Acne VulgarisPhase 2NCT01815450
BLI1100-202: BLI1100 for the Treatment of Moderate to Severe Acne Vulgaris
A Phase 2 study testing BLI1100 and BLI1100 - modified formulation in people with Acne Vulgaris, run by Braintree Laboratories at 15 sites in United States.
Trial summary
The purpose of this study is to compare the safety and efficacy of BLI1100 formulations to placebo for the treatment of moderate to severe acne vulgaris. Read more about this study
- Who is it for?
- Ages 12 to 45 years
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- BLI1100 and BLI1100 - modified formulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 369 participants
- Where
- 15 sitesUnited States
- Study dates
- Feb 2013to Nov 2013
- 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 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Males or females 12 to 45 years of age with facial acne vulgaris
- Qualifying Investigator's Global Assessment severity score
- Qualifying number of non-inflammatory lesions
- Qualifying number of inflammatory lesions
Who cannot join
- Facial hair (beard), excessive scarring, sunburn or other disfigurement that may obscure the accurate assessment of acne grade
- Using medications that are reported to exacerbate acne
- Any clinically relevant finding at their baseline physical examination or dermatological medical history such as severe systemic diseases or diseases of the facial skin
- Have a known hypersensitivity or previous allergic reaction to any of the components
- Patients who have participated in an investigational clinical, surgical, drug, or device study within the past 30 days
- Patients who, in the opinion of the investigator, should not be included in the study for any reason, including inability to follow study procedures
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Academic Dermatology Associates
Albuquerque, New Mexico, 87106
Peachtree Dermatology Associates Research Center
Atlanta, Georgia, 30327
Great Lakes Research Group, Inc.
Bay City, Michigan, 48706
DiscoveResearch
Bryan, Texas, 77802
Center for Dermatology Clincal Research
Fremont, California, 94538
Minnesota Clinical Study Center
Fridley, Minnesota, 55432
Suzanne Bruce and Associates
Houston, Texas, 77056
North Florida Dermatology Associates
Jacksonville, Florida, 32204
Clinical Partners
Johnston, Rhode Island, 02919
The Education and Research Foundation
Lynchburg, Virginia, 24501
Ameriderm Research
Ormond Beach, Florida, 32174
The Indiana Clinical Trials Center
Plainfield, Indiana, 46168
Dermatology Research Center
Salt Lake City, Utah, 84124
Women's Clinical Research Center
Seattle, Washington, 98105
Premier Clinical Research
Spokane, Washington, 99204
About this study
The purpose of this study is to compare the safety and efficacy of BLI1100 formulations to placebo for the treatment of moderate to severe acne vulgaris.
- Conditions
- Acne Vulgaris
- Being tested
- BLI1100, BLI1100 - modified formulation, Placebo
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BLI1100Drug
BLI1100 topical cream
BLI1100 - modified formulationDrug
BLI1100 topical cream
PlaceboDrug
Placebo topical cream
| Study group | Role | What they receive |
|---|---|---|
| BLI1100 | Experimental | BLI1100 topical cream Receives: Drug: BLI1100 |
| BLI1100 - modified formulation | Experimental | BLI1100 topical cream Receives: Drug: BLI1100 - modified formulation |
| Placebo | Placebo comparator | Topical cream Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in total lesion count
Measured: Baseline to Week 12
Secondary outcomes (3)
Percent change in total lesion count
Measured: Baseline to Week 12
Investigator's Global Assessment
Rating of overall facial acne on a 5 point scale (0=clear, 4 = severe)
Measured: 12 weeks
Local Tolerability Score
Rating of facial symptoms on a 4 point scale (0=none, 3=severe)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2013 (estimated)
- Study startFeb 2013
- Primary completionNov 2013
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
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 369 participants (actual)
Sponsor and investigators
- Lead sponsor
- Braintree Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John McGowan, MPH, Study director, Braintree Laboratories, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01815450
- Sponsor's protocol ID
- BLI1100-202
- Status last verified
- Jan 2015
- First submitted
- 18 Mar 2013
- Last updated
- 2 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BLI1100-202: BLI1100 for the Treatment of Moderate to Severe Acne Vulgaris
- ClinicalTrials.gov ID
- NCT01815450
- Acronym / sponsor ID
- BLI1100-202
- Conditions
- Acne Vulgaris
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 369 participants (actual)
- Lead sponsor
- Braintree LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Nov 2013 (actual)
- First posted
- 21 Mar 2013 (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.
The purpose of this study is to compare the safety and efficacy of BLI1100 formulations to placebo for the treatment of moderate to severe acne vulgaris.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BLI1100 | Experimental | Drug: BLI1100BLI1100 topical cream |
| BLI1100 - modified formulation | Experimental | Drug: BLI1100 - modified formulationBLI1100 topical cream |
| Placebo | Placebo comparator | Drug: PlaceboTopical cream |
Who may qualify
- Ages
- 12 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Males or females 12 to 45 years of age with facial acne vulgaris
- Qualifying Investigator's Global Assessment severity score
- Qualifying number of non-inflammatory lesions
- Qualifying number of inflammatory lesions
Key exclusion criteria (6 listed)
- Facial hair (beard), excessive scarring, sunburn or other disfigurement that may obscure the accurate assessment of acne grade
- Using medications that are reported to exacerbate acne
- Any clinically relevant finding at their baseline physical examination or dermatological medical history such as severe systemic diseases or diseases of the facial skin
- Have a known hypersensitivity or previous allergic reaction to any of the components
- Patients who have participated in an investigational clinical, surgical, drug, or device study within the past 30 days
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 |
|---|---|---|
| BLI1100BLI1100 topical cream | Drug | BLI1100 |
| BLI1100 - modified formulationBLI1100 topical cream | Drug | BLI1100 - modified formulation |
| PlaceboPlacebo topical cream | Drug | Placebo |
Primary outcome
Change in total lesion count
Time frame: Baseline to Week 12
3 secondary outcomes
Percent change in total lesion count
Time frame: Baseline to Week 12
Investigator's Global Assessment
Time frame: 12 weeks
Local Tolerability Score
Time frame: 12 weeks
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 2 Feb 2015.
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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.
John McGowan, MPH study director
Braintree Laboratories, Inc.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BLI1100 and BLI1100 - modified formulation in people with Acne Vulgaris, run by Braintree Laboratories at 15 sites in United States.
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 6 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 2 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 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?
Change in total lesion count (time frame: Baseline to Week 12). 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 2 Feb 2015.