A phase IIa, single-center, randomized, observer-blind, placebo- and reference-controlled proof of concept study with intraindividual comparison of treatments to investigate the safety and antipsoriatic efficacy of topical valrubicin formulations in a psoriasis plaque test - Efficacy and tolerability of varubicin cream in concentrations of 0.5 % and 1 % in a PPT

Active, not recruiting

• Conditions: Male or female subjects with chronic plaque psoriasis; MedDRA version: 12.1Level: LLTClassification code 10050576Term: Psoriasis vulgaris

• Registration Number: EUCTR2009-017692-18-DE
• Lead Sponsor: Valderm ApS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12-28
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patients are eligible for the study if all of the following apply:
1. Male or female patient <= 18 years;
2. Plaque psoriasis as determined by patient history and typical lesions;
3. Sufficient number of stable psoriatic plaques with an area sufficient for the occlusive and non-occlusive application and having the target plaques located on the trunk or extremities (lower legs, knees and elbows should be avoided);
4. Skin type I-IV (12);
5. Willingness to discontinue the use of own treatment and cosmetic products (e.g. soaps, creams, moisturizers) in the treatment areas throughout the course of the study;
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

Exclusion Criteria

Patients will be excluded from participation if any of the following applies:
1.Patients requiring treatment compulsory;
2.Active skin disease apart from plaque psoriasis or tattoos in the test fields;
3.Psoriasis erythrodermatica, psoriasis punctata and pustular psoriasis or extended chronic stationary forms of psoriasis;
4.Known or suspected hypersensitivity to the active ingredient or any other ingredient of the study preparations or comparators, occlusive dressing or test chamber;
5.Patients with severe liver and renal diseases;
6.Patients with known dysfunction of the calcium metabolism;
7.Patients with acne, pruritus anogenitalis, rosacea, perioral dermatitis, specific skin problems (skin tuberculosis, syphilic skin diseases), vaccination reactions, skin infections caused by viruses, bacteria or fungi in the test fields (plaques) to be treated;
8.Evidence of drug- or alcohol abuse;
9.Pregnant women or women who intend to become pregnant during the study or women of childbearing potential who are sexually active and practicing an unreliable method of birth control or will be lactating during the study;
10.Any clinically significant condition, which in the opinion of the investigator makes the patient unsuitable for the study in the four weeks before or during the study;
11.Participation in any clinical study within the last 30 days prior to the first administration of investigational drug in this study;
12.Known allergic reactions to components of the study preparations or comparators;
13.Local treatment with antipsoriatics (like vitamine D, dithranol, glucocorticosteroids; except for salicylic acid in vaseline) in the 4 weeks preceding and during the study; and any topical antipsoriatic treatment on the plaques to be treated in this study (including corticosteroids) in the 8 weeks preceding and during the study;
14.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 study;
15.Treatment with systemic or locally acting medications which might interact with the study drugs 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 study and during the study;
16.Contraindications according to summary of product characteristics of the reference drugs;
17.If in the opinion of the investigator performing the initial examination the patient should not participate in the study, e.g. due to probable noncompliance or inability to understand the study and give adequately informed consent;
18.Patient is institutionalized because of legal or regulatory order;
19.Employees of bioskin, third parties associated with the study, or the study site.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified