patients with moderate stable chronic plaque-type psoriasis
Conditions
Interventions
Product Name: LAS 41004
Product Code: LAS 41004
Pharmaceutical Form: Gel
INN or Proposed INN: BEXAROTENE
CAS Number: 153559-49-0
Concentration unit: % percent
Concentration type: equal
Concentration
Sponsors
Almirall Hermal GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •men or women aged 18 years or older; •mild to moderate stable chronic plaque-type psoriasis with at least two symmetrical lesions with a treatment area of 20 – 300 cm² and a TSS of = 6; •the physical examination paying particular attention to the application area must be without further disease findings (other than psoriasis) unless the investigator considers an abnormality to be irrelevant to the outcome of the trial; •female volunteers of childbearing potential* must agree to use for one month prior to start of IMP application, during the trial and for at least one month after EoT reliable methods of contraception with a failure rate of less than 1 % per year (e.g. contraceptive implants of injectables, combined oral contraceptives, some intrauterine devices, sexual abstinence or vasectomized partner). During the trial an additional barrier method (e.g. condoms) must be used. In the case of men with partners of childbearing potential* willingness of using condoms during the study conduct and for 1 month after end of treatment. •written informed consent obtained. * Females NOT of childbearing potential are defined as those who have been surgically sterilized (hysterectomy, bilateral oophorectomy or tubal ligation) or who are postmenopausal (defined as continuous amenorrhea of at least two years) 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 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: •severe forms of psoriasis or forms of psoriasis other than chronic plaque psoriasis, including: -erythrodermic, exfoliative or pustular psoriasis; -psoriatic arthritis; -unstable psoriasis, with a change in severity within the last 6 weeks prior screening; •treatment with any locally acting medications (including anti-psoriatics like vitamin D analogues, dithranol) which might counter or influence the trial aim within 2 weeks preceding the treatment phase of the trial and during the trial; •treatment with any systemic medications which might counter or influence the trial aim (including anti-psoriatics like corticosteroids, cytostatics or medications which are known to provoke or aggravate psoriasis (e.g. ß-blocker, anti-malarial drugs, lithium) or phototherapy/PUVA within 4 weeks preceding the treatment phase of the trial and during the trial; •treatment with vitamin A supplements; •treatment with any biologics within 3 months preceding the treatment phase of the trial and during the trial, or in the case of ustekinumab, within 6 months; •treatment with any immunosuppressive medication within 6 months preceding the treatment phase of the trial and during the trial; •known allergic reactions, irritations or hypersensitivity to the active ingredients (BX, BDP or calcipotriol) or any other ingredient of the IMPs; •contraindications according to summary of product characteristics (SmPC) of the active comparator: -hypersensitivity against the substance or to any of the excipients; -erythrodermic, exfoliative and pustular psoriasis -virus-induced skin lesions (e.g. herpes, varicella) -known calcium metabolism disorders; -viral (e.g. herpes or varicella) lesions of the skin, fungal or bacterial skin infections, parasitic infections; -skin manifestations in relation to tuberculosis or syphilis; -perioral dermatitis; -atrophic skin, striae atrophicae; -fragility of skin veins; -ichthyosis; -acne vulgaris; -rosacea; -ulcers; -wounds; -perianal and genital pruritus. •concomitant use of ketoconazole, itraconazole, erythromycin, grapefruit juice or gemfibrozil or application of products that contain DEET (N,N-diethyl-m-toluamide); •evidence of drug or alcohol abuse; •pregnancy or nursing; •symptoms of a clinically significant illness that may influence the outcome of the trial in the 4 weeks before first treatment and during the trial; •vaccination within the 6 days prior to the trial; •history of malignancy of any organ system (less than 5 years ago); •participation in the treatment phase of another clinical trial within the last 4 weeks prior to the first administration of IMPs in this clinical trial or during the trial; •in the opinion of the investigator or physician performing the initial examination the patient should not participate in the trial, e.g. due to probable noncompliance or inability to understand the trial and give adequately informed consent; •close affiliation with the investigator (e.g. a close relative) or persons working at bioskin GmbH, the other sites or for the sponsor; •patient is institutionalized because of legal or regulatory order.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the anti-psoriatic efficacy and safety of the combination of BX plus BDP in a topical formulation and by reference to Daivobet® ointment (calcipotriol plus BDP).;Secondary Objective: Not applicable;Primary end point(s): The primary variable is the total sign score (TSS) defined as the sum of individual scores for erythema, scaling and infiltration using a 5-point scale (0 = absent, 1 = slight, 2 = moderate, 3 = severe, 4 = severest possible) for each sign clinically assessed (visually and, where relevant, by palpating the test area). The primary endpoint is the change from baseline in the TSS of each treated plaque on Day 29 (EoT). ;Timepoint(s) of evaluation of this end point: Day 29 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Changes from baseline in the TSS on Days 4, 8, 15, and 22 will be evaluated for each treated plaque in a similar way to the primary analysis to assess the onset of treatment effect •Summary statistics will be given for the primary variable TSS and its changes from baseline by treatment and visit for each site. All the following secondary endpoints will be summarized descriptively by treatment: •Changes from baseline in the score for each of the individual signs (erythema, scaling and infiltration) of each treated plaque on Days 4, 8, 15, 22 and 29 •Physician’s global assessment (PGA) score of each treated plaque on Days 1, 4, 8, 15, 22 and 29 ;Timepoint(s) of evaluation of this end point: Days 4, 8, 15, 22 and 29 PGA Days 1, 4, 8, 15, 22, 29 | — |
Countries
Germany
Contacts
Public ContactWiebke Havemeister, PhD
bioskin GmbH
Outcome results
None listed