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Safety, Tolerability And Efficacy Study Of Topical PF-06763809 In Subjects With Mild To Moderate Chronic Plaque Psoriasis

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NCT03469336

Last updated on December 6, 2018
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FOR MORE INFORMATION
Study Location
bioskin GmbH
Hamburg, , 20095 Germany
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Psoriasis
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

- 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

- Target lesion(s) should be on the trunk or extremities (excluding palms/soles).

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

- History of skin sensitivity to topical prescription or non prescription products such
as creams, lotions and cosmetics

- Psoriasis guttata, psoriasis punctata, psoriasis erythrodermatica, and pustular
psoriasis

- Treatment with any biologics within 3 months prior to Day 1 of the study and during
the study

NCT03469336
Pfizer
Recruiting
Safety, Tolerability And Efficacy Study Of Topical PF-06763809 In Subjects With Mild To Moderate Chronic Plaque Psoriasis

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[email protected]

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Safety, Tolerability And Efficacy Study Of Topical PF-06763809 In Subjects With Mild To Moderate Chronic Plaque Psoriasis
A Phase 1, Randomized, Double-blind, Vehicle And Active Comparator-controlled, Psoriasis Plaque Test Study To Assess Safety, Tolerability, And Psoriatic Skin Infiltrate Thickness Following Repeated, Topical Doses Of Pf-06763809 Solution In Subjects With Mild To Moderate Chronic Plaque Psoriasis
The study is a randomized, double blinded, vehicle and active comparator controlled, multiple dose study in subjects with chronic plaque psoriasis. The study will have approximately 15 completers. Each subjects will receive three different topical doses of PF 06763809, PF 06763809 vehicle, and two active comparators. These will be applied to six different treatment fields for 18 days. The total duration of participation in the study will be approximately 7 weeks (minimum) to approximately 11 weeks (maximum), including the interval from Screening to the Follow up phone call visit.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description:
This study is a single arm multi-intervention study. The interventions are masked to participant, investigator, providers and assessors.

Primary Purpose: Treatment
Psoriasis
  • Drug: PF-06763809
    Three different concentrations will be administered to three different treatment fields: 2.3%, 0.8% and 0.23%
  • Other: Vehicle
    Vehicle matching PF-06763809.
  • Drug: Calcipotriene/calcipotriol
    Calcipotriene/calcipotriol 50 ug/mL solution
  • Drug: Betamethasone
    Betamethasone 1 mg/g solution
All subjects
All subjects will receive all six interventions/treatments applied to six different treatment fields.
Interventions:
  • Drug: PF-06763809
  • Other: Vehicle
  • Drug: Calcipotriene/calcipotriol
  • Drug: Betamethasone
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
15
March 2, 2019
February 6, 2019   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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
  • Target lesion(s) should be on the trunk or extremities (excluding palms/soles).

Exclusion Criteria:

  • History of skin sensitivity to topical prescription or non prescription products such as creams, lotions and cosmetics
  • Psoriasis guttata, psoriasis punctata, psoriasis erythrodermatica, and pustular psoriasis
  • Treatment with any biologics within 3 months prior to Day 1 of the study and during the study
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Not Provided
 
 
NCT03469336
C3561001
2017-002684-18 ( EudraCT Number )
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Plan to Share IPD: No
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/da...
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2018

ICMJE     Data element required by the

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

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