the physicians? assessment of tolerability for each formulation, and in addition by evaluation of adverse events and serious adverse events. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints are: Width of the echo-lucent band locatedat the dermo-epidermal junction at visits 1, 4, 8 and 11 Percentage change in width of the echo-lucent band located at the dermoepidermal junction as measured by ultrasound at visit 11 compared to baseline Percentage change of total score comprising the sum of scores of scaling, erythema and induration at visit 11 compared to baseline Percentage change of scaling score at visit 11 compared to baseline Percentage change of erythema score at visit 11 compared to baseline Percentage change of induration score at visit 11 compared to baseline Total score representing the sum of scores of scaling, erythema and induration) over time (visits 1, 4, 8, and 11) Scaling score over time (visits 1, 4, 8 and 11) Erythema score over time (visits 1, 4, 8 and 11) Induration score over time (visits 1, 4, 8 and 11) Physicians’ assessment of tolerability at visits 4, 8 and 11 Telangiectasia score at visits 2 to 10 Irritation score at visits 2 to 10 Adverse Events ;Timepoint(s) of evaluation of this end point: Width of the echo-lucent band locatedat the dermo-epidermal junction at visits 1, 4, 8 and 11 Physicians’ assessment of tolerability at visits 4, 8 and 11 Telangiectasia score at visits 2 to 10 Irritation score at visits 2 to 10 Adverse Events visits 1 to 11 | — |
Countries
Germany
Contacts
Public ContactDr. Godehard Ocker
Almirall Hermal GmbH
Outcome results
None listed