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

A Phase 2a Randomized, Double-blind, Placebo-Controlled Study To Evaluate The Safety, Tolerability And Effects Of PF-05175157 On Moderate To Severe Acne Vulgaris In Adult Subjects

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02100527

Enrollment

Registered

2014-04-01

Start date

2014-04-30

Completion date

2014-10-31

Last updated

2014-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acne Vulgaris

Keywords

safety, tolerability, pharmacokinetics, oral dosing, moderate to severe acne vulgaris

Brief summary

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.

Interventions

DRUGPF-05175157

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

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Safety and tolerability	Weeks 2, 4, and 6	Physical examination, pulmonary function testing, adverse event monitoring, ECGs, vital signs, laboratory tests

Secondary

Measure	Time frame	Description
Sebum measurements	Weeks 2, 4, and 6	Change from baseline in amount and rate of sebum excretion
Pharmacokinetics of PF-05175157	Weeks 2, 4, and 6	Plasma concentrations

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026