Acne VulgarisPhase 2NCT02100527
Study Of Safety, Tolerability And Effects Of PF-05175157 In Adults With Moderate To Severe Acne Vulgaris
A Phase 2 study testing PF-05175157 in people with Acne Vulgaris, run by Pfizer.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- PF-05175157
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2014to Oct 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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
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.
- Conditions
- Acne Vulgaris
- Being tested
- PF-05175157, Placebo
- Keywords
- safety, tolerability, pharmacokinetics, oral dosing, moderate to severe acne vulgaris
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-05175157Drug
200 mg (as 2x100 mg tablets) twice a day (BID) for 6 weeks
PlaceboDrug
placebo matching 200 mg (as 2x100 mg tablets) BID for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| PF-05175157 | Experimental | Not described Receives: Drug: PF-05175157 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability
Physical examination, pulmonary function testing, adverse event monitoring, ECGs, vital signs, laboratory tests
Measured: Weeks 2, 4, and 6
Secondary outcomes (2)
Sebum measurements
Change from baseline in amount and rate of sebum excretion
Measured: Weeks 2, 4, and 6
Pharmacokinetics of PF-05175157
Plasma concentrations
Measured: Weeks 2, 4, and 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionOct 2014 (estimated)
- Study completionOct 2014 (estimated)
Why it stopped: Study canceled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02100527
- Sponsor's protocol ID
- B1731019
- Status last verified
- May 2014
- First submitted
- 27 Mar 2014
- Last updated
- 13 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02100527
- Acronym / sponsor ID
- B1731019
- Conditions
- Acne Vulgaris
- Keywords
- safety, tolerability, pharmacokinetics, oral dosing, moderate to severe acne vulgaris
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study canceled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- Oct 2014 (estimated)
- Study completion
- Oct 2014 (estimated)
- First posted
- 1 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PF-05175157 | Experimental | Drug: PF-05175157 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PF-05175157200 mg (as 2x100 mg tablets) twice a day (BID) for 6 weeks | Drug | PF-05175157 |
| Placeboplacebo matching 200 mg (as 2x100 mg tablets) BID for 6 weeks | Drug | Placebo |
Primary outcome
Safety and tolerability
Time frame: Weeks 2, 4, and 6
Physical examination, pulmonary function testing, adverse event monitoring, ECGs, vital signs, laboratory tests
2 secondary outcomes
Sebum measurements
Time frame: Weeks 2, 4, and 6
Pharmacokinetics of PF-05175157
Time frame: Weeks 2, 4, and 6
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2014.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PF-05175157 in people with Acne Vulgaris, run by Pfizer.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 May 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability (time frame: Weeks 2, 4, and 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2014.