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

Pfizer logo

Pfizer

Status and phase

Completed
Phase 1

Conditions

Psoriasis

Treatments

Drug: Betamethasone
Drug: Calcipotriene/calcipotriol
Drug: PF-06763809
Other: Vehicle

Study type

Interventional

Funder types

Industry

Identifiers

NCT03469336
C3561001
2017-002684-18 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

18 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

18 participants in 1 patient group

All subjects
Other group
Description:
All subjects will receive all six interventions/treatments applied to six different treatment fields.
Treatment:
Other: Vehicle
Drug: Betamethasone
Drug: Calcipotriene/calcipotriol
Drug: PF-06763809

Trial documents
2

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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