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

Last updated on May 11, 2018

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.
Show details

- male subjects aged 18 years or older;

- subjects with psoriasis vulgaris in a chronic stable phase and stable plaques with an
area sufficient for six 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.
Show details

- 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 (except for salicylic acid in vaseline) in the 4
weeks preceding and during the study (corticosteroids 8 weeks);

- 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. glucocorticosteroids, MAO inhibitors, anti-epileptic drugs,
anti-psychotic drugs) or medications which are known to provoke or aggravate
psoriasis, e.g. ?-blocker, antimalarial 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;

- evidence of drug abuse;

- UV-therapy within four weeks before beginning and during the study;

- symptoms of a clinically significant illness that may influence the outcome of the
study in the four weeks before and during the study;

- participation in another clinical trial involving pharmaceutical products in the four
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.

NCT00762658
Pfizer
Completed
A Phase I Study to Assess Novel Ointment in a Psoriasis Plaque Test

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A Phase I Study to Assess Novel Ointment in a Psoriasis Plaque Test
A Phase I, Randomized, Observer-Blind, Single-Center, Vehicle- and Comparator-Controlled, Initial Dose-Ranging Study to Assess the Antipsoriatic Efficacy of Different Concentrations of AN2728 Ointment in a Psoriasis Plaque Test
To investigate dose-response relationship, antipsoriatic efficacy and safety of different concentrations of topical formulations of AN2728 in patients with psoriasis vulgaris

The study will be performed in 12 male subjects with stable psoriatic plaques. The study preparations and the comparators will be tested observer-blind. Treatments will be randomly assigned to the test fields. All subjects will receive all treatments, with intraindividual comparison of the treatments.

Altogether six test fields will be examined per subject (three active AN2728 ointments of different concentrations: 5 %, 2 % and 0.5 %, the active ingredient-free vehicle, a marketed corticoid preparation and a marketed topical immunomodulator). The test fields will be treated occlusively over a study period of 12 days. A topical application of approximately 200 uL of each assigned intervention will be administered per treatment, for a total of 10 treatments over a 12-day treatment period.

Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Psoriasis
  • Drug: AN2728 Ointment, 5%
  • Drug: AN2728 Ointment, 2%
  • Drug: AN2728 Ointment, 0.5%
  • Drug: AN2728 Ointment Vehicle
  • Drug: Betnesol®-V Creme, 0.1%
    Other Name: betamethasone 0.1%
  • Drug: Protopic® Ointment, 0.1 %
    Other Name: tacrolimus 0.1 %
  • Experimental: 1
    AN2728 Ointment, 5%
    Intervention: Drug: AN2728 Ointment, 5%
  • Experimental: 2
    AN2728 Ointment, 2%
    Intervention: Drug: AN2728 Ointment, 2%
  • Experimental: 3
    AN2728 Ointment, 0.5%
    Intervention: Drug: AN2728 Ointment, 0.5%
  • Placebo Comparator: 4
    AN2728 Ointment Vehicle
    Intervention: Drug: AN2728 Ointment Vehicle
  • Active Comparator: 5
    Betnesol®-V Creme (betamethasone 0.1 %)
    Intervention: Drug: Betnesol®-V Creme, 0.1%
  • Active Comparator: 6
    Protopic® Ointment (tacrolimus 0.1 %)
    Intervention: Drug: Protopic® Ointment, 0.1 %
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
December 2007
December 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • male subjects aged 18 years or older;
  • subjects with psoriasis vulgaris in a chronic stable phase and stable plaques with an area sufficient for six 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:

  • 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 (except for salicylic acid in vaseline) in the 4 weeks preceding and during the study (corticosteroids 8 weeks);
  • 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. glucocorticosteroids, MAO inhibitors, anti-epileptic drugs, anti-psychotic drugs) or medications which are known to provoke or aggravate psoriasis, e.g. ?-blocker, antimalarial 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;
  • evidence of drug abuse;
  • UV-therapy within four weeks before beginning and during the study;
  • symptoms of a clinically significant illness that may influence the outcome of the study in the four weeks before and during the study;
  • participation in another clinical trial involving pharmaceutical products in the four 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.
Sexes Eligible for Study: Male
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00762658
AN2728-PSR-102
No
Not Provided
Not Provided
Karl Beutner, MD, PhD, Anacor Pharmaceuticals, Inc.
Pfizer
Not Provided
Study Director: Karl Beutner, MD, PhD Pfizer
Pfizer
October 2008

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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1-800-718-1021

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