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 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.

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-004451-24-ES

Enrollment

Registered

2017-11-17

Start date

2018-01-23

Completion date

Unknown

Last updated

2018-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Plaque psoriasis

Interventions

Trade Name: Enstilar Pharmaceutical Form: Cutaneous foam Trade Name: Clovate Pharmaceutical Form: Cream

Eligibility

Sex/Gender

All

Inclusion 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective is to define the relationship that exists between the clinical and microscopic evaluation in a target lesion (changes produced at the tissue and cell level) and the secondary effects evaluated microscopically in the psoriatic plaque after the treatment with clobetasol cream only and with Calcipotriol / Betamethasone dipropionate in foam as the only treatment.;Secondary Objective: Clinical and microscopic evaluation of the recurrence of the disease after clearance in the different treatment arms of the study. Evaluation of the safety and tolerability of the different treatments of the study. Evaluation of the level of patient satisfaction with the treatment received in the study.;Primary end point(s): Comparison of the clinical response and microscopic changes of the key identifiers for plaque psoriasis in the different treatment arms (Cal / BD and clobetasol) in adult patients affected by plaque psoriasis and treated for a period of up to 4 weeks.;Timepoint(s) of evaluation of this end point: Throughout the study (from visit 1 to visit 5)	—

Measure

Time frame

Main Objective: The main objective is to define the relationship that exists between the clinical and microscopic evaluation in a target lesion (changes produced at the tissue and cell level) and the secondary effects evaluated microscopically in the psoriatic plaque after the treatment with clobetasol cream only and with Calcipotriol / Betamethasone dipropionate in foam as the only treatment.;Secondary Objective: Clinical and microscopic evaluation of the recurrence of the disease after clearance in the different treatment arms of the study. Evaluation of the safety and tolerability of the different treatments of the study. Evaluation of the level of patient satisfaction with the treatment received in the study.;Primary end point(s): Comparison of the clinical response and microscopic changes of the key identifiers for plaque psoriasis in the different treatment arms (Cal / BD and clobetasol) in adult patients affected by plaque psoriasis and treated for a period of up to 4 weeks.;Timepoint(s) of evaluation of this end point: Throughout the study (from visit 1 to visit 5)

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Secondary

Measure	Time frame
Secondary end point(s): Evaluate and compare the significant clinical and microscopic changes detectable related to side effects during treatment in the 2 arms of the study. To assess and compare the timing and clinical and microscopic characteristics of the recurrence of plaque psoriasis after treatment in the 2 arms of the study. Evaluate the degree of patient satisfaction with the medication after treatment in both arms of the study;Timepoint(s) of evaluation of this end point: Throughout the study (from visit 1 to visit 5)	—

Measure

Time frame

Secondary end point(s): Evaluate and compare the significant clinical and microscopic changes detectable related to side effects during treatment in the 2 arms of the study. To assess and compare the timing and clinical and microscopic characteristics of the recurrence of plaque psoriasis after treatment in the 2 arms of the study. Evaluate the degree of patient satisfaction with the medication after treatment in both arms of the study;Timepoint(s) of evaluation of this end point: Throughout the study (from visit 1 to visit 5)

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Countries

Spain

Contacts

Public ContactCristina Sacristán

Trialance

csacristan@trialance.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026