Papulopustular RosaceaPhase 2PRISMNCT03667222
Topical Minocycline Gel for Inflammatory Lesions of Papulopustular Rosacea
A Phase 2 study testing minocycline topical gel in people with Papulopustular Rosacea, run by BioPharmX, Inc. at 12 sites in United States.
Trial summary
This is a 12-week, multicenter, double-blind, randomized, two-arm, vehicle controlled study. Subjects will be randomized 1:1 to BPX-04 minocycline topical gel 1% or vehicle. This study will include approximately 176 randomized subjects with inflammatory lesions of papulopustular rosacea on the face, defined by an IGA… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Papulopustular Rosacea
- What is being tested?
- minocycline topical gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 207 participants
- Where
- 12 sitesUnited States
- Study dates
- 18 Sep 2018to 17 Aug 2019
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects ≥18 years of age at the time of consent.
- Subjects do not have any medical conditions, other than rosacea, that in the opinion of the investigator, put the subject at unacceptable risk or could interfere with study assessments or integrity of the data.
- A clinical diagnosis of moderate to severe (Grade 3 or 4) facial rosacea (papulopustular (Subtype 2) or mixed erythematotelangiectatic (Subtype 1) and papulopustular (Subtype 2)) as determined by the Investigator's Global Assessment (IGA)
- Have 15-70 papulopustular lesions of rosacea on the face with no more than 2 nodules.
- Female subjects of childbearing potential are willing to use effective contraceptive method (s) for at least 4 weeks before Baseline and at least 4 weeks after the last study product administration or have a sterilized or same sex partner for the duration of the study. Effective contraceptive methods are: systemic hormonal contraceptives, intrauterine device or barrier method of contraception in conjunction with spermicide or agree to sexual abstinence. Hormonal contraceptives must be on a stable dose for at least 12 weeks before Baseline. Subjects using low dose (≤35 ug ethinyl estradiol) oral contraceptives must use a second form of birth control (e.g., barrier method such as condoms with spermicide).
- Female subjects of childbearing potential must have a negative urine pregnancy test (dipstick).
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- Subjects who use make-up, facial moisturizers, creams, lotions, cleansers and/or sunscreens must have used the same product brands/types for a minimum period of 2 weeks prior to Baseline, 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, lotions, cleansers and/or sunscreens on the scheduled clinic visit days before the visit.
- Be willing to limit or avoid known personal 'triggers' of rosacea such as spicy foods, consumption of alcoholic beverages, extended sun exposure, tanning beds, etc., for the duration of the study.
- Subjects must be capable of giving informed consent and the written informed consent must be obtained prior to any study-related procedures.
Who cannot join
- Have a history of skin disease, presence of skin condition, scarring or excessive facial hair the PI believes would interfere with the study.
- Have moderate or severe rhinophyma, severe telangiectasia or plaque-like facial edema.
- Have rosacea conglobata or fulminans, corticosteroid induced rosacea or facial erythrosis other than rosacea.
- Have ocular rosacea of a severity that requires systemic treatment.
- Have a history of any adverse reaction to minocycline or other tetracycline class antibiotic.
- Have a clinically significant chemistry or hematology value or have an ALT or AST that is greater than or equal to 2x normal.
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- Have any conditions or factors that the PI believes may affect the response of the skin or the interpretation of the results.
- Have a history of symptoms that might be confused with a diagnosis of pseudotumor cerebri such as severe headaches or visual disturbances inconsistent with a diagnosis of migraine or have a history of traumatic brain injury with headache and/or visual disturbances.
- Have used on the face an over the counter (OTC) topical medication for the treatment of rosacea within 4 weeks prior to Baseline.
- Have used prescription topical (on the face) and/or oral antibiotics within 4 weeks prior to Baseline.
- Treatment with hormonal therapy or oral corticosteroids that is not on a stable dose and frequency for at least 12 weeks before Baseline and not stable throughout the study.
- Have had a facial procedure such as chemical peel, laser, microdermabrasion or injections with a dermal filler or neuromodulator within 8 weeks prior to Baseline.
- Have received photodynamic therapy or phototherapy to the face within 12 weeks prior to Baseline.
- Have used an oral retinoid within 6 months or a topical retinoid within 3 months prior to Baseline.
- Current drug or alcohol abuse.
- Female subject who is breastfeeding, pregnant or who is planning a pregnancy during the study.
- Participated in any clinical study with exposure to any investigational treatment or product within the previous 4 weeks to Baseline, or plan on concurrent participation in other studies.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Study Center
Anaheim Hills, California, 92807
Study Center
Austin, Texas, 78759
Study Center
Baton Rouge, Louisiana, 70809
Study Center
High Point, North Carolina, 27262
Study Center
Miami, Florida, 33175
Study Center
Miramar, Florida, 33027
Study Center
Morristown, New Jersey, 07960
Study Center
Needham, Massachusetts, 02135
Study Center
New Orleans, Louisiana, 70115
Study Center
Philadelphia, Pennsylvania, 19103
Study Center
Saint Joseph, Missouri, 64506
Study Center
San Antonio, Texas, 78213
About this study
Official title: PRISM: A Double Blind, Randomized, Vehicle Controlled Phase 2 Study to Assess the Safety and Efficacy of BPX-04 Minocycline Topical Gel in the Treatment of Inflammatory Lesions of Papulopustular Rosacea
This is a 12-week, multicenter, double-blind, randomized, two-arm, vehicle controlled study. Subjects will be randomized 1:1 to BPX-04 minocycline topical gel 1% or vehicle. This study will include approximately 176 randomized subjects with inflammatory lesions of papulopustular rosacea on the face, defined by an IGA score of 3 (moderate) or 4 (severe) at Baseline. Subjects will be healthy male or female subjects aged 18 years or older. There will be up to 20 study sites in the USA.
Read the detailed description
This is a 12-week, multicenter, double-blind, randomized, two-arm, vehicle controlled study. Subjects will be randomized 1:1 to BPX-04 minocycline topical gel 1% or vehicle. This study will include approximately 176 randomized subjects with inflammatory lesions of papulopustular rosacea on the face, defined by an IGA score of 3 (moderate) or 4 (severe) at Baseline. Subjects will be healthy male or female subjects aged 18 years or older. There will be up to 20 study sites in the USA.
Subjects will apply approximately 1 gram of topical gel once each day for a 12 week duration. They will come to the study site at Screening, Baseline, and Weeks 4, 8, and 12 or early termination (ET) for the protocol required efficacy and safety evaluations.
At each visit, efficacy will be assessed by rosacea lesion counts, IGA, PGI-S, PGI-I, CGI-S, CGI-I, RosaQoL, Erythema Assessment Scale, Telangiectasia Assessment Scale and subject satisfaction questionnaire.
Safety will be assessed with vital signs, physical examination, laboratory tests such as clinical hematology and chemistries, investigators' and subjects' assessments of cutaneous tolerability, incidence of minocycline-induced skin hyperpigmentation, incidence of visual disturbances and/or headaches suggestive of pseudotumor cerebri, and incidence of TEAEs. Blood samples will be collected to evaluate the level of minocycline in plasma at Baseline and Week 12/ET.
- Conditions
- Papulopustular Rosacea
- Being tested
- minocycline topical gel, topical gel vehicle
- Medical subject headings
- Rosacea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
minocycline topical gelDrug
Once daily administration of BPX-04 minocycline gel for 12 weeks
topical gel vehicleDrug
Once daily administration of BPX-04 gel vehicle for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| BPX-04 Active | Experimental | BPX-04 1% minocycline topical gel Receives: Drug: minocycline topical gel |
| BPX-04 Vehicle | Placebo comparator | BPX-04 topical gel vehicle Receives: Drug: topical gel vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammatory lesion count
Change in mean facial inflammatory lesion count
Measured: Baseline to Week 12
Secondary outcomes (1)
Change in IGA
Proportion of subjects with ≥2-point change in IGA of rosacea to clear or almost clear
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2018
- Study start18 Sep 2018
- Primary completion17 May 2019
- Study completion17 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Papulopustular RosaceaStudies 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
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioPharmX, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- AnnaMarie Daniels, Study director, BioPharmX, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03667222
- Sponsor's protocol ID
- BPX-04-C07
- Acronym
- PRISM
- Status last verified
- Jul 2019
- First submitted
- 10 Sep 2018
- Last updated
- 10 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRISM: A Double Blind, Randomized, Vehicle Controlled Phase 2 Study to Assess the Safety and Efficacy of BPX-04 Minocycline Topical Gel in the Treatment of Inflammatory Lesions of Papulopustular Rosacea
- ClinicalTrials.gov ID
- NCT03667222
- Acronym / sponsor ID
- PRISM / BPX-04-C07
- Conditions
- Papulopustular Rosacea
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 207 participants (actual)
- Lead sponsor
- BioPharmX, Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Sep 2018 (actual)
- Primary completion
- 17 May 2019 (actual)
- Study completion
- 17 Aug 2019 (estimated)
- First posted
- 12 Sep 2018 (actual)
- 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, multicenter, double-blind, randomized, two-arm, vehicle controlled study. Subjects will be randomized 1:1 to BPX-04 minocycline topical gel 1% or vehicle. This study will include approximately 176 randomized subjects with inflammatory lesions of papulopustular rosacea on the face, defined by an IGA score of 3 (moderate) or 4 (severe) at Baseline. Subjects will be healthy male or female subjects aged 18 years or older. There will be up to 20 study sites in the USA.
Detailed description
This is a 12-week, multicenter, double-blind, randomized, two-arm, vehicle controlled study. Subjects will be randomized 1:1 to BPX-04 minocycline topical gel 1% or vehicle. This study will include approximately 176 randomized subjects with inflammatory lesions of papulopustular rosacea on the face, defined by an IGA score of 3 (moderate) or 4 (severe) at Baseline. Subjects will be healthy male or female subjects aged 18 years or older. There will be up to 20 study sites in the USA.
Subjects will apply approximately 1 gram of topical gel once each day for a 12 week duration. They will come to the study site at Screening, Baseline, and Weeks 4, 8, and 12 or early termination (ET) for the protocol required efficacy and safety evaluations.
At each visit, efficacy will be assessed by rosacea lesion counts, IGA, PGI-S, PGI-I, CGI-S, CGI-I, RosaQoL, Erythema Assessment Scale, Telangiectasia Assessment Scale and subject satisfaction questionnaire.
Safety will be assessed with vital signs, physical examination, laboratory tests such as clinical hematology and chemistries, investigators' and subjects' assessments of cutaneous tolerability, incidence of minocycline-induced skin hyperpigmentation, incidence of visual disturbances and/or headaches suggestive of pseudotumor cerebri, and incidence of TEAEs. Blood samples will be collected to evaluate the level of minocycline in plasma at Baseline and Week 12/ET.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BPX-04 Active | Experimental | Drug: minocycline topical gelBPX-04 1% minocycline topical gel |
| BPX-04 Vehicle | Placebo comparator | Drug: topical gel vehicleBPX-04 topical gel vehicle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female subjects ≥18 years of age at the time of consent.
- Subjects do not have any medical conditions, other than rosacea, that in the opinion of the investigator, put the subject at unacceptable risk or could interfere with study assessments or integrity of the data.
- A clinical diagnosis of moderate to severe (Grade 3 or 4) facial rosacea (papulopustular (Subtype 2) or mixed erythematotelangiectatic (Subtype 1) and papulopustular (Subtype 2)) as determined by the Investigator's Global Assessment (IGA)
- Have 15-70 papulopustular lesions of rosacea on the face with no more than 2 nodules.
- Female subjects of childbearing potential are willing to use effective contraceptive method (s) for at least 4 weeks before Baseline and at least 4 weeks after the last study product administration or have a sterilized or same sex partner for the duration of the study. Effective contraceptive methods are: systemic hormonal contraceptives, intrauterine device or barrier method of contraception in conjunction with spermicide or agree to sexual abstinence. Hormonal contraceptives must be on a stable dose for at least 12 weeks before Baseline. Subjects using low dose (≤35 ug ethinyl estradiol) oral contraceptives must use a second form of birth control (e.g., barrier method such as condoms with spermicide).
Key exclusion criteria (17 listed)
- Have a history of skin disease, presence of skin condition, scarring or excessive facial hair the PI believes would interfere with the study.
- Have moderate or severe rhinophyma, severe telangiectasia or plaque-like facial edema.
- Have rosacea conglobata or fulminans, corticosteroid induced rosacea or facial erythrosis other than rosacea.
- Have ocular rosacea of a severity that requires systemic treatment.
- Have a history of any adverse reaction to minocycline or other tetracycline class antibiotic.
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 |
|---|---|---|
| minocycline topical gelOnce daily administration of BPX-04 minocycline gel for 12 weeks | Drug | BPX-04 Active |
| topical gel vehicleOnce daily administration of BPX-04 gel vehicle for 12 weeks | Drug | BPX-04 Vehicle |
Primary outcome
Inflammatory lesion count
Time frame: Baseline to Week 12
Change in mean facial inflammatory lesion count
1 secondary outcome
Change in IGA
Time frame: Baseline to Week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2019.
- Individual participant dataSharing planned: No
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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.
AnnaMarie Daniels study director
BioPharmX, Inc.
12 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 minocycline topical gel in people with Papulopustular Rosacea, run by BioPharmX, Inc. at 12 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 9 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 10 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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?
Results are not available in the source record.
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?
Inflammatory 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 10 Jul 2019.