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. 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: 9.1 Level: LLT Classi
Conditions
Interventions
Product Name: calcipotriol 25 mcg/g plus hydrocortisone 10 mg/g
Product Code: LEO 80190 ointment
Pharmaceutical Form: Ointment
INN or Proposed INN: calcipotriol
CAS Number: 147657-22-5
Concentration u
Sponsors
LEO Pharma A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Signed informed consent has been obtained. Clinical diagnosis of psoriasis vulgaris involving the face and the intertriginous areas. 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 the psoriatic involvement on the face of at least 10 cm² (the sum of all facial lesions) and on the intertriginous areas of at least 20 cm² (the sum of all intertriginous areas) at the Baseline Visit and Visit 1. Treatment areas (the face and the intertriginous areas) amenable to topical treatment with a maximum of 100 g of study medication per week. Disease severity of the face and of the intertriginous areas graded as moderate, severe or very severe according to the investigator’s global assessment of disease severity at the Baseline Visit and Visit 1. Patients with a normal HPA axis function at the Baseline Visit including: •serum cortisol concentration above 5 mcg/dl before ACTH (tetracosactid) injection, •serum cortisol concentration above 18 mcg/dl 30 minutes after ACTH (tetracosactid) stimulation. Albumin corrected serum calcium at the Baseline Visit within the reference range. Age 18 years or above. Either sex. Any race and ethnic origin. Females of childbearing potential must have a negative result of a pregnancy test performed at the Screening Visit and at the Baseline Visit. Female subjects of child bearing potential have to agree to use a highly effective method of birth control with a failure rate of less than 1% for the clinical study; acceptable are double barrier methods (e.g. cervical cap plus male condom), intra-uterine devices (IUD), surgical sterilization (e.g. documented hysterectomy or tubal ligation), abstinence from intercourse (beginning latest 2 weeks prior to first application of IMP), male sexual partner is sterilized (at least 3 months prior to first application of IMP) and hormonal contraception based on progestin-only formulations (injectables or implants only). Lactating women and use of hormonal contraception on estrogen-basis are not allowed. Able to communicate well with the investigator, to understand and comply with the requirements of 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
Exclusion criteria
Exclusion criteria: A history of active allergy (except for pollinosis), asthma, allergic skin rash, or sensitivity to any medication (including ACTH, tetracosactid) or to any component of the formulations being tested. Systemic treatment with all other therapies than biologicals, with a potential effect on psoriasis vulgaris (e.g., vitamin D analogues, retinoids, immunosuppressants) within 2 weeks prior to Visit 1. Systemic treatment with corticosteroids (including inhaled) within 12 weeks prior to Visit 1. 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 12 weeks prior to Visit 1. PUVA therapy or Grenz ray therapy within 4 weeks prior to Visit 1. UVB therapy within 2 weeks prior to Visit 1. Topical treatment of the face, trunk/limbs or the scalp with topical WHO group 2, 3 and 4 corticosteroids within 4 weeks prior to Visit 1. Topical treatment of the face, trunk/limbs or the scalp with topical WHO group 1 corticosteroids within 2 weeks prior to Visit 1. Any topical treatment of the face or the intertriginous areas (except for emollients) within 2 weeks prior to Visit 1. Unwilling to avoid treatment for the duration of the study with topical corticosteroids. Initiation of or expected changes in concomitant medication that could affect psoriasis vulgaris (e.g., beta blockers, anti-malaria drugs, lithium, 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 during the study that may affect the psoriasis vulgaris. Oestrogen therapy or any other medication known to affect cortisol levels or HPA axis integrity within 4 weeks prior to Visit 1. Enzymatic inductors (e.g., barbiturates, phenytoin, rifampicin) within 4 weeks prior to Visit 1. Systemic or topical cytochrome P450 inhibitors (e.g., ketoconazole) within 4 weeks prior to Visit 1. Hypoglycemic sulfonamides within 4 weeks prior to Visit 1. Antidepressive medications within 4 weeks prior to Visit 1. Clinical signs or symptoms of Cushing’s disease or Addison’s disease. Known or suspected severe renal insufficiency or severe hepatic disorders. Known or suspected disorders of calcium metabolism associated with hypercalcaemia. Known or suspected endocrine disorder that may affect the results of the ACTH challenge test. Known or suspected hypersensitivity to component(s) of the investigational products. Patients with diabetes mellitus. Irregular sleep schedules. Any clinically significant abnormality following review of screening biochemistry/haematology (blood and urine samples) and full physical examination. Current participation in any other interventional clinical study. Patients who have received treatment with any non-marketed d
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of once daily use of calcipotriol 25 mcg/g plus hydrocortisone 10 mg/g ointment on the hypothalamic-pituitary-adrenal (HPA) axis in patients with psoriasis vulgaris on the face and on the intertrigi-nous areas. To evaluate the effect of once daily use of calcipotriol 25 mcg/g plus hydrocortisone 10 mg/g ointment on the calcium metabolism in patients with psoriasis on the face and on the intertriginous areas. ;Secondary Objective: To evaluate the safety and efficacy of calcipotriol 25 mcg/g plus hydrocortisone 10 mg/g ointment applied once daily in the treatment of psoriasis vulgaris on the face and on the intertriginous areas. ;Primary end point(s): The adrenal response to the ACTH challenge test defined as the serum cortisol concentration obtained after 30 and 60 minutes at Week 4 and Week 8. Change in albumin corrected serum calcium from baseline to Weeks 4 and 8 and end of treatment. | — |
Countries
Germany, United Kingdom
Outcome results
None listed