EUCTR2017-004451-24-ES
Active, not recruiting
Phase 1
Phase IV, unicentric, open-label, randomized clinical trial to evaluate clinic and non-invasive response to clobetasol cream versus betamethasone dipropionate and calcipotriol foam treatments in plaque psoriasis.
Fundació Clínic per a la Reserca Biomèdica0 sites36 target enrollmentNovember 17, 2017
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Plaque psoriasis
- Sponsor
- Fundació Clínic per a la Reserca Biomèdica
- Enrollment
- 36
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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\)
Outcomes
Primary Outcomes
Not specified
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