| 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
The face is defined as: forehead including hairline, cheeks, nose, chin and ears (excluding the auditory meatus). In case of baldness or partial baldness, the forehead should be estimated considering standard or previous hairline.
The intertriginous areas are defined as: 1) the axillae, 2) the genito-femoral and inguinal folds, 3) the inframammary folds, 4) the intergluteal folds and 5) the scrotum. |
|
| 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 |
|
| 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 with calcipotriol 25 mcg/g in
the ointment vehicle, hydrocortisone 10 mg/g in the
ointment vehicle and the ointment vehicle alone in patients
with psoriasis vulgaris on the face. |
|
| 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 with calcipotriol 25 mcg/g in
the ointment vehicle, hydrocortisone 10 mg/g in the
ointment vehicle and the ointment vehicle alone in patientswith 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 with calcipotriol 25 mcg/g in
the ointment vehicle, hydrocortisone 10 mg/g in the
ointment vehicle and the ointment vehicle alone in patients
with psoriasis vulgaris on the face and on the intertrigi-
nous areas.
To evaluate the safety and efficacy of up to 60 weeks
treatment of an ointment containing calcipotriol 25 mcg/g
plus hydrocortisone 10 mg/g in psoriasis vulgaris on the
face and on the intertriginous areas. |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
Following verbal and written information about the trial,
the patient has to provide signed and dated informed
consent before any study related activity is 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 the
limbs, or earlier diagnosed with psoriasis vulgaris on the
trunk and/or the limbs.
An extent of psoriatic involvement of the face of at least
10 cm2 (the sum of all facial lesions).
Treatment areas (the face and the intertriginous areas)
amenable to topical treatment with a maximum of 100 g of
ointment per week.
Disease severity graded as mild, moderate, severe or very
severe according to the investigator’s global assessment of
disease severity of the face.
Age 18 years or above.
Attending hospital outpatient clinic, the private practice of
a dermatologist or the private 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 contraception during the study. |
|
| E.4 | Principal exclusion criteria |
Systemic treatments with all other therapies than biologi-
cals, with a potential effect on psoriasis vulgaris (e.g.,
corticosteroids, vitamin D analogues, retinoids, immuno-
suppressants) within the 4-week period prior to randomi-
sation.
Systemic use of biological treatments, whether marketed
or not, directed against or with a potential effect on
psoriasis vulgaris (e.g., alefacept, efalizumab, etanercept,
infliximab, adalimumab) within 3 months 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 randomisa-
tion.
Topical treatment of the face and the intertriginous areas
within the 2-week period prior to randomisation. (Use of
emollients is allowed on treatment areas during this 2-
week period but not during the double-blind phase of the
study).
Topical treatment with very potent WHO group IV
corticosteroids within the 2-week period prior to randomi-
sation.
Initiation of or changes in concomitant medication that
may affect psoriasis vulgaris (e.g., beta blockers, anti-
malaria drugs, lithium and ACE inhibitors) during the
study.
Current diagnosis of erythrodermic, exfoliative, guttate 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
infections, 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.
Other inflammatory skin diseases (e.g., seborrhoiec
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 double-blind phase.
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 registra-
tion) 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 the trial protocol.
Females who are pregnant, or of child-bearing potential
and wish to become pregnant during the study, or who are
breast feeding. |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
Patients with controlled disease according to the
investigators global assessment of disease severity of the
face at Week 8.
For patients with a baseline (Visit 1) severity of moderate
or worse – “controlled disease” of the face is defined as
clear or almost clear according to the investigator’s
global assessment of disease severity of the face.
For patients with a baseline (Visit 1) severity of mild “controlled disease” of the face is defined as clear according to the investigator’s global assessment of
disease severity of the face. |
|
| 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 | Yes |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | Yes |
| 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 |
| First 8 weeks double blind. Last 52 weeks Open with PR1. |
|
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | No |
| E.8.2.2 | Placebo | Yes |
| 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 | 6 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 77 |
| 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 |
|
| 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
| |
| 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 | 9 |
| E.8.9.1 | In the Member State concerned days | 0 |
| 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 | 9 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
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