ot applicable

Phase 1

Conditions: chronic stable plaque psoriasis
MedDRA version: 19.1Level: LLTClassification code 10071117Term: Plaque psoriasisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 19.1Level: LLTClassification code 10050576Term: Psoriasis vulgarisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 19.1Level: PTClassification code 10037153Term: PsoriasisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Registration Number: EUCTR2016-001568-12-BG

Lead Sponsor: Dermapharm AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 411

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

[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 <30 ml/min), or severe hepatic disorder (total bilirubin, AST, ALT, GGT, or AP >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