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A 12 Day Study To Evaluate A Topical Drug To Treat Plaque Psoriasis

Last updated on November 15, 2019

FOR MORE INFORMATION
Study Location
Bioskin GmbH
Hamburg, , 20095 Germany
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Psoriasis Vulgaris
Sex
Females and Males
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

- Healthy male and/or female subjects age 18 years and older, inclusive. Healthy is
defined as no clinically relevant abnormalities identified by a detailed medical
history, full physical examination, including blood pressure and pulse rate
measurement, 12 lead ECG or clinical laboratory tests.

- Subjects with psoriasis vulgaris in a chronic stable phase and with a plaque area of
mild to moderate severity sufficient for six treatment fields located in up to three
plaque areas.

- The target lesion(s) should be on the trunk or extremities (excluding palms/soles).
Psoriatic lesions on the knees or elbows are not to be used as a target lesion.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Subjects with psoriasis guttata, psoriasis punctata, psoriasis erythrodermatica,
psoriasis arthropathica and pustular psoriasis.

- Treatment with any systemic medications which in the opinion of the investigator
might counter or influence the trial aim (including anti psoriasis medications, eg,
corticosteroids, cytostatics or retinoids) or medications which are known to provoke
or aggravate psoriasis (eg, beta blocker, anti malarial drugs, lithium) or
phototherapy/psoralen+UVA (PUVA) within 4 weeks preceding the treatment phase of the
trial and during the trial.

- Treatment with any locally acting medications (including anti-psoriasis medications
like vitamin D analogues, dithranol) within 4 weeks of the treatment phase.

NCT02193815
Pfizer
Completed
A 12 Day Study To Evaluate A Topical Drug To Treat Plaque Psoriasis

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Pfizer Clinical Trials Contact Center

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[email protected]

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Descriptive Information
Brief Title  ICMJE A 12 Day Study To Evaluate A Topical Drug To Treat Plaque Psoriasis
Official Title  ICMJE A Phase 1, Single- Center, Randomized, Double-blind, Vehicle And Active Comparator-controlled Trial To Evaluate The Antipsoriatic Activity And Safety Of A Topically Applied Pf-06263276 Formulation In A Psoriasis Plaque Test
Brief SummaryThis is a vehicle and comparator controlled Proof of Mechanism (PoM) trial to evaluate the effect on psoriasis disease activity and safety of topically applied PF 06263276 in subjects with psoriasis vulgaris.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Psoriasis Vulgaris
Intervention  ICMJE
  • Drug: PF06263276
    4% PF 06263276 solution Daily dosage: approximately 8 mg PF 06263276 QD
  • Other: Vehicle
    Active ingredient-free vehicle to 4% solution
  • Drug: 2%Tofacitinib Ointment
    Daily Dosage: approximately 4 mg tofacitinib
  • Other: Vehicle
    Active ingredient-free vehicle to 2% Ointment
  • Drug: Daivonex
    Daivonex solution (50 ug/ml Calcipotriol) Daily Dosage of calcipotriol: approximately 0.01 mg
  • Drug: Daivonex Ointment
    Daivonex ointment (50 ug/g Calcipotriol) Daily Dosage of calcipotriol: approximately 0.01 mg
Study Arms  ICMJE Experimental: One Arm
Study treatments 1-6 Study drug, vehicle, Tofacitinib, vehicle, Daivonex solution and ointment
Interventions:
  • Drug: PF06263276
  • Other: Vehicle
  • Drug: 2%Tofacitinib Ointment
  • Other: Vehicle
  • Drug: Daivonex
  • Drug: Daivonex Ointment
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: March 4, 2015)
15
Original Estimated Enrollment  ICMJE
 (submitted: July 16, 2014)
20
Actual Study Completion Date  ICMJE February 2015
Actual Primary Completion DateFebruary 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male and/or female subjects age 18 years and older, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG or clinical laboratory tests.
  • Subjects with psoriasis vulgaris in a chronic stable phase and with a plaque area of mild to moderate severity sufficient for six treatment fields located in up to three plaque areas.
  • The target lesion(s) should be on the trunk or extremities (excluding palms/soles). Psoriatic lesions on the knees or elbows are not to be used as a target lesion.

Exclusion Criteria:

  • Subjects with psoriasis guttata, psoriasis punctata, psoriasis erythrodermatica, psoriasis arthropathica and pustular psoriasis.
  • Treatment with any systemic medications which in the opinion of the investigator might counter or influence the trial aim (including anti psoriasis medications, eg, corticosteroids, cytostatics or retinoids) or medications which are known to provoke or aggravate psoriasis (eg, beta blocker, anti malarial drugs, lithium) or phototherapy/psoralen+UVA (PUVA) within 4 weeks preceding the treatment phase of the trial and during the trial.
  • Treatment with any locally acting medications (including anti-psoriasis medications like vitamin D analogues, dithranol) within 4 weeks of the treatment phase.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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 NCT02193815
Other Study ID Numbers  ICMJE B5391003
2014-000068-16 ( EudraCT 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 DateMay 2016

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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