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.
- Conditions
- Plaque psoriasisTherapeutic 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
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
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
Name Time Method
- Secondary Outcome Measures
Name Time Method