chronic stable plaque psoriasis MedDRA version: 19.1 Level: LLT Classification code 10071117 Term: Plaque psoriasis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 19.1 Level: LLT Classification code 10050576 Term: Psoriasis vulgaris System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 19.1 Level: PT Classification code 10037153 Term: Psoriasis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Product Name: calcipotriol-betamethasone
Product Code: TEST
Pharmaceutical Form: Ointment
INN or Proposed INN: Calcipotriol monohydrate
CAS Number: 147657-22-5
Other descriptive name: CALCIPOTRIOL MON
Sponsors
Dermapharm AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [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. 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
Exclusion criteria
Exclusion criteria: [1] History of hypersensitivity or intolerance to any active substance or any of the excipients of the study medication. [2] Current diagnosis of unstable forms of psoriasis in the area(s) to be treated with study medication, including guttate, erythrodermic, exfoliative, or pustular psoriasis. [3] Other inflammatory skin disease in the area(s) to be treated with study medication that may confound the evaluation of plaque psoriasis (e.g., atopic dermatitis, contact dermatitis, tinea corporis). [4] Presence of pigmentation, extensive scarring, pigmented lesions, or sunburn in the area(s) to be treated with study medication which could interfere with efficacy and safety evaluations. [5] History of psoriasis unresponsive to topical treatments. [6] Presence of any of the following skin conditions in the treatment area: viral infections (e.g. herpes simplex, herpes zoster, varicella), fungal and bacterial skin infections, parasitic infections, skin manifestation in relation to tuberculosis, perioral dermatitis, atrophic skin, striae atrophicae, fragility of sin veins, ichthyosis, acne vulgaris, acne rosacea, dermal ulcers and wounds. [7] Other severe acute or chronic concomitant disease with severe impairment of the general condition. [8] Other concomitant diseases which may - taking the present knowledge into account - influence the parameters evaluated in the study in a way that an objective evaluation would be impossible. [9] 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 3 times the upper limit of normal). [10] Use of topical anti-psoriatic therapy (including topical retinoids, topical corticosteroids, vitamin D analogues, salicylic acid, anthralin, coal tar) within 2 weeks prior to baseline (Visit 2) and during the study. [11] Use of systemic corticosteroids (including inhaled and nasal steroids) within 4 weeks prior to baseline (Visit 2) and during the study. [12] 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. [13] Use of immunosuppressive drugs (e.g., tacrolimus, pimecrolimus) or oral retinoids (e.g., acitretin) within 2 months prior to baseline (Visit 2) and during the study. [14] Chemotherapy or radiation therapy within 3 months prior to baseline (Visit 2) and during the study. [15] Use of systemic anti-psoriatic biologic therapy (e.g., alefacept, etanercept, infliximab, efalizumab, adalimumab) within 6 months prior to baseline (Visit 2) and during the study. [16] Psoralen + UVA (PUVA) therapy or UVB therapy within 1 month prior to baseline (Visit 2) and during the study. [17] Use of calcium supplements during the study. [18] More than 400 IU/day of vitamin D or vitamin D analogues during the study. [19] Initiation of or changes in non-anti-psoriatic concomitant medication(s) that could affect psoriasis (e.g., beta-blockers, lithium, ACE inhibitors) during the study. [20] Initiation of or changes to concomitant medication that could affect calcium metabolism (e.g., antacids, thiazide and/or loop diuretics, antiepileptics) during the study. [21] Use of tanning booth, sun lamps, or non-prescription UV light sources within 2 weeks prior to baseline (Visit 2) and during the study. [22] Use of topica
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that topical treatment with the generic calcipotriol-betamethasone ointment formulation is therapeutically equivalent to the originator product Daivobet® ointment in the treatment of chronic stable plaque psoriasis as determined by the percentage reduction in modified Psoriasis Area and Severity Index (PASI).;Secondary Objective: - to demonstrate that topical treatment with the generic calcipotriol-betamethasone ointment formulation is superior to vehicle (company’s ointment formulation) in the treatment of chronic stable plaque psoriasis as determined by the percentage reduction in modified Psoriasis Area and Severity Index (PASI). - to assess the efficacy of the generic calcipotriolbetamethasone ointment formulation in comparison to the originator product Daivobet® and vehicle (company’s ointment formulation) in the treatment of chronic stable plaque psoriasis in terms of improvement in: o Investigator's Psoriasis Global Assessment (IPGA) score; o Body Surface Area (BSA) affected by psoriasis; o Patient’s Psoriasis Global Assessment (PPGA) score. - to assess the safety and local tolerance of the generic calcipotriol-betamethasone ointment formulation in comparison to the originator product Daivobet® and vehicle (company’s ointment formulation).;Primary end point(s): Mean percent change from baseline in modified PASI score at the end of week 4. This endpoint undergoes descriptive and comparative statistical Evaluation.;Timepoint(s) of evaluation of this end point: After completion of the clinical part of the trial and database closure and blind review. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Mean percent change from baseline in modified PASI score at the end of week 1. - Proportion of patients with a reduction in modified PASI score of >75% between baseline and end of week 4 (responder). - Proportion of patients with a reduction in modified PASI score of >50% between baseline and end of week 4. - Mean percent change from baseline in IPGA at the end of week 1 and week 4. - Mean percent change from baseline in PPGA at the end of week 1 and week 4. - Proportion of patients with controlled disease (defined as "clear" or "almost clear") in IPGA at the end of week 4. - Proportion of patients with controlled disease (defined as "clear" or "almost clear") in PPGA at the end of week 4. - Mean percent change from baseline in BSA affected by psoriasis at the end of week 1 and week 4.;Timepoint(s) of evaluation of this end point: After completion of the clinical part of the trial and database closure. These endpoints undergo descriptive and comparative statistical Evaluation. | — |
Countries
Bulgaria
Contacts
Public ContactClinical Research Department
Dermapharm AG
Outcome results
None listed