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

Pfizer

Status and phase: Withdrawn; Phase 2

Conditions: Acne Vulgaris

Treatments: Drug: PF-05175157; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02100527

B1731019

Details and patient eligibility

About

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.

Sex: Male

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups, including a placebo group

PF-05175157

Experimental group

Treatment:

Drug: PF-05175157

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo