Acne VulgarisPhase 2OPALNCT02815332
BPX-01 Minocycline Topical Gel in the Treatment of Acne Vulgaris
A Phase 2 study testing BPX-01 1% Minocycline Topical Gel and BPX-01 2% Minocycline Topical Gel in people with Acne Vulgaris, run by BioPharmX, Inc. at 15 sites in United States.
Trial summary
This is a 12-week, multi-center, double-blind, randomized, three-arm, vehicle-controlled study. Subjects will be randomized (1:1:1) to 1% or 2 % BPX-01 gel, or vehicle. Subjects will apply 1g of the gel as a thin film to the entire face at least 30 minutes before bedtime each night for 12 weeks. Read more about this study
- Who is it for?
- Ages 9 to 40 years
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- BPX-01 1% Minocycline Topical Gel and BPX-01 2% Minocycline Topical Gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 225 participants
- Where
- 15 sitesUnited States
- Study dates
- Aug 2016to 24 Mar 2017
- 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 9 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male or female subjects aged between 9 and 40 years of age.
- Subjects do not have any medical conditions, other than acne vulgaris, that in the opinion of the investigator, put the subject at unacceptable risk or could interfere with study assessments or integrity of the data.
- Moderate to severe inflammatory non-nodular acne vulgaris.
- Female subjects of childbearing potential (including pre-puberty) are willing to use effective contraceptive method for at least 28 days before baseline (Day 0) and at least 28 days after the last study product administration or have a sterilized or same-sex partner for the duration of the study.
- Treatment with hormonal therapy must be on a stable dose and frequency for at least 12 weeks before baseline (Day 0) and must remain stable throughout the study.
- Subjects who use make-up, facial moisturizers, creams, or lotions, cleansers and/or sunscreens must have used the same product brands/types for a minimum period of 14 days prior to baseline (Day 0), must agree not to change brand/type or frequency of use throughout the study and must agree not to use make-up, facial moisturizers, creams, or lotions, cleansers and/or sunscreens on the clinic visit days before the visit.
- Subjects must be capable of giving informed consent and the written informed consent must be obtained prior to any study-related procedures. Subject under 18 years of age must sign an assent form, and their parent(s) or legal representative must have read and signed the informed consent form prior to any study-related procedures.
Who cannot join
- Female subject who is breastfeeding, pregnant or who is planning a pregnancy during the study.
- Have acne fulminans or conglobata, or nodulocystic acne.
- Have a history of skin disease, presence of skin condition, or excessive facial hair that, in the opinion of the investigator, would interfere with the study.
- Have a history of cancer or lymphoproliferative disease other than a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix.
- Have a history of minocycline-induced hepatitis, minocycline-induced arthritis, minocycline-induced lupus or minocycline/tetracycline-induced pseudotumor cerebri.
- Presence of minocycline-induced hyperpigmentation at screening or baseline (Day 0).
Show all 22Show fewer
- Presence of visual disturbances and/or headaches suggestive of pseudotumor cerebri at screening or baseline (Day 0).
- Have a clinical chemistry or hematology laboratory value that is abnormal at the screening visit and that is considered clinically significant by the investigator.
- Has an ALT or AST at screening greater than or equal to 2 times the upper limit of normal.
- Have used on the face an over-the-counter (OTC) topical medications for the treatment of acne vulgaris including benzoyl peroxide, topical anti-inflammatory medications, corticosteroids, salicylic acid, α-hydroxy/glycolic, antibacterial/antiseptic soap or wash within 14 days prior to baseline (Day 0).
- Have used prescription topical retinoid (e.g. tretinoin, tazarotene, adapalene) or antimicrobials (e.g. clindamycin, erythromycin) or other prescription topical medications for the treatment of acne vulgaris within 28 days of baseline (Day 0).
- Have used systemic antibiotics or other systemic anti-acne drugs not mentioned in the exclusion criteria within 28 days of baseline (Day 0).
- Have used oral, intranasal, or injectable corticosteroids within 28 days of baseline (Day 0) or require them during the study. Inhaled corticosteroids for stable medical conditions are allowed.
- Have received an investigational therapy (including investigational drug or procedure) within 28 days of baseline (Day 0) or plan to use one during the study.
- Have had a facial procedure (e.g. chemical peel, laser, microdermabrasion) within 8 weeks of baseline (Day 0).
- Have excessive sun exposure, is planning a trip to a sunny climate or used tanning booths within 28 days prior to baseline (Day 0) or is not willing to minimize natural and artificial sunlight exposure during the study.
- Have received photodynamic therapy or phototherapy with blue or red light within 12 weeks of baseline (Day 0).
- Have used androgen receptor blockers (such as spironolactone or flutamide) within 12 weeks of baseline (Day 0).
- Have used drospirenone, chlormadinone acetate, and cyproterone acetate within 26 weeks of baseline (Day 0).
- Have used oral retinoid (e.g., isotretinoin) within 52 weeks prior to baseline (Day 0) or vitamin A supplements greater than 10,000 U/d within 26 weeks of baseline (Day 0).
- History of clinically significant drug or alcohol abuse in the last year prior to baseline (Day 0) as judged by the investigator.
- Has known or suspected allergy to minocycline, tetracycline-class antibiotics or any component of the investigational product.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Study site
Coral Gables, Florida
Study site
Highpoint, North Carolina
Study site
Lake Mary, Florida
Study site
Las Vegas, Nevada
Study site
Louisville, Kentucky
Study site
Montclair, New Jersey
Study site
Murfreesboro, Tennessee
Study site
Nashville, Tennessee
Study site
New York, New York
Study site
Newnan, Georgia
Study site
Pflugerville, Texas
Study site
Plano, Texas
Study site
San Antonio, Texas
Study site
Santa Monica, California
Study site
Spokane, Washington
About this study
Official title: A Randomized, Double-blind, Vehicle Controlled Study to Assess the Safety and Efficacy of BPX-01 Minocycline Topical Gel in the Treatment of Moderate to Severe Inflammatory Acne Vulgaris
This is a 12-week, multi-center, double-blind, randomized, three-arm, vehicle-controlled study.
Subjects will be randomized (1:1:1) to 1% or 2 % BPX-01 gel, or vehicle. Subjects will apply 1g of the gel as a thin film to the entire face at least 30 minutes before bedtime each night for 12 weeks. Lesion counts, IGA, and Patient-Reported Outcomes (PGI-S and PGI-I) will be performed to assess efficacy.
Blood draws will be collected at baseline (Day 0), and at Weeks 4 and 12 to evaluate the level of minocycline in plasma. Safety will be assessed with the vital signs, brief physical examination, clinical laboratory tests, cutaneous tolerance score, incidence of minocycline-induced skin hyperpigmentation, incidence of visual disturbances and/or headaches suggestive of pseudotumor cerebri, and collection of adverse events.
Read the detailed description
This is a phase 2b, randomized, double-blind, vehicle-controlled study to Assess the Safety and Efficacy of BPX-01 Minocycline Topical Gel in the Treatment of Moderate to Severe Inflammatory Acne Vulgaris.
Study Population: Approximately 225 male or female subjects aged between 9 and 40 years with moderate to severe inflammatory non-nodular acne vulgaris will be included in this study.
Number of Sites: Approximately 15 centers from the United States will participate in this study.
Study Duration: Overall study duration is expected to be approximately 24 weeks (6 months). The study duration for individual subjects is approximately 16 weeks (including the screening period).
Hypothesis: BPX-01 improves disease condition in subjects with moderate to severe inflammatory non-nodular acne vulgaris compared with vehicle.
Objectives:
Primary:
- To evaluate the efficacy of BPX-01 minocycline 1% or 2% topical gel in the treatment of inflammatory non-nodular acne vulgaris
Secondary:
- To evaluate the plasma level of minocycline after once daily application of 1% or 2% BPX 01 topical gel
- To evaluate the safety of BPX-01 minocycline 1% or 2% topical gel
Endpoints:
Primary Efficacy Endpoint:
- Absolute mean change from baseline in inflammatory lesion counts at Week 12
Secondary Efficacy Endpoint:
- Proportion of subjects with at least a two-grade reduction in IGA at Week 12
- Conditions
- Acne Vulgaris
- Being tested
- BPX-01 1% Minocycline Topical Gel, BPX-01 2% Minocycline Topical Gel, BPX-01 Vehicle Topical Gel
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BPX-01 1% Minocycline Topical GelDrug
Also called BPX-01 Topical Gel
Approximately 1 gram applied once daily for 12 weeks
BPX-01 2% Minocycline Topical GelDrug
Also called BPX-01 Topical Gel
Approximately 1 gram applied once daily for 12 weeks
BPX-01 Vehicle Topical GelDrug
Also called BPX-01 Vehicle Gel
Approximately 1 gram applied once daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| BPX-01 Vehicle Topical Gel | Placebo comparator | Approximately 1 gram applied once daily for 12 weeks Receives: Drug: BPX-01 Vehicle Topical Gel |
| BPX-01 1% Minocycline Topical Gel | Experimental | Approximately 1 gram applied once daily for 12 weeks Receives: Drug: BPX-01 1% Minocycline Topical Gel |
| BPX-01 2% Minocycline Topical Gel | Experimental | Approximately 1 gram applied once daily for 12 weeks Receives: Drug: BPX-01 2% Minocycline Topical Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in inflammatory lesion counts
Absolute mean change from baseline in inflammatory lesion counts
Measured: 12 weeks
Secondary outcomes (1)
Reduction in IGA
Proportion of subjects with at least a two-grade reduction in IGA from baseline
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 posted28 Jun 2016 (estimated)
- Study startAug 2016
- Primary completion24 Mar 2017
- Study completion24 Mar 2017
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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioPharmX, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- AnnaMarie Daniels, Study director, Sponsor (BioPharmX)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02815332
- Sponsor's protocol ID
- BPX-01-C03
- Acronym
- OPAL
- Status last verified
- Apr 2017
- First submitted
- 24 Jun 2016
- Last updated
- 14 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Vehicle Controlled Study to Assess the Safety and Efficacy of BPX-01 Minocycline Topical Gel in the Treatment of Moderate to Severe Inflammatory Acne Vulgaris
- ClinicalTrials.gov ID
- NCT02815332
- Acronym / sponsor ID
- OPAL / BPX-01-C03
- Conditions
- Acne Vulgaris
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- BioPharmX, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2016
- Primary completion
- 24 Mar 2017 (actual)
- Study completion
- 24 Mar 2017 (actual)
- First posted
- 28 Jun 2016 (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 12-week, multi-center, double-blind, randomized, three-arm, vehicle-controlled study.
Subjects will be randomized (1:1:1) to 1% or 2 % BPX-01 gel, or vehicle. Subjects will apply 1g of the gel as a thin film to the entire face at least 30 minutes before bedtime each night for 12 weeks. Lesion counts, IGA, and Patient-Reported Outcomes (PGI-S and PGI-I) will be performed to assess efficacy.
Blood draws will be collected at baseline (Day 0), and at Weeks 4 and 12 to evaluate the level of minocycline in plasma. Safety will be assessed with the vital signs, brief physical examination, clinical laboratory tests, cutaneous tolerance score, incidence of minocycline-induced skin hyperpigmentation, incidence of visual disturbances and/or headaches suggestive of pseudotumor cerebri, and collection of adverse events.
Detailed description
This is a phase 2b, randomized, double-blind, vehicle-controlled study to Assess the Safety and Efficacy of BPX-01 Minocycline Topical Gel in the Treatment of Moderate to Severe Inflammatory Acne Vulgaris.
Study Population: Approximately 225 male or female subjects aged between 9 and 40 years with moderate to severe inflammatory non-nodular acne vulgaris will be included in this study.
Number of Sites: Approximately 15 centers from the United States will participate in this study.
Study Duration: Overall study duration is expected to be approximately 24 weeks (6 months). The study duration for individual subjects is approximately 16 weeks (including the screening period).
Hypothesis: BPX-01 improves disease condition in subjects with moderate to severe inflammatory non-nodular acne vulgaris compared with vehicle.
Objectives:
Primary:
- To evaluate the efficacy of BPX-01 minocycline 1% or 2% topical gel in the treatment of inflammatory non-nodular acne vulgaris
Secondary:
- To evaluate the plasma level of minocycline after once daily application of 1% or 2% BPX 01 topical gel
- To evaluate the safety of BPX-01 minocycline 1% or 2% topical gel
Endpoints:
Primary Efficacy Endpoint:
- Absolute mean change from baseline in inflammatory lesion counts at Week 12
Secondary Efficacy Endpoint:
- Proportion of subjects with at least a two-grade reduction in IGA at Week 12
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BPX-01 Vehicle Topical Gel | Placebo comparator | Drug: BPX-01 Vehicle Topical GelApproximately 1 gram applied once daily for 12 weeks |
| BPX-01 1% Minocycline Topical Gel | Experimental | Drug: BPX-01 1% Minocycline Topical GelApproximately 1 gram applied once daily for 12 weeks |
| BPX-01 2% Minocycline Topical Gel | Experimental | Drug: BPX-01 2% Minocycline Topical GelApproximately 1 gram applied once daily for 12 weeks |
Who may qualify
- Ages
- 9 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Male or female subjects aged between 9 and 40 years of age.
- Subjects do not have any medical conditions, other than acne vulgaris, that in the opinion of the investigator, put the subject at unacceptable risk or could interfere with study assessments or integrity of the data.
- Moderate to severe inflammatory non-nodular acne vulgaris.
- Female subjects of childbearing potential (including pre-puberty) are willing to use effective contraceptive method for at least 28 days before baseline (Day 0) and at least 28 days after the last study product administration or have a sterilized or same-sex partner for the duration of the study.
- Treatment with hormonal therapy must be on a stable dose and frequency for at least 12 weeks before baseline (Day 0) and must remain stable throughout the study.
Key exclusion criteria (22 listed)
- Female subject who is breastfeeding, pregnant or who is planning a pregnancy during the study.
- Have acne fulminans or conglobata, or nodulocystic acne.
- Have a history of skin disease, presence of skin condition, or excessive facial hair that, in the opinion of the investigator, would interfere with the study.
- Have a history of cancer or lymphoproliferative disease other than a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix.
- Have a history of minocycline-induced hepatitis, minocycline-induced arthritis, minocycline-induced lupus or minocycline/tetracycline-induced pseudotumor cerebri.
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 |
|---|---|---|
| BPX-01 1% Minocycline Topical GelAlso: BPX-01 Topical GelApproximately 1 gram applied once daily for 12 weeks | Drug | BPX-01 1% Minocycline Topical Gel |
| BPX-01 2% Minocycline Topical GelAlso: BPX-01 Topical GelApproximately 1 gram applied once daily for 12 weeks | Drug | BPX-01 2% Minocycline Topical Gel |
| BPX-01 Vehicle Topical GelAlso: BPX-01 Vehicle GelApproximately 1 gram applied once daily for 12 weeks | Drug | BPX-01 Vehicle Topical Gel |
Primary outcome
Change in inflammatory lesion counts
Time frame: 12 weeks
Absolute mean change from baseline in inflammatory lesion counts
1 secondary outcome
Reduction in IGA
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 14 Apr 2017.
- Individual participant dataSharing planned: Yes
Related trials for Acne Vulgaris
Not yet recruitingPhase 3
Evaluation of the Efficacy and Safety of Fractional CO₂ Laser With and Without Intradermal Botulinum Toxin A in the Treatment of Inflammatory Facial Acne Vulgaris.
Acne, Acne Papulopustulosa
RecruitingPhase 4
Safety, Tolerability, and Clinical Effectiveness of Adapalene/Clindamycin Phosphate Gel (Klenzit®-C) in Vietnamese Patients With Mild to Moderate Acne Vulgaris
Acne
RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
Acne Vulgaris
RecruitingPhase 4
Comparing Nadifloxacin Plus Tretinoin Versus Clindamycin Plus Tretinoin Creams for Mild-to-Moderate Acne
Acne Vulgaris
Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
Hair Reduction, Tattoo Removal
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.
AnnaMarie Daniels study director
Sponsor (BioPharmX)
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 BPX-01 1% Minocycline Topical Gel and BPX-01 2% Minocycline Topical Gel in people with Acne Vulgaris, run by BioPharmX, Inc. 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 7 inclusion and 22 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 14 Apr 2017. 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 inflammatory lesion counts (time frame: 12 weeks). 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 14 Apr 2017.