Study Of Safety, Tolerability And Effects Of PF-05175157 In Adults With Moderate To Severe Acne Vulgaris

NCT ID: NCT02100527

Last Updated: 2014-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2014-10-31

Brief Summary

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This is a 6 week study to characterize the safety, tolerability and effects of PF-05175157 administered for 6 weeks in subjects with moderate to severe acne vulgaris.

Detailed Description

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Conditions

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Acne Vulgaris

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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PF-05175157

Group Type EXPERIMENTAL

PF-05175157

Intervention Type DRUG

200 mg (as 2x100 mg tablets) twice a day (BID) for 6 weeks

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

placebo matching 200 mg (as 2x100 mg tablets) BID for 6 weeks

Interventions

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PF-05175157

200 mg (as 2x100 mg tablets) twice a day (BID) for 6 weeks

Intervention Type DRUG

Placebo

placebo matching 200 mg (as 2x100 mg tablets) BID for 6 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Males 18 years or older diagnosed with moderate to severe acne vulgaris who are otherwise healthy.
* Normal spirometry at screening (FEV1 and FVC (Forced Vital Capacity)at least 80% predicted).
* Minimum of 20 inflammatory lesions on the face.
* Willing to discontinue other acne treatments prior to and during the study period through follow-up.

Exclusion Criteria

* Subjects with active nodulocystic acne.
* Subjects unwilling to comply with lifestyle guidelines, commit to study visits, and perform study procedures.
* History of dry eye or other known disease that affects the sclera or cornea.
* History of pulmonary disease or inability to adequately perform testing.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Related Links

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Other Identifiers

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B1731019

Identifier Type: -

Identifier Source: org_study_id

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