| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
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| E.1.1.1 | Medical condition in easily understood language |
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| E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 18.0 |
| E.1.2 | Level | PT |
| E.1.2 | Classification code | 10037153 |
| E.1.2 | Term | Psoriasis |
| E.1.2 | System Organ Class | 10040785 - Skin and subcutaneous tissue disorders |
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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 evaluate the anti-psoriatic effect of LP0113 aerosol spray compared to Daivobet® gel, LEO 90100 aerosol foam, betamethasone dipropionate in the aerosol spray vehicle, calcipotriol in the aerosol spray vehicle and aerosol spray vehicle. |
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| E.2.2 | Secondary objectives of the trial |
| To obtain information on local tolerability of LP0113 aerosol spray compared to Daivobet® gel, LEO 90100 aerosol foam, betamethasone dipropionate in the aerosol spray vehicle, calcipotriol in the aerosol spray vehicle and aerosol spray vehicle. |
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| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
- Signed and dated informed consent has been obtained
- Subjects with a diagnosis of psoriasis vulgaris with lesions located on arms, legs and/or trunk. The lesions must have a total size suitable for application of 6 different products.
- Age 18 years or above
- Outpatients
- 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)
- Subjects with psoriasis lesions (plaques) assessed by a Total Clinical Score (sum of scores of erythema, scaling and infiltration) of 4 to 9 inclusive but each individual item ≥ 1
- Subjects willing and able to follow all the trial procedures and complete the whole trial
- Subjects affiliated to a social security system
- Female subjects with a negative urine pregnancy test (at screening visit).
- 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.
- 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).
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| E.4 | Principal exclusion criteria |
- Female subjects who are breast feeding
- 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)
- 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
- Subjects using phototherapy within the following time periods prior to randomisation and during the trial: PUVA: 4 weeks, UVB: 2 weeks
- 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
- 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
- Subjects using emollients on the selected plaques within 1 week before randomisation and during the trial
- 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
- Subjects with current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis
- Subjects with known/suspected disorders of calcium metabolism associated with hypercalcemia within the last 10 years, based on medical history and/or subject interview
- 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
- Subjects with skin manifestations in relation to syphilis or tuberculosis, rosacea, pe¬rioral dermatitis, acne vulgaris, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, acne rosacea, ulcers and wounds within the selected plaques
- 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)
- 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)
- Subjects with current participation in any other interventional clinical trial, based on interview of the subject
- Subjects with known or suspected hypersensitivity to component(s) of the investigational products
- Subjects with any concomitant medical or dermatological disorder(s) which might preclude accurate evaluation of the psoriasis on the test areas
- Subjects foreseeing an intensive solar exposure during the trial (UV radiation, etc.) or having been exposed within 2 weeks preceding the screening visit
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| E.5 End points |
| E.5.1 | 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. |
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| E.5.1.1 | Timepoint(s) of evaluation of this end point |
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| E.5.2 | Secondary end point(s) |
Clinical criteria:
- Absolute change in single clinical sign score: erythema, scaling, infiltration at end of treatment and 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.
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| E.5.2.1 | Timepoint(s) of evaluation of this end point |
- Single clinical symptom 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.
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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 | No |
| 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) | Yes |
| E.7.3 | Therapeutic confirmatory (Phase III) | No |
| 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 | Yes |
| E.8.1.4 | Double blind | No |
| E.8.1.5 | Parallel group | No |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | Yes |
| E.8.1.7.1 | Other trial design description |
| Within-subject comparison |
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| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | Yes |
| E.8.2.2 | Placebo | Yes |
| E.8.2.3 | Other | No |
| E.8.2.4 | Number of treatment arms in the trial | 6 |
| E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
| E.8.4 | The trial involves multiple sites in the Member State concerned | No |
| E.8.5 | The trial involves multiple Member States | No |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | No |
| E.8.6.2 | Trial being conducted completely outside of the EEA | No |
| E.8.7 | Trial has a data monitoring committee | No |
| 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 | 0 |
| E.8.9.1 | In the Member State concerned months | 4 |
| E.8.9.1 | In the Member State concerned days | 0 |
| E.8.9.2 | In all countries concerned by the trial years | 0 |
| E.8.9.2 | In all countries concerned by the trial months | 4 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
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