Study Of Safety, Tolerability And Effects Of PF-05175157... | NCT02100527

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

NCT02100527

Sponsor

Pfizer

Status

Withdrawn

Last Update Posted

May 13, 2014Estimated

Enrollment

0Actual

Phase

Phase 2

Conditions

Acne Vulgaris

Interventions

PF-05175157
Placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2014

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study canceled

Expanded Access Info

Start Date

Apr 2014

Primary Completion Date

Oct 2014Estimated

Completion Date

Oct 2014Estimated

First Submitted Date

Mar 27, 2014

First Submission Date that Met QC Criteria

Mar 31, 2014

First Posted Date

Apr 1, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 12, 2014

Last Update Posted Date

May 13, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PF-05175157	Experimental		Drug: PF-05175157
Placebo	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PF-05175157	Drug	200 mg (as 2x100 mg tablets) twice a day (BID) for 6 weeks	PF-05175157

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

References Module

Citations

Not provided

ID	Term
D017486	Acneiform Eruptions
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D012625	Sebaceous Gland Diseases