Plaque-type psoriasis (psoriasis vulgaris) for at least 6 months MedDRA version: 12.1 Level: LLT Classification code 10050576 Term: Psoriasis vulgaris
Conditions
Interventions
Product Code: H 553 000 / 063
Pharmaceutical Form: Ointment
INN or Proposed INN: Betamethasone dipropionate
CAS Number: 5593-20-4
Concentration unit: g gram(s)
Concentration type: equal
Concentration
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 6 month • Psoriasis plaques that are suitable to be defined as target area lesions by the following criteria: o Psoriasis plaques must be located at 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 psoriasis plaques with at least “2” in each score (Range 0-4) for the three distinct symptoms 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 psoriasis plaques o Enough psoriatic surface area to define 8 clearly distinguishable (minimum distance between test areas: 1 cm) test areas of at least 1 cm² plaque size • Patient is willing and able to comply with the requirements of the clinical study protocol. In particular, patient must adhere to concomitant therapy prohibitions of the test areas and must agree 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 contraceptive methods for the duration of the study and the following 4 weeks after the end of study: o Strict abstinence (exception: male partner with a vasectomy for at least 3 months prior to study entry is allowed) o Combined oral, implanted or injectable contraceptives on a stable dose for at least 3 months prior to study entrance o Intrauterine device (IUD) inserted for at least 1 month prior to study entrance 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
Exclusion criteria: • Too few body surface area covered with psoriasis plaques that meet the specified inclusion criteria to be defined as 8 clearly distinguishable test areas • Any condition that may interfere with the study assessments or sonographic measurements of the skin and/or may have an influence on skin immune response (incl. open wounds) • Known adverse reactions of any severity or hypersensitivity to any ingredient of the test products • No willingness to avoid induction of heavy sweating, e.g. due to sauna visits, excessive sports activities during the study course • No willingness 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 trial (including but not limited to: infectious diseases, major surgery within the last 4 weeks, coronary artery disease, renal impairment, hepatic impairment, uncontrolled metabolic diseases, disorders of the calcium metabolism, autoimmune diseases) • Significant skin diseases other than plaque-type psoriasis, incl. skin infections • History or presence of malignant disease (other than surgically removed basal cell carcinoma) and/or auto immune diseases • Current diagnosis of guttate, erythrodermic or pustular psoriasis •Patients who did not respect the following wash-out periods prior or during the study: Treatment Wash out period Topical treatment in the test area Any topical anti-psoriatic drug 2 weeks Systemic treatment Biologics 6 months Any other systemic treatment (corticosteroids, ciclosporin, MTX, fumaric acid esters) 3 months Procedures Phototherapy 4 weeks • 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 • Vaccination 6 days prior to enrolment or during the study • Subjects 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 trial • Participation in any other clinical trial within 30 days prior or during this trial • Subject is an adult under guardianship, hospitalised, deprived of freedom or unable to communicate or cooperate with the investigator due to language or mental problems
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective is to gain evidence of the efficacy of five distinct combinations of Betamethason dipropionate and Tazaroten in different concentrations compared to Placebo, Zorac®-gel and Daivobet®-ointment in the treatment of Plaque-Type Psoriasis assessed by the AUC of the width of the echo-lucent band located at the dermo-epidermal junction as measured by sonography at visit 1, 4, 8 and 11.;Secondary Objective: Secondary objective is to evaluate the efficacy assessed by means of the following symptoms: scaling, erythema and induration of the test areas. In addition, a total score (sum score of these three symptoms) is evaluated. All scores are analyzed by displaying the development during the study over time and by the percentage of change at visit 11 compared to baseline. Further secondary endpoints are the development and the percentage change of the width of the echolucent band over time, the tolerability of the formulations as measured by a physicians’ assessment of tolerability at visit 4, 8 and at the end of the study, the erythema and telangiectasia scores at visit 2 to 10 and to evaluate the safety as assessed by incidence and severity of AEs and SAEs and their relationship to the study medications. ;Primary end point(s): In the present exploratory study no sample size calculation has been performed. The sample size has been determined from the clinician’s perspective. The number of 20 evaluable subjects (recruitment of 22 subjects) is based on the clinical assumption of how many subjects are needed to gain first evidence of efficacy and safety of the IMPs. The primary endpoint is the AUC of 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 sonography at visit 1, 4, 8 and 11. | — |
Countries
Germany
Outcome results
None listed