A multi-centre, randomised, double-blind, parallel-group phase III study to investigate the efficacy, safety, and tolerability of a generic calcipotriol-betamethasone ointment formulation compared to Daivobet® and vehicle in the treatment of adult patients with chronic stable plaque psoriasis
- Conditions
- Chronic stable plaque psoriasis.MedDRA version: 17.0Level: LLTClassification code 10071117Term: Plaque psoriasisSystem Organ Class: 100000004858Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2013-002861-20-PL
- Lead Sponsor
- ek Pharmaceuticals d.d.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 411
1] Male or female patients =18 years of age.
[2] Clinical diagnosis of chronic stable (at least 6 months) plaque psoriasis amenable to topical treatment and involving arms and/or legs and/or trunk (but excluding face, scalp, genitals and intertriginous areas).
[3] Psoriasis affecting less than 30% of the body surface area (BSA).
[4] A modified PASI score of =5 to =15 at baseline (Visit 2).
[5] Female patients of childbearing potential must have a negative pregnancy test prior to randomisation and must agree to use an appropriate method of contraception during the study.
[6] Patients willing and able (e.g. mental and physical condition) to participate in all aspects of the study, including use of medication, completion of subjective evaluations, attending scheduled visits, and compliance with protocol requirements as evidenced by providing signed written informed consent.
[7] An albumin-corrected serum calcium level below the upper reference range limit.
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 411
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 411
- History of hypersensitivity or intolerance to any active substance or any of the excipients of the study medication
- History of hypersensitivity to Adrenocorticotropic hormone (ACTH), Synacthen® or Synacthen® Depot
- Current diagnosis of unstable forms of psoriasis in the area(s) to be treated with study medication, including guttate, erythrodermic, exfoliative, or pustular psoriasis
- Other inflammatory skin disease in the area(s) to be treated with study medication that may confound the evaluation of plaque psoriasis
- Presence of pigmentation, extensive scarring, pigmented lesions, or sunburn in the area(s) to be treated with study medication which could interfere with efficacy evaluation
- History of psoriasis unresponsive to topical treatments
- Viral lesions of the skin
- Fungal or bacterial skin infections
- Parasitic infections
- Skin manifestations in relation to tuberculosis or syphilis
- Perioral dermatitis
- Atrophic skin, striae atrophicae
- Fragility of skin veins
- Ichthyosis
- Acne vulgaris, acne rosacea, rosacea
- Dermal ulcers, wounds
- Perianal and genital pruritus
- Allergic disorders or susceptibility for allergic reactions
- Active infectious diseases
- Peptic ulcer
- Refractory heart failure
- Any of the following conditions, whether known or suspected: endocrine disorders, Cushing’s syndrome, primary adrenocortical insufficiency, diabetes mellitus
- Current or past history or signs/symptoms suggestive of a clinically significant abnormality in calcium homeostasis with hypercalcaemia, vitamin D toxicity, severe renal impairment (CRCL <30 ml/min), or severe hepatic disorder (total bilirubin, AST, ALT, GGT, or AP >3 times the upper limit of normal)
- Use of topical anti-psoriatic therapy within 2 weeks prior to baseline (Visit 2) and during the study
- Use of systemic corticosteroids within 3 months prior to baseline (Visit 2) and during the study
- Use of other systemic anti-psoriatic therapy, systemic antibiotics, or systemic anti-inflammatory agents within 1 month prior to baseline (Visit 2) and during the study
- Use of immunosuppressive drugs or oral retinoids within 2 months prior to baseline (Visit 2) and during the study
- Chemotherapy or radiation therapy within 3 months prior to baseline (Visit 2) and during the study
- Use of systemic anti-psoriatic biologic therapy within 6 months prior to baseline (Visit 2) and during the study
- Psoralen + UVA (PUVA) therapy or UVB therapy within 1 month prior to baseline (Visit 2) and during the study
- Use of calcium supplements during the study
- More than 400 IU/day of vitamin D or vitamin D analogues during the study
- Initiation of or changes in non-anti-psoriatic concomitant medication(s) that could affect psoriasis during the study
- Initiation of or changes to concomitant medication that could affect calcium metabolism during the study
- Change in sleep pattern within 1 month prior to baseline (Visit 2) and during the study
- Initiation of or changes in oestrogen therapy (including contraceptives), antidepressant medications and any other medication known to affect cortisol levels or HPA axis integrity within 1 month prior to baseline (Visit 2) and during the study
- Use of CYP P450 3A4 inducers within 1 month prior to baseline (Visit 2) and during the study
- Use of systemic CYP P450 3A4 inhibitors (e.g. ketoconazole, itraconazole, metronidazole) within 1 month prior to baseline (Visit 2) and during the study
- Use of topical CYP P450 3A4 inhibitors (e.g.
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