A multicenter, randomized, double-blind, placebo-controlled, intraindividual-comparison phase IIa trial to evaluate the efficacy and safety of 2% AVT-02 UE ointment in an every other day treatment of mild to moderate psoriasis vulgaris
- Conditions
- psoriasis vulgarisMedDRA version: 9.1Level: LLTClassification code 10050576Term: Psoriasis vulgaris
- Registration Number
- EUCTR2008-002765-31-DE
- Lead Sponsor
- Avontec GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- Not specified
- Male, aged between 18 and 75 years
- subjects must habe a diagnosis of mild to moderate plaque-type psoriasis (PASI <= 10)
- >= 2 symmetrical psoriasis lesions on the extremities each of at least 12 cm2
- Written informed consent
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
;
- Male, aged between 18 and 75 years
- subjects must habe a diagnosis of mild to moderate plaque-type psoriasis (PASI <= 10)
- >= 2 symmetrical psoriasis lesions on the extremities each of at least 12 cm2
- Written informed consent
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
?Significant skin diseases (other than plaque-type psoriasis), especially any condition (including atopy and related disorders) or treatment that may interfere with the skin barrier function and/or may have an influence on the immune response
?Significant medical condition or treatment that may have an influence on the immune response (e.g. auto immune diseases)
?Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis
?Screening laboratory values > Grade 1 (according to WHO Toxicity Criteria by Grade)
?Administration of any biologic within 3 months prior to study entry
?Administration of any other systemic anti-psoriatic drug (such as systemic corticosteroids, ciclosporin, MTX, fumaric acid esters) within 30 days prior to study entry
?Phototherapy (e.g. UVB, PUVA) within 14 days prior to study entry
?Administration of any topical anti-psoriatic drug within 14 days prior to study entry
?Known adverse reactions of any severity or hypersensitivity to any ingredient of 2% AVT-02 UE ointment
?History or presence of malignant disease (other than surgically removed basal cell carcinoma) and/or auto immune diseases (e.g. multiple sclerosis)
?Blood donation and loss of more than 400 ml 8 weeks prior to inclusion into study
?HIV infection (has to be excluded by laboratory test prior to randomization)
?Other active infectious diseases
?Alcohol abuse (has to be excluded by laboratory test prior to randomization)
?Major surgery 4 weeks prior to inclusion into study
?Vaccination with 6 days prior to enrolment and during the study
?Excessive UV-exposure 4-weeks prior to enrolment and during the conduct of the study
?Subjects with partner of child-bearing potential and their partners should use a highly effective method of birth control (failure rate < 1% per year), such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner.
?Subjects who are – in the opinion of the investigator – unreliable, and/or non-compliant, and/or who present with any condition or treatment (including cosmetic products) that may interfere with the conduct of the trial
?Participation in any other clinical trial within 4 weeks prior or during this trial
;
?Significant skin diseases (other than plaque-type psoriasis), especially any condition (including atopy and related disorders) or treatment that may interfere with the skin barrier function and/or may have an influence on the immune response
?Significant medical condition or treatment that may have an influence on the immune response (e.g. auto immune diseases)
?Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis
?Screening laboratory values > Grade 1 (according to WHO Toxicity Criteria by Grade)
?Administration of any biologic within 3 months prior to study entry
?Administration of any other systemic anti-psoriatic drug (such as systemic corticosteroids, ciclosporin, MTX, fumaric acid esters) within 30 days prior to study entry
?Phototherapy (e.g. UVB, PUVA) within 14 days prior to study entry
?Administration of any topical anti-psoriatic drug within 14 days prior to study entry
?Known adverse reactions of any severity or hypersensitivity to any ingredient of 2% AVT-02 UE ointment
?History or presence of malignant disease (other than surgically removed basal cell carcinoma) and/or auto immune diseases (e.g. multiple sclerosis)
?Blood donation and loss of more than 400 ml 8 weeks prior to inclusion into study
?HIV infection (has to be excluded by laboratory test prior to randomization)
?Other active infectious diseases
?Alcohol abuse (has to be excluded by laboratory test prior to randomization)
?Major surgery 4 weeks prior to inclusion into study
?Vaccination with 6 days prior to enrolment and during the study
?Excessive UV-exposure 4-weeks prior to enrolment and during the conduct of the study
?Subjects with partner of child-bearing potential and their partners should use a highly effective method of birth control (failure rate < 1% per year), such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner.
?Subjects who are – in the opinion of the investigator – unreliable, and/or non-compliant, and/or who present with any condition or treatment (including cosmetic products) that may interfere with the conduct of the trial
?Participation in any other clinical trial within 4 weeks prior or during this trial
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