Acne VulgarisPhase 2NCT00211497
Safety and Efficacy of MBI 226 1.25% and 2.5% Topical Acne Solutions in the Treatment of Acne
A Phase 2 study testing MBI 226 Acne Solutions in people with Acne Vulgaris and Acne, run by BioWest Therapeutics Inc.
Trial summary
This is a Phase II, randomized, vehicle-controlled, double-blind, multi center study to evaluate the efficacy and safety of topically applied MBI 226 1.25% and 2.5% Acne Solutions as anti-acne preparations in human subjects with facial acne vulgaris. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Acne Vulgaris, Acne, Propionibacterium Acnes
- What is being tested?
- MBI 226 Acne Solutions
- How many people
- 255 participants
- Where
- No sites listed yet
- Study dates
- Jan 2003to Sep 2003
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Males and females 12 years and older
- Presence of inflammatory and non-inflammatory lesions
Who cannot join
- Acne conglobata, acne fulminans, or secondary acne (chloracne, drug-induced acne, etc.)
- Active facial cysts or any nodulocystic lesions
About this study
Official title: A Phase II, Randomized, Vehicle-Controlled, Double-Blind, Multi-Center Study to Evaluate Safety and Efficacy of MBI 226 1.25% and 2.5% Acne Solutions Applied Topically for 12 Weeks to Subjects With Acne Vulgaris
This is a Phase II, randomized, vehicle-controlled, double-blind, multi center study to evaluate the efficacy and safety of topically applied MBI 226 1.25% and 2.5% Acne Solutions as anti-acne preparations in human subjects with facial acne vulgaris.
- Conditions
- Acne Vulgaris, Acne, Propionibacterium Acnes
- Being tested
- MBI 226 Acne Solutions
- Keywords
- acne vulgaris, acne, Propionibacterium acnes, topical, inflammatory, non-inflammatory, lesion counts, lesions
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBI 226 Acne SolutionsDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
- percent change from Baseline to Week 12 in inflammatory acne lesion counts
Secondary outcomes (11)
Single continuous endpoints:
• Percent change from Baseline to Week 6 and Week 12 in non inflammatory acne lesion counts
• The percent change from Baseline to Week 6 and Week 12 in total acne lesion counts
Multiple continuous endpoints:
• Percent change from Baseline to Weeks 3, 6, 9 and 12 in inflammatory acne lesion counts
• Percent change from Baseline to Weeks 3, 6, 9 and 12 in non-inflammatory acne lesion counts
• Percent change from Baseline to Weeks 3, 6, 9 and 12 in total acne lesion counts
Categorical endpoints:
• Dichotomized Physicians Global Severity Assessment scores at Week 6 and Week 12
• PGSA absolute scores at Week 6 and Week 12
• PGSA absolute scores over Baseline, Week 6 and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startJan 2003
- Study completionSep 2003
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.
- 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
- Enrolment
- 255 participants
Sponsor and investigators
- Lead sponsor
- BioWest Therapeutics Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jim Pankovich, Study director, BioWest Therapeutics Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00211497
- Sponsor's protocol ID
- A99005
- Status last verified
- Sep 2005
- First submitted
- 13 Sep 2005
- Last updated
- 21 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Vehicle-Controlled, Double-Blind, Multi-Center Study to Evaluate Safety and Efficacy of MBI 226 1.25% and 2.5% Acne Solutions Applied Topically for 12 Weeks to Subjects With Acne Vulgaris
- ClinicalTrials.gov ID
- NCT00211497
- Acronym / sponsor ID
- A99005
- Conditions
- Acne Vulgaris, Acne, Propionibacterium Acnes
- Keywords
- acne vulgaris, acne, Propionibacterium acnes, topical, inflammatory, non-inflammatory, lesion counts, lesions
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 255 participants
- Lead sponsor
- BioWest Therapeutics IncIndustry (pharma, biotech, devices)
- Study start
- Jan 2003
- Study completion
- Sep 2003
- First posted
- 21 Sep 2005 (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 Phase II, randomized, vehicle-controlled, double-blind, multi center study to evaluate the efficacy and safety of topically applied MBI 226 1.25% and 2.5% Acne Solutions as anti-acne preparations in human subjects with facial acne vulgaris.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Males and females 12 years and older
- Presence of inflammatory and non-inflammatory lesions
Key exclusion criteria (2 listed)
- Acne conglobata, acne fulminans, or secondary acne (chloracne, drug-induced acne, etc.)
- Active facial cysts or any nodulocystic lesions
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 |
|---|---|---|
| MBI 226 Acne Solutions | Drug | – |
Primary outcome
- percent change from Baseline to Week 12 in inflammatory acne lesion counts
11 secondary outcomes
Single continuous endpoints:
• Percent change from Baseline to Week 6 and Week 12 in non inflammatory acne lesion counts
• The percent change from Baseline to Week 6 and Week 12 in total acne lesion counts
Multiple continuous endpoints:
• Percent change from Baseline to Weeks 3, 6, 9 and 12 in inflammatory acne lesion counts
• Percent change from Baseline to Weeks 3, 6, 9 and 12 in non-inflammatory acne lesion counts
• Percent change from Baseline to Weeks 3, 6, 9 and 12 in total acne lesion counts
Categorical endpoints:
• Dichotomized Physicians Global Severity Assessment scores at Week 6 and Week 12
• PGSA absolute scores at Week 6 and Week 12
• PGSA absolute scores over Baseline, Week 6 and Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2005.
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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.
Jim Pankovich study director
BioWest Therapeutics Inc
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MBI 226 Acne Solutions in people with Acne Vulgaris and Acne, run by BioWest Therapeutics Inc.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 21 Sep 2005. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
- percent change from Baseline to Week 12 in inflammatory acne lesion counts. 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 21 Sep 2005.