Acne VulgarisPhase 2NCT02604680
A Safety and Efficacy Evaluation of Topical Treatments for Moderate-Severe Facial Acne Vulgaris
A Phase 2 study testing BLI1100-1, BLI1100-2 and BLI1100-3 in people with Acne Vulgaris, run by Braintree Laboratories at 50 sites in United States.
Trial summary
The objective of the study is to compare the safety and efficacy of multiple formulations of BLI1100 to a control group and placebo in treating patients with moderate-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?
- BLI1100-1, BLI1100-2 and BLI1100-3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 509 participants
- Where
- 50 sitesUnited States
- Study dates
- Oct 2015to Jun 2016
- 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, inclusive, in good general health.
- Clinical diagnosis of facial acne vulgaris
- Patients with an Investigator's Global Assessment severity score of at least 3 that meet the following lesion count criteria:
- A minimum of 20 but not more than 50 inflammatory lesions (including the nose)
- A minimum of 30 but not more than 100 non-inflammatory lesions on the face (including the nose)
- No nodules are allowed on the entire face.
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- Each patient or parent/guardian will read and sign the consent form as required by IRB regulations. Patients under the age of 18, but of sufficient age to provide assent (as determined by IRB regulations), will complete an assent form.
- Female patients of childbearing potential must have a negative urine pregnancy test prior to receiving study medication.
- Treatment with estrogens, androgens, or anti-androgenic agents for a non-contraceptive indication must be stable for 6 months prior to the first dose of study product and remain unchanged during the study.
- Patients who are willing and able to follow all study procedures, attend all scheduled visits, and successfully complete the study.
- Patients who are mentally competent in the Investigator's judgment, to provide informed consent/assent to participate in the study
Who cannot join
- Patients who had been treated with:
- systemic retinoids during a 6-month period before Visit 1 or by systemic antibiotics during a 4-week period before Visit 1
- or by a topical treatment (eg, antibiotics, benzoyl peroxide, retinoids, azelaic acid, resorcinol, salicylates, sulfacetamide sodium and derivatives, glycolic acid, dapsone) or systemic corticosteroids during a 2-week period before the first dose of study medication.
- History of hereditary angio-edema
- Pregnancy, lactation or patient, who is not practicing effective contraception.
- Any clinically relevant finding at their baseline physical examination or dermatological medical history such as severe systemic diseases or diseases of the facial skin.
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- A known endocrine malfunction (hyperthyroidism, hypothyroidism, diabetes, adrenal insufficiency).
- Erythroderma, immunodeficiency disorders and Mycosis Fungoides
- History of Epilepsy or Parkinson's disease
- History of alcohol and/or drug abuse within 5 years of screening
- Facial hair (beard), excessive scarring, sunburn or other disfigurement that may obscure the accurate assessment of acne grade
- Any single facial skin condition assessment graded as "Severe" at Visit 1
- Using drugs known to be photosensitizers because of the possibility of increased phototoxicity.
- Refusal to cease using the following types of facial products: astringents, toners, abradants, facials, loofahs, peels containing glycolic or other acids, masks, washes or soaps containing benzoyl peroxide (BPO), hydroquinone, sulfacetamide sodium or salicylic acid, non-mild facial cleansers, or moisturizers that contain retinol, salicylic acid, or α- or β-hydroxy acids .
- Using medications that are reported to exacerbate acne .
- Have had a facial procedure (chemical or laser peel, microdermabrasion, artificial ultraviolet therapy) performed by an esthetician, beautician, physician, nurse, or other practitioner, during the 4 weeks prior to Visit 1.
- Unwilling to avoid excessive swimming and sun exposure to include artificial UV light exposure (tanning beds).
- Patients using comedogenic makeup.
- Have a known hypersensitivity or previous allergic reaction to any of the components .
- Employees of the clinical research site or organization involved in the study, or an immediate family member (partner, offspring, parents, siblings, or sibling's offspring) of an employee.
- Have a member of the same household in this trial.
- 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
- Patients who withdraw consent before completion of Visit 1 procedures
Trial locations and contacts
50 sites in 1 country.
50 sites in 1 country
United States50 sites
BLI Research Site 30
Beaumont, Texas, 77701
BLI Research Site 34
Beverly, Massachusetts, 01915
BLI Research Site 27
Birmingham, Alabama, 35205
BLI Research Site 6
Bryan, Texas, 77802
BLI Research Site 57
Chula Vista, California, 91911
BLI Research Site 32
Cincinnati, Ohio, 45255
BLI Research Site 56
Costa Mesa, California, 92626
BLI Research Site 41
Denver, Colorado, 80220
BLI Research Site 18
Encino, California, 91436
BLI Research Site 37
Fort Gratiot, Michigan, 48059
BLI Research Site 7
Fremont, California, 94538
BLI Research Site 53
Goodlettsville, Tennessee, 37072
BLI Research Site 4
Gresham, Oregon, 97030
BLI Research Site 19
Hialeah, Florida, 33012
BLI Research Site 50
High Point, North Carolina, 27262
BLI Research Site 3
Houston, Texas, 77056
BLI Research Site 10
Johnston, Rhode Island, 02919
BLI Research Site 49
Jupiter, Florida, 33458
BLI Research Site 33
Louisville, Kentucky, 40202
BLI Research Site 12
Miami, Florida, 33126
BLI Research Site 54
Miami Lakes, Florida, 33016
BLI Research Site 24
Mobile, Alabama, 36608
BLI Research Site 58
Murfreesboro, Tennessee, 37130
BLI Research Site 14
Nashville, Tennessee, 37203
BLI Research Site 8
New Braunfels, Texas, 78130
BLI Research Site 5
Newington, New Hampshire, 03801
BLI Research Site 26
Norfolk, Virginia, 23507
BLI Research Site 55
Norman, Oklahoma, 73071
BLI Research Site 9
Omaha, Nebraska, 68114
BLI Research Site 47
Omaha, Nebraska, 68144
BLI Research Site 20
Ormond Beach, Florida, 32174
BLI Research Site 44
Pflugerville, Texas, 78660
BLI Research Site 60
Philadelphia, Pennsylvania, 19103
BLI Research Site 11
Plainfield, Indiana, 46168
BLI Research Site 59
Port Saint Lucie, Florida, 34984
BLI Research Site 42
Quincy, Massachusetts, 02169
BLI Research Site 40
Rogers, Arkansas, 72758
BLI Research Site 21
Salt Lake City, Utah, 84117
BLI Research Site 16
San Antonio, Texas, 78249
BLI Research Site 25
Spokane, Washington, 99202
BLI Research Site 15
St. Petersburg, Florida, 33709
BLI Research Site 46
Stony Brook, New York, 11790
BLI Research Site 1
Tampa, Florida, 33607
BLI Research Site 29
Tampa, Florida, 33609
BLI Research Site 51
Tucson, Arizona, 85745
BLI Research Site 45
Upland, California, 91786
BLI Research Site 28
Wellington, Florida, 33414
BLI Research Site 43
West Palm Beach, Florida, 33406
BLI Research Site 39
Wheat Ridge, Colorado, 80033
BLI Research Site 52
Wilmington, North Carolina, 28401
About this study
Official title: A Randomized, Controlled Evaluation of the Safety and Efficacy of Topical Treatments for Moderate-Severe Facial Acne Vulgaris
The objective of the study is to compare the safety and efficacy of multiple formulations of BLI1100 to a control group and placebo in treating patients with moderate-severe acne vulgaris.
- Conditions
- Acne Vulgaris
- Being tested
- BLI1100-1, BLI1100-2, BLI1100-3, BLI1100-4, 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.
BLI1100-1Drug
BLI1100-1 Topical gel
BLI1100-2Drug
BLI1100-2 Topical gel
BLI1100-3Drug
BLI1100-3 Topical gel
BLI1100-4Drug
BLI1100-4 Topical gel
PlaceboDrug
Placebo - Topical gel
| Study group | Role | What they receive |
|---|---|---|
| BLI1100-1 | Experimental | Topical gel Receives: Drug: BLI1100-1 |
| BLI1100-2 | Experimental | Topical gel Receives: Drug: BLI1100-2 |
| BLI1100-3 | Experimental | Topical gel Receives: Drug: BLI1100-3 |
| BLI1100-4 | Experimental | Topical gel Receives: Drug: BLI1100-4 |
| Placebo | Placebo comparator | Topical gel Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute change in total lesion count
Measured: 12 weeks
Treatment success based on Investigator Global Assessment
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 posted13 Nov 2015 (estimated)
- Study startOct 2015
- Primary completionJun 2016
- Study completionJun 2016
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 509 participants (actual)
Sponsor and investigators
- Lead sponsor
- Braintree Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John McGowan, Study director, Braintree Laboratories, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02604680
- Sponsor's protocol ID
- BLI1100-203
- Status last verified
- Jul 2017
- First submitted
- 12 Nov 2015
- Last updated
- 28 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Evaluation of the Safety and Efficacy of Topical Treatments for Moderate-Severe Facial Acne Vulgaris
- ClinicalTrials.gov ID
- NCT02604680
- Acronym / sponsor ID
- BLI1100-203
- Conditions
- Acne Vulgaris
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 509 participants (actual)
- Lead sponsor
- Braintree LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- Oct 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 13 Nov 2015 (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 objective of the study is to compare the safety and efficacy of multiple formulations of BLI1100 to a control group and placebo in treating patients with moderate-severe acne vulgaris.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| BLI1100-1 | Experimental | Drug: BLI1100-1Topical gel |
| BLI1100-2 | Experimental | Drug: BLI1100-2Topical gel |
| BLI1100-3 | Experimental | Drug: BLI1100-3Topical gel |
| BLI1100-4 | Experimental | Drug: BLI1100-4Topical gel |
| Placebo | Placebo comparator | Drug: PlaceboTopical gel |
Who may qualify
- Ages
- 12 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- Males or females 12 to 45 years of age, inclusive, in good general health.
- Clinical diagnosis of facial acne vulgaris
- Patients with an Investigator's Global Assessment severity score of at least 3 that meet the following lesion count criteria:
- Each patient or parent/guardian will read and sign the consent form as required by IRB regulations. Patients under the age of 18, but of sufficient age to provide assent (as determined by IRB regulations), will complete an assent form.
- Female patients of childbearing potential must have a negative urine pregnancy test prior to receiving study medication.
Key exclusion criteria (24 listed)
- Patients who had been treated with:
- History of hereditary angio-edema
- Pregnancy, lactation or patient, who is not practicing effective contraception.
- Any clinically relevant finding at their baseline physical examination or dermatological medical history such as severe systemic diseases or diseases of the facial skin.
- A known endocrine malfunction (hyperthyroidism, hypothyroidism, diabetes, adrenal insufficiency).
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 |
|---|---|---|
| BLI1100-1BLI1100-1 Topical gel | Drug | BLI1100-1 |
| BLI1100-2BLI1100-2 Topical gel | Drug | BLI1100-2 |
| BLI1100-3BLI1100-3 Topical gel | Drug | BLI1100-3 |
| BLI1100-4BLI1100-4 Topical gel | Drug | BLI1100-4 |
| PlaceboPlacebo - Topical gel | Drug | Placebo |
Primary outcome
Absolute change in total lesion count
Time frame: 12 weeks
Treatment success based on Investigator Global Assessment
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 28 Jul 2017.
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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 study director
Braintree Laboratories, Inc.
50 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 BLI1100-1, BLI1100-2 and BLI1100-3 in people with Acne Vulgaris, run by Braintree Laboratories at 50 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 11 inclusion and 24 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 28 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 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?
Absolute change in total lesion count (time frame: 12 weeks). The study lists 2 primary outcomes in all. 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 28 Jul 2017.