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A Phase I Study to Assess Novel Cream in a Psoriasis Plaque Test

Last updated on February 23, 2019

FOR MORE INFORMATION
Study Location
Bioskin GmbH
Hamburg, , 10117 Germany
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Psoriasis
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- male subjects aged 18 years or older

- subjects with psoriasis vulgaris in a chronic stable phase and stable plaques with an
area sufficient for five treatment fields

- the physical examination must be without disease findings unless the investigator
considers an abnormality to be irrelevant to the outcome of the study

- written informed consent obtained

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- subjects with psoriasis guttata or pustular psoriasis

- subjects who require systemically acting medications for the treatment of psoriasis,
which might counter or influence the study objectives, e.g. corticosteroids,
cytostatics

- local treatment with antipsoriatics (like vitamin D, dithranol, glucocorticosteroids;
except for salicyclic acid in vaseline) in the 4 weeks preceding and during the study;
and any antipsoriatic treatment on the plaques (including corticosteroids, except for
salicyclic acid) in the 8 weeks preceding and during the study.

- systemic treatment with antipsoriatics in the three months preceding and during the
study

- treatment with systemic or locally acting medications which might counter or influence
the study aim (e.g. MAO inhibitors, anti-epileptic drugs, anti-psychotic drugs) or
medications which are known to provoke or aggravate psoriasis, e.g. Beta-blocker,
antimalarial drugs and lithium drugs within two weeks before the beginning of the
study and during the study.

- known allergic reactions to the active ingredients or other components of the study
preparations or comparators

- blood pressure and heart rate outside the following allowed ranges: systolic blood
pressure 80-160 mm Hg, diastolic blood pressure 60 - 100 mm Hg, heart rate 40-120
beats/min

- evidence of drug abuse

- UV-therapy within 4 weeks before beginning and during the study

- Symptoms of a clinically significant illness that may influenced the outcome of the
study in the 4 weeks before and during the study

- participation in another clinical trial involving pharmaceutical products in the 4
weeks preceding and during the study

- in the opinion of the investigator or physician 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

- subject is institutionalized because of legal or regulatory order

NCT00763204
Pfizer
Completed
A Phase I Study to Assess Novel Cream in a Psoriasis Plaque Test

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[email protected]

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