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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02100527
Recruitment Status : Withdrawn (Study canceled)
First Posted : April 1, 2014
Last Update Posted : May 13, 2014
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: PF-05175157 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : April 2014
Estimated Primary Completion Date : October 2014
Estimated Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne
U.S. FDA Resources

Arm Intervention/treatment
Experimental: PF-05175157 Drug: PF-05175157
200 mg (as 2x100 mg tablets) twice a day (BID) for 6 weeks
Placebo Comparator: Placebo Drug: Placebo
placebo matching 200 mg (as 2x100 mg tablets) BID for 6 weeks



Primary Outcome Measures :
  1. Safety and tolerability [ Time Frame: Weeks 2, 4, and 6 ]
    Physical examination, pulmonary function testing, adverse event monitoring, ECGs, vital signs, laboratory tests


Secondary Outcome Measures :
  1. Sebum measurements [ Time Frame: Weeks 2, 4, and 6 ]
    Change from baseline in amount and rate of sebum excretion

  2. Pharmacokinetics of PF-05175157 [ Time Frame: Weeks 2, 4, and 6 ]
    Plasma concentrations



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02100527


Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02100527     History of Changes
Other Study ID Numbers: B1731019
First Posted: April 1, 2014    Key Record Dates
Last Update Posted: May 13, 2014
Last Verified: May 2014

Keywords provided by Pfizer:
safety
tolerability
pharmacokinetics
oral dosing
moderate to severe acne vulgaris

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases