Calcipotriol Plus Hydrocortisone in Psoriasis Vulgaris on the Face and on the Intertriginous Areas. A phase 3 study comparing an ointment containing calcipotriol 25 mcg/g plus hydrocortisone 10 mg/g (LEO 80190 ointment) with calcipotriol 25 mcg/g in the ointment vehicle, hydrocortisone 10 mg/g in the ointment vehicle and the ointment vehicle alone, all applied once daily in the treatment of psoriasis vulgaris on the face and on the intertriginous areas, followed by a 52-week safety study in patients with psoriasis vulgaris on the face and on the intertriginous areas.
- Conditions
- Psoriasis vulgaris on the face and on the intertriginous areasThe 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 version: 9.1Level: LLTClassification code 10050576Term: Psoriasis vulgaris
- Registration Number
- EUCTR2007-004782-18-FR
- Lead Sponsor
- EO Pharma A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1225
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.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Systemic treatments with all other therapies than biologicals, with a potential effect on psoriasis vulgaris (e.g., corticosteroids, vitamin D analogues, retinoids, immunosuppressants) within the 4-week period prior to randomisation.
Systemic use of biological treatments, whether marketed or not, directed against or with a potential effect on psoriasis vulgaris (e.g., alefacept, efalizumab, etanercept, iinfliximab, 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 randomisation.
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 randomisation.
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 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 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method