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

This study has been withdrawn prior to enrollment.
(Study canceled)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT02100527
First received: March 27, 2014
Last updated: May 12, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
Acne Vulgaris
Drug: PF-05175157
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Safety and tolerability [ Time Frame: Weeks 2, 4, and 6 ] [ Designated as safety issue: Yes ]
    Physical examination, pulmonary function testing, adverse event monitoring, ECGs, vital signs, laboratory tests


Secondary Outcome Measures:
  • Sebum measurements [ Time Frame: Weeks 2, 4, and 6 ] [ Designated as safety issue: No ]
    Change from baseline in amount and rate of sebum excretion

  • Pharmacokinetics of PF-05175157 [ Time Frame: Weeks 2, 4, and 6 ] [ Designated as safety issue: No ]
    Plasma concentrations


Enrollment: 0
Study Start Date: April 2014
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02100527

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

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02100527     History of Changes
Other Study ID Numbers: B1731019
Study First Received: March 27, 2014
Last Updated: May 12, 2014
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on July 23, 2014