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

Pfizer

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Acne Vulgaris

Interventions

PF-05175157DRUG

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

PlaceboDRUG

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

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Safety and tolerability

Physical examination, pulmonary function testing, adverse event monitoring, ECGs, vital signs, laboratory tests

Time frame: Weeks 2, 4, and 6

Secondary Outcomes

Sebum measurements

Change from baseline in amount and rate of sebum excretion

Time frame: Weeks 2, 4, and 6

Pharmacokinetics of PF-05175157

Plasma concentrations

Time frame: Weeks 2, 4, and 6

Data from ClinicalTrials.gov

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