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

Last updated on November 18, 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.
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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Psoriasis Vulgaris, Psoriasis Arthropathica, Pustular Psoriasis, Erythrodermic Psoriasis
NCT03885089
All Genders
0+
Years
Tokyo,
Descriptive Information
Brief Title  ICMJE A Phase I Study to Assess Novel Ointment in a Psoriasis Plaque Test
Official Title  ICMJE 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
Brief SummaryTo investigate dose-response relationship, antipsoriatic efficacy and safety of different concentrations of topical formulations of AN2728 in patients with psoriasis vulgaris
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Psoriasis
Intervention  ICMJE
  • 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 %
Study Arms  ICMJE
  • 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 %
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 29, 2008)
12
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 7, 2007
Actual Primary Completion DateDecember 7, 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Gender Based Eligibility:Yes
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00762658
Other Study ID Numbers  ICMJE AN2728-PSR-102
2007-003983-23 ( EudraCT Number )
C3291021 ( Other Identifier: Alias Study Number )
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateFebruary 2019

ICMJE     Data element required by the

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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