A phase IIa, multicenter, randomized, two-arm, observer-blind, vehicle and reference controlled proof of concept trial to investigate intra-individually (left/ right) the antipsoriatic efficacy and safety of once daily topical application of Valrubicin cream 1 % in comparison to vehicle and reference product in adult patients with stable plaque psoriasis
- Conditions
- Male or female subjects with stable plaque psoriasisMedDRA version: 13.1Level: LLTClassification code 10050576Term: Psoriasis vulgarisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders
- Registration Number
- EUCTR2010-023789-33-DE
- Lead Sponsor
- Valderm ApS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 46
Patients are eligible for the trial if all of the following apply:
1. Male or female patient of at least 18 years;
2. Mild to moderate stable plaque psoriasis for at least 12 months as determined by patient history and typical lesions;
3. Patients have to have at least two comparable plaques suitable as target plaques
located on the trunk or extremities and which are not positioned directly at the elbows, knees or lower legs; target plaques should be located on left/right side and in the same body region although not necessarily symmetrical;
4. Skin type I - IV;
5. Willingness to discontinue the use of own treatment and cosmetic products (e.g. soaps, creams, moisturizers) in the treatment areas and neighboring skin throughout the course of the trial;
6. Female patients of childbearing potential must either be surgically sterile (hysterectomy or tubal ligation) or agree to use a reliable method of contraception with a failure rate of less than 1 % per year when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intra uterine devices [IUDs], sexual abstinence or vasectomized partner;
7. Written informed consent obtained.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Patients will be excluded from participation if any of the following applies:
1. Patients requiring compulsory treatment;
2. Active skin disease apart from plaque psoriasis or tattoos in the target plaques;
3. Psoriasis erythrodermatica, psoriasis punctata and pustular psoriasis;
4. Known or suspected hypersensitivity to the active ingredient or any other ingredient of the IMPs and comparator;
5. Patients with severe liver and renal diseases;
6. Patients with known dysfunction of the calcium metabolism;
7. Evidence or history of drug- or alcohol abuse;
8. Pregnant women or women who intend to become pregnant during the trial or women of childbearing potential who are sexually active and practicing an unreliable method of birth control or will be lactating during the trial;
9. Any clinically significant condition, which in the opinion of the investigator makes the patient unsuitable for the trial in the four weeks before or during the trial;
10. Participation in any clinical trial within the last 60 days prior to the first administration of investigational drug in this trial;
11. Participation in a clinical trial for plaque psoriasis more than twice within 12 months prior to the first administration of investigational drug in this trial;
12. Participation in the previous trial (290408BS);
13. Known allergic reactions to components of the IMPs including comparator;
14. Local treatment with antipsoriatics (like vitamine D, dithranol, glucocorticosteroids) in the 4 weeks preceding and during the trial; and any topical antipsoriatic treatment on the plaques to be treated in this trial (including corticosteroids) in the 8 weeks preceding and during the trial;
15. Systemic treatment with antipsoriatics (e.g. retinoids or immunosuppressive therapy) or therapy with PUVA, selected ultraviolet photo-therapy in the three months preceding and during the trial;
16. Treatment with systemic or locally acting medications which might interact with the IMPs or impact the effect thereof (e.g. glucocorticosteroids, MAO inhibitors, anti-epileptic drugs, anti-psychotic drugs) or medications which are known to provoke or aggravate psoriasis, e.g. b-blocker, antimalarial and lithium drugs within two weeks before the beginning of the trial and during the trial;
17. Contraindications according to summary of product characteristics of the comparator;
18. If in the opinion of the investigator performing the initial examination the patient should not participate in the trial, e.g. due to probable noncompliance or inability to understand the trial and give adequately informed consent;
19. Patient is institutionalized because of legal or regulatory order;
20. Employees of bioskin, third parties associated with the trial, or the site.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the antipsoriatic efficacy of Valrubicin cream 1% in patients with plaque psoriasis in comparison to vehicle cream.;Secondary Objective: • To compare the efficacy of Valrubicin cream 1 % to Daivonex® 50 µg/g Creme<br>• To evaluate the tolerability and safety of Valrubicin cream 1 % in patients with plaque psoriasis in comparison to vehicle<br>• To investigate the efficacy of Valrubicin cream 1 % on skin thickness, skin morphology and biomarkers in plaque psoriasis in a subset of 12 patients (6 per treatment arm);Primary end point(s): Primary efficacy variable:<br>• Comparison of Valrubicin cream 1 % to vehicle cream with respect to change from<br>baseline in TSS (Total Severity Sign) score on day 29.
- Secondary Outcome Measures
Name Time Method