Psoriasis vulgaris MedDRA version: 18.0 Level: PT Classification code 10037153 Term: Psoriasis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Product Name: LEO 90100 aerosol foam
Pharmaceutical Form: Cutaneous foam
INN or Proposed INN: CALCIPOTRIOL HYDRATE
CAS Number: 147657-22-5
Other descriptive name: CALCIPOTRIOL MONOHYDRATE
Concentratio
Sponsors
LEO Pharma A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Signed and dated informed consent has been obtained. 2. Subjects with a diagnosis of psoriasis vulgaris with preferably three lesions (plaques) located on arms, legs and/or trunk or at least two lesions (plaques) located on arms, legs and/or trunk. For subjects with three lesions, each leasion must have a size suitable to accommodate 2 test sites (test site area 5 cm2, distance between two test sites at least 2 cm). For subjects with two lesions, one lesion must have a size suitable to accommodate 4 test sites, and the other lesion must accommodate 2 test sites. 3. Age 18 years or above. 4. Outpatients. 5. Subjects with, in the opinion of the investigator, stable psoriasis based on Total Plaque Score evaluated at screening visit and rechecked at visit 2 (Baseline). The score of each clinical sign (erythema, scaling, infiltration) must not change more than one point between the 2 visits. 6. Subjects with psoriasis lesions (plaques) assessed by a Total Plaque Score (sum of scores of erythema, scaling and infiltration) of 4 to 9 (both included) but each individual item should have a score of = 1. 7. Subjects willing and able to follow all the trial procedures and complete the whole trial. 8. Subjects affiliated to a social security system. 9. Female subjects with a negative urine pregnancy test (at screening visit and Day 1). 10. Female subjects must be of either - non-childbearing potential, i.e. post-menopausal or have a confirmed clinical history of sterility (e.g. the subject is without a uterus or has tubal ligation) or, - child-bearing potential* provided there is a confirmed negative pregnancy test prior to trial treatment to rule out pregnancy. * Female subjects are considered of child-bearing potential unless they have had a hysterectomy or have undergone tubal ligation or have been post-menopausal for at least one year prior to first visit. 11. Female subjects of child-bearing potential must be willing to use effective contraception** at trial entry until completion. ** Effective contraception is defined as follows: - Abstinence (when this is in line with the preferred and usual life style of the subject). - Vasectomised partner (given that the subject is monogamous). - An intrauterine device. - Double barrier method defined as two distinct methods (two actual barrier methods). - Hormonal contraceptive (oral hormonal birth control, oestrogenic vaginal ring, percutaneous contraceptive patches, implants and injectables) for at least one menstrual cycle prior to enrolment. - Condoms (since a systemic effect is highly improbable related to the very low doses on small test sites). 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 5
Exclusion criteria
Exclusion criteria: 1. Female subjects who are breast feeding. 2. Systemic treatment with biological therapies, whether marketed or not, with a possible effect on psoriasis vulgaris within the following time periods prior to randomisation: - Etanercept - within 4 weeks prior to randomisation and during the trial, - Adalimumab, infliximab - within 8 weeks prior to randomisation and during the trial, - Ustekinumab - within 16 weeks prior to randomisation and during the trial, - Other products - within 4 weeks/5 half-lives prior to randomisation and during the trial (whichever is longer). 3. Systemic treatment with all other therapies than biologicals, with a potential effect on psoriasis vulgaris (e.g., corticosteroids, retinoids, immunosuppressants) within the 4- week period prior to randomisation and during the trial. 4. Subjects using phototherapy within the following time periods prior to randomization and during the trial: - PUVA: 4 weeks - UVB: 2 weeks 5. Subjects using one of the following topical drugs for the treatment of psoriasis within the 4 week period prior to randomisation and during the trial: - Potent or very potent (WHO group III-IV) corticosteroids. 6. Subjects using one of the following topical drugs for the treatment of psoriasis within 2 weeks prior to randomisation and during the trial: - WHO group I-II corticosteroids (except if used for treatment of scalp and/or facial psoriasis), - Topical retinoids, Vitamin D analogues, Topical immunomodulators (e.g. calcineurin inhibitors), Tar products, Salicylic acid. 7. Subjects using emollients on the selected plaques within 1 week before randomization and during the trial. 8. Initiation of, or expected changes to concomitant medication that may affect psoriasis vulgaris (e.g., beta blockers, antimalarial drugs, lithium and ACE inhibitors) within 2 weeks prior to the randomisation and during the trial. 9. Subjects with current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis. 10. Subjects with known/suspected disorders of calcium metabolism associated with hypercalcemia within the last 10 years, based on medical history and/or subject interview. 11. Subjects with any of the following conditions present on the test areas: viral (e.g. herpes or varicella) lesions of the skin, fungal and bacterial skin infections, parasitic infections and atrophic skin. 12. Subjects with skin manifestations in relation to syphilis or tuberculosis, rosacea, perioral dermatitis, acne vulgaris, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, acne rosacea, ulcers and wounds within the selected plaques. 13. History of any severe disease or serious current condition (based on subject interview and/or results of screening physical examination) which, in the opinion of the Investigator, would put the subject at risk by participating in the trial or would interfere significantly with the evaluation of trial results or the trial course (e.g. cancer, severe uncontrolled cardiopathy, severe renal insufficiency, severe hepatic insufficiency). 14. Subjects who have received treatment with any non-marketed drug substance (i.e., an agent which has not yet been made available for clinical use following registration) within the 4 week period prior to randomisation or longer, if the class of the substance requires a longer washout as defined above (e.g., biological treatments). 15. Subjects with current participation in any other interventional clinical trial, ba
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the anti-psoriatic effect of LEO 90100 aerosol foam compared with Betesil® medicated plaster.;Secondary Objective: To evaluate the local tolerability of LEO 90100 aerosol foam compared with Betesil® medicated plaster.;Primary end point(s): Absolute change in Total Clinical Score (TCS) of clinical signs (sum of erythema, scaling and infiltration) at end of treatment compared to baseline.;Timepoint(s) of evaluation of this end point: Day 1 and Day 29 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Clinical criteria: - Absolute change in score of each clinical sign: erythema, scaling, infiltration at end of treatment and at individual visits compared to baseline. - Absolute Change in Total Clinical Score (TCS) at individual visits compared to baseline. Ultrasound measurements: - Absolute change in total skin thickness and echo-poor band thickness at end of treatment compared to baseline.;Timepoint(s) of evaluation of this end point: - Single clinical sign score and Total Clinical Score will be evaluated at Day 1, Day 4, Day 8, Day 11, Day 15, Day 18, Day 22, Day 25 and Day 29. - Total skin thickness and echo-poor band thickness will be evaluated at Day 1 and Day 29. | — |
Countries
France
Contacts
Public ContactFlorence Préaud
LEO Pharma
Outcome results
None listed