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

Last updated on December 17, 2017

FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Acne Vulgaris
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT02100527
Pfizer
Withdrawn
Study Of Safety, Tolerability And Effects Of PF-05175157 In Adults With Moderate To Severe Acne Vulgaris

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Study Of Safety, Tolerability And Effects Of PF-05175157 In Adults With Moderate To Severe Acne Vulgaris
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Acne Vulgaris
  • Drug: PF-05175157
    200 mg (as 2x100 mg tablets) twice a day (BID) for 6 weeks
  • Drug: Placebo
    placebo matching 200 mg (as 2x100 mg tablets) BID for 6 weeks
  • Experimental: PF-05175157
    Intervention: Drug: PF-05175157
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
October 2014
October 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Male
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT02100527
B1731019
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2014

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]



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