NCT02100527

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2014

Shorter than P25 for phase_2

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 1, 2014

Completed
Same day until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

May 13, 2014

Status Verified

May 1, 2014

Enrollment Period

6 months

First QC Date

March 27, 2014

Last Update Submit

May 12, 2014

Conditions

Acne Vulgaris

Keywords

safetytolerabilitypharmacokineticsoral dosingmoderate to severe acne vulgaris

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability

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

    Weeks 2, 4, and 6

Secondary Outcomes (2)

  • Sebum measurements

    Weeks 2, 4, and 6

  • Pharmacokinetics of PF-05175157

    Weeks 2, 4, and 6

Study Arms (2)

PF-05175157

EXPERIMENTAL
Drug: PF-05175157

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

PF-05175157DRUG

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

PF-05175157
PlaceboDRUG

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

Placebo

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2014

First Posted

April 1, 2014

Study Start

April 1, 2014

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

May 13, 2014

Record last verified: 2014-05