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

Primary Purpose

Acne Vulgaris

Status

Withdrawn

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

PF-05175157

Placebo

About this trial

This is an interventional treatment trial for Acne Vulgaris focused on measuring safety, tolerability, pharmacokinetics, oral dosing, moderate to severe acne vulgaris

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

PF-05175157

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Safety and tolerability

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

Secondary Outcome Measures

Sebum measurements

Change from baseline in amount and rate of sebum excretion

Pharmacokinetics of PF-05175157

Plasma concentrations

Full Information

NCT ID

NCT02100527

First Posted

March 27, 2014

Last Updated

May 12, 2014

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT02100527

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2014

Overall Recruitment Status

Withdrawn

Why Stopped

Study canceled

Study Start Date

April 2014 (undefined)

Primary Completion Date

October 2014 (Anticipated)

Study Completion Date

October 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acne Vulgaris

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PF-05175157

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

PF-05175157

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Safety and tolerability

Description

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

Time Frame

Weeks 2, 4, and 6

Secondary Outcome Measure Information:

Title

Sebum measurements

Description

Change from baseline in amount and rate of sebum excretion

Time Frame

Weeks 2, 4, and 6

Title

Pharmacokinetics of PF-05175157

Description

Plasma concentrations

Time Frame

Weeks 2, 4, and 6

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

12. IPD Sharing Statement

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1731019&StudyName=Study%20Of%20Safety%2C%20Tolerability%20And%20Effects%20Of%20PF-05175157%20In%20Adults%20With%20Moderate%20To%20Severe%20Acne%20Vulgaris

Description

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Learn more about this trial

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

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