Effect of Calcipotriol Plus Hydrocortisone Ointment on the HPA Axis and Calcium Metabolism in Patients with Psoriasis Vulgaris on the Face and on the Intertriginous Areas
- Conditions
- 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 Classification code 10050576 Term: Psoriasis vulgaris
- Registration Number
- EUCTR2007-005501-22-GB
- Lead Sponsor
- EO Pharmaceuticals Products Ltd. A/S (LEO Pharma A/S)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 35
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 5 cm² (the sum of all facial lesions) and on theface and intertriginous areas of at least 30 cm² (the sum of all facial and 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 childbearing 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 contraceptives on oestrogen-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
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) except stable treatment (same dose for at least 4 weeks) with methotrexate or fumaric acid within 2 weeks prior to Visit 1. Initiation of or increases in dose of methotrexate or fumaric acid within 4 weeks prior to Visit 1 or during the study is not allowed.
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 calci
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