- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02100527
Study Of Safety, Tolerability And Effects Of PF-05175157 In Adults With Moderate To Severe Acne Vulgaris
May 12, 2014 updated by: Pfizer
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.
Study Overview
Study Type
Interventional
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
placebo matching 200 mg (as 2x100 mg tablets) BID for 6 weeks
|
Experimental: PF-05175157
|
200 mg (as 2x100 mg tablets) twice a day (BID) for 6 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety and tolerability
Time Frame: Weeks 2, 4, and 6
|
Physical examination, pulmonary function testing, adverse event monitoring, ECGs, vital signs, laboratory tests
|
Weeks 2, 4, and 6
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sebum measurements
Time Frame: Weeks 2, 4, and 6
|
Change from baseline in amount and rate of sebum excretion
|
Weeks 2, 4, and 6
|
Pharmacokinetics of PF-05175157
Time Frame: Weeks 2, 4, and 6
|
Plasma concentrations
|
Weeks 2, 4, and 6
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2014
Primary Completion (Anticipated)
October 1, 2014
Study Completion (Anticipated)
October 1, 2014
Study Registration Dates
First Submitted
March 27, 2014
First Submitted That Met QC Criteria
March 31, 2014
First Posted (Estimate)
April 1, 2014
Study Record Updates
Last Update Posted (Estimate)
May 13, 2014
Last Update Submitted That Met QC Criteria
May 12, 2014
Last Verified
May 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B1731019
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Acne Vulgaris
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Nexgen Dermatologics, Inc.Unknown
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PollogenLumenis Be Ltd.RecruitingModerate to Severe Acne VulgarisUnited States
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Boston PharmaceuticalsCompletedModerate to Severe Acne VulgarisUnited States, Canada
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Bispebjerg HospitalCompleted
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Actavis Mid-Atlantic LLCCompletedMILD TO SEVERE ACNE VULGARISIndia
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