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This study compares clinically and microscopically the response to two treatments, a steroid in cream and a foam that contains a steroid and a vitamin D analogue in patients with plaque psoriasis.

Phase 1
Conditions
Plaque psoriasis
Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Registration Number
EUCTR2017-004451-24-ES
Lead Sponsor
Fundació Clínic per a la Reserca Biomèdica
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Authorised-recruitment may be ongoing or finished
Sex
All
Target Recruitment
36
Inclusion Criteria

Patients who agree to participate in the study and sign the informed consent (IC).
Patients diagnosed clinically and / or histologically from plaque psoriasis.
Men or women = 18 years.
Patients willing to comply with the requirements of the protocol and with the capacity to do so.
Outpatient patients
Patients who are candidates for treatment with any of the study medications.
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 36
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Hypersensitivity to any of the active principles or any of the excipients that appear listed in the technical data sheet of the study drugs.
Erythrodermic, exfoliative or pustular psoriasis.
Patients with known disorders in calcium metabolism.
Acute renal failure.
Acute liver disorders.
Facial or genital psoriasis.
Patients with viral skin lesions, fungal or bacterial skin infections, parasitic infections, skin manifestations in relation to tuberculosis, perioral dermatitis, atrophic skin, atrophic streaks, fragility of skin veins, ichthyosis, acne vulgaris, acne Rosacea, rosacea, ulcers and wounds.
Systemic treatment including cyclosporin A, methotrexate and steroids in the last 4 weeks.
Patients who have received systemic treatment with biological therapies, commercialized or not, with possible effect on plaque psoriasis during the following periods:
- etanercept: 4 weeks before visit 1 (week 0)
- adalimumab, alefacept, infliximab: 2 months before visit 1 (week 0)
- ustekinumab; 4 months prior to visit 1 (week 0)
- experimental products: 4 weeks or 5 half-lives (whichever is longer) prior to visit 1 (week 0)
Patients who have received topical treatment in the last 15 days.
Patients who have received treatment with phototherapy during the following periods:
- PUVA: 4 weeks before visit 1 (week 0)
- UV-B: 2 weeks before visit 1 (week 0)
History of concomitant serious systemic inflammatory cutaneous diseases.
Pregnant or lactating women
Patients who have participated in another clinical study in the 30 days prior to randomization.

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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