Study Of Safety, Tolerability And Effects Of PF-05175157 In Adults With Moderate To Severe Acne Vulgaris
- Registration Number
- NCT02100527
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Male
- Target Recruitment
- Not specified
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PF-05175157 PF-05175157 - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Safety and tolerability Weeks 2, 4, and 6 Physical examination, pulmonary function testing, adverse event monitoring, ECGs, vital signs, laboratory tests
- Secondary Outcome Measures
Name Time Method 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