E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Psoriasis vulgaris on the face and on the intertriginous areas.
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10050576 |
E.1.2 | Term | Psoriasis vulgaris |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To compare the efficacy of once daily treatment for up to 8 weeks of an ointment containing calcipotriol 25 mcg/g plus hydrocortisone 10 mg/g (LEO 80190 ointment) with an ointment containing hydrocorti-sone 10 mg/g in paediatric patients with psoriasis vulgaris on the face. |
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E.2.2 | Secondary objectives of the trial |
To compare the efficacy of once daily treatment for up to 8 weeks of an ointment containing calcipotriol 25 mcg/g plus hydrocortisone 10 mg/g (LEO 80190 ointment) with an ointment containing hydrocortisone 10 mg/g ointment in paediatric patients with psoriasis vulgaris on the intertriginous areas.
To compare the safety of once daily treatment for up to 8 weeks of an ointment containing calcipotriol 25 mcg/g plus hydrocortisone 10 mg/g (LEO 80190 ointment) with an ointment containing hydrocortisone 10 mg/g ointment in paediatric patients with psoriasis vulgaris on the face and on the intertriginous areas.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Following verbal and written information about the trial, the parent(s)/legal guardian have to provide signed and dated informed consent and the patient must also provide assent, in accordance with regional laws or regulations, before any trial related activi-ties are carried out, including activities relating to the washout period.
Clinical diagnosis of psoriasis vulgaris involving the face.
Clinical signs of psoriasis vulgaris on the trunk and/or on the limbs, or earlier diag-nosed with psoriasis vulgaris on the trunk and/or limbs. The extent and severity of pso-riasis vulgaris on trunk and/or limbs should be amenable to topical therapy with any of the allowed medications (see “concomitant medication”).
An extent of psoriatic involvement of the face of at least 5 cm2 (the sum of all facial lesions).
Treatment areas (the face and the intertriginous areas) amenable to topical treatment with a maximum of 30 g (6 to 11 years) or 45 g (12 to 17 years) of ointment per week.
Disease severity graded as mild, moderate or severe according to the investigator’s global assessment of disease severity of the face.
Aged 6 to 17 years.
Either sex.
Any ethnic origin.
Attending hospital outpatient clinic, the practice of a dermatologist or the practice of a general practitioner experienced in treating psoriasis vulgaris.
Females of childbearing potential must have a negative result for a urine pregnancy test before randomisation.
Females of childbearing potential have to agree to use an adequate method of contra-ception during the study, unless abstinent.
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E.4 | Principal exclusion criteria |
Systemic treatment with therapies other than biologicals with a potential effect on psoriasis vulgaris (e.g., corticosteroids, vitamin D analogues, retinoids, immunosupres-sants) within the 4-week period prior to randomisation.
Systemic treatment with biological therapies (marketed or not marketed) with a possible effect on psoriasis vulgaris within 4 weeks (etanercept), 2 months (adalimu-mab, alefacept, infliximab), 4 months (ustekinumab) or 4 weeks/5 half-lives (which-ever is longer) for experimental biological products prior to randomisation.
PUVA therapy or Grenz ray therapy within the 4-week period prior to randomisation.
UVB therapy within the 2-week period prior to randomisation.
Topical treatment of psoriasis vulgaris lesions on the face or on the intertriginous areas within the 2-week period prior to randomisation (use of emollients is allowed on treat-ment areas during this 2-week period, but not during the study).
Topical treatment with very potent WHO group IV corticosteroids within the 2-week period prior to randomisation.
Initiation of or expected changes to concomitant medication that may affect psoriasis vulgaris (e.g., beta blockers, anti-malaria drugs, lithium and ACE inhibitors) during the treatment phase of the study.
Current diagnosis of erythrodermic, exfoliative or pustular psoriasis.
Patients with any of the following conditions present on the treatment area: viral (e.g., herpes or varicella) lesions of the skin, fungal and bacterial skin infections, parasitic in-fections, skin manifestations in relation to syphilis or tuberculosis, rosacea, perioral dermatitis, acne vulgaris, atrophic skin, striae atrophica, fragility of skin veins, ich-thyosis, acne rosacea, ulcers and wounds.
Other inflammatory skin diseases (e.g., seborrhoeic dermatitis, contact dermatitis and cutaneous mycosis) that may confound the evaluation of psoriasis vulgaris on the face or on the intertriginous areas.
Planned exposure to sun, UVA or UVB that may affect the psoriasis vulgaris during the study.
Known or suspected severe renal insufficiency or severe hepatic disorders.
Known or suspected disorders of calcium metabolism associated with hypercalcaemia.
Known or suspected hypersensitivity to component(s) of the investigational products.
Current participation in any other interventional clinical trial.
Patients 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).
Previously randomised in this study.
Patients known or suspected of not being able to comply with a trial protocol (e.g., due to alcoholism, drug dependency, psychotic state or situations where the patient cannot comply with the protocol due to the parent(s)/legal guardian not being able to fulfil their commitments that contribute to the patient being involved in the study, e.g., em-ployment commitments of parent(s)/legal guardian that prevent them from attending every visit).
Females who are pregnant, or of child-bearing potential and wishing to become pregnant during the study, or who are breast feeding.
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E.5 End points |
E.5.1 | Primary end point(s) |
The percentage change in PASI of the face from baseline to Week 8. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 11 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 7 |