RosaceaPhase 2NCT03590366
A Study to Determine Safety and Efficacy of B244 in Subjects With Mild to Moderate Rosacea
A Phase 2 study testing B244 in people with Rosacea, run by AOBiome LLC at 9 sites in United States.
Trial summary
This is a Prospective, Vehicle Controlled, Double Blind, Multicenter, Randomized Phase II trial, comparing the effect of twice daily B244 application for 8 weeks vs. vehicle application on treatment of mild to moderate rosacea. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rosacea
- What is being tested?
- B244
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 9 sitesUnited States
- Study dates
- 2 Jul 2018to 5 Mar 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 and female subjects ≥18.
- A clinical diagnosis of mild to moderate facial rosacea.
- In good general health as determined by a thorough medical history, physical examination, clinical chemistry and hematology.
- Presence of 3 to 20 inflammatory lesions on the face (i.e. papules/pustules).
- A Clinician Erythema Assessment (CEA) score of 2-3 at Screening and at Baseline Visits (prior to the investigational product application).
- Mild to Moderate IGA score of 2-3 at Screening and at Baseline Visits (prior to the investigational product application).
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- Willing to refrain from using any topical or systemic treatments for the treatment of rosacea, other than the investigational product.
- Females of childbearing potential with a negative urine pregnancy test (UPT) at Screening and Baseline/Day 1 (prior to the investigational product application).
- Ability to comprehend and comply with study procedures.
- Agree to commit to participate in the current protocol.
- Provide written informed consent prior to any study procedure being performed.
Who cannot join
- Female subjects who are pregnant, lactating or who are trying to conceive will be excluded from participation in this study.
- Any uncontrolled chronic or serious disease or medical condition that would normally prevent participation in a clinical trial, or, in the judgment of the Investigator, would put the subject at undue risk, or might confound the study assessments (e.g., other dermatological diseases), or might interfere with the subject's participation in the study, (e.g., planned hospitalization during the study).
- Particular forms of rosacea (e.g., rosacea conglobata, rosacea fulminans, isolated rhinophyma, isolated pustulosis of the chin, Ocular rosacea Phymatous rosacea, Steroid-induced rosacea, severe rosacea including pyoderma faciale) or other concomitant facial dermatoses that are similar to rosacea such as peri-oral dermatitis, demodicidosis, facial keratosis pilaris, seborrheic dermatitis, acute lupus erythematosus, or actinic telangiectasia.
- Presence of more than two (2) nodulocystic lesions on the face.
- Presence of less than 3 and more than 20 inflammatory lesions on the face (i.e. papules/pustules).
- Severe papulopustular rosacea requiring systemic treatment.
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- Participation at the time of eligibility assessment (Screening) in any other investigational drug or device study or may have participated within 30 days prior to Screening.
- Commencement of new hormonal therapy or dose change to hormonal therapy within 30 days prior to baseline. Dose and frequency of use of any hormonal therapy started more than 30 days prior to baseline must remain unchanged throughout the study. Hormonal therapies include, but are not limited to, oral, injected or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS) or other forms of hormonal contraception that have comparable efficacy (e.g. vaginal ring or transdermal hormone contraception)
- Presence of beard or excessive facial hair at Screening which would interfere with the study treatments or study assessments and refusal to remove for duration of study.
- Carcinoid, Pheochromocytoma or other systemic causes of flushing.
- Known sensitivity to B244 or its components.
- Refusal to submit to blood and urine sampling for laboratory analysis.
- Treatment with prohibited medications.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Tampa Bay Medical Research
Clearwater, Florida, 33761
West Houston Clinical Research Service
Houston, Texas, 77055
Veritas Research Corp
Miami, Florida, 33126
South Coast Research Center, Inc.
Miami, Florida, 33136
FXM Research Corp.
Miami, Florida, 33175
FXM Research Miramar
Miramar, Florida, 33027
Paddington Testing Co.
Philadelphia, Pennsylvania, 19103
Wake Research Associates, LLC
Raleigh, North Carolina, 27612
Omega Medical Research
Warwick, Rhode Island, 02886
About this study
Official title: A Vehicle-Controlled, Double-Blind, Randomized Phase II Study of B244 Delivered as a Topical Spray to Determine Safety and Efficacy in Subjects With Mild to Moderate Rosacea
This is a Prospective, Vehicle Controlled, Double Blind, Multicenter, Randomized Phase II trial, comparing the effect of twice daily B244 application for 8 weeks vs. vehicle application on treatment of mild to moderate rosacea.
Read the detailed description
This is a Prospective, Vehicle Controlled, Double Blind, Multicenter, Randomized Phase II trial, comparing the effect of twice daily B244 application for 8 weeks vs. vehicle application on treatment of mild to moderate rosacea.
At Screening and Baseline all subjects must have Type 1 erythematotelangiectatic rosacea (ETR).
The total duration of the study will be approximately 12 weeks. Participants will report for a Screening visit and if all inclusion criteria are met will undergo a washout period, between 2 days and 4 weeks, depending on current treatment. Subjects will then report for the Baseline visit.
Subjects will come in for visits at Day 7 (Week 1), Day 28 (Week 4), and Day 56 (Week 8). A final visit will be conducted at Day 84 (Week 12).
Efficacy will be assessed using Clinician Erythema Assessment (CEA), Investigator Global Assessment (IGA), Skindex16, and Patient Self-Assessment (PSA).
Blood and urine samples will be collected for standard safety laboratory tests. Participant's safety will be monitored throughout the study.
Investigators plan to enroll approximately 130 subjects.
Randomization will be 1:1 so that equal numbers of subjects will be treated in each arm of the study.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B244Biological
B244 Suspension
VehicleBiological
Vehicle suspension
| Study group | Role | What they receive |
|---|---|---|
| B244 | Active comparator | B244 suspension in 30ml/bottle
Subjects will apply a total of 4 pumps of IP per application to the face twice-a-day. Receives: Biological: B244 |
| Vehicle | Placebo comparator | Vehicle, 30ml/bottle
Subjects will apply a total of 4 pumps of IP per application to the face twice-a-day. Receives: Biological: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
Safety and tolerability endpoints will consist of all treatment-related adverse events reporting during the study duration.
Measured: Baseline to Day 84
Secondary outcomes (6)
Proportion of Subjects With IGA Improvement at Week 8 Relative to Baseline.
IGA (Investigator's Global Assessment) was used to assess the overall diseases severity on a scale of 0 to 4 (0=clear, 1=almost clear, 2=mild disease, 3=moderate disease, and 4=severe disease). Improvement is defined as at least 1-grade change.
Measured: Baseline to Day 56
Proportion of Subjects With CEA Improvement at Week 8 Relative to Baseline.
Clinical Erythema Assessment (CEA) was used to assess the extent of rosacea on a scale of 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe). Improvement is defined as at least 1-grade change.
Measured: Baseline to Day 56
Change in IGA From Week 8 to Baseline.
IGA (Investigator's Global Assessment) was used to assess the overall diseases severity on a scale of 0 to 4 (0=clear, 1=almost clear, 2=mild disease, 3=moderate disease, and 4=severe disease). A higher grade change indicates greater improvement in disease.
Measured: Baseline to Day 56
Change in CEA From Week 8 to Baseline.
Clinical Erythema Assessment (CEA) was used to assess the extent of rosacea on a scale of 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe). A higher grade change indicates greater improvement in disease.
Measured: Baseline to Day 56
Change in Skindex 16 and Skindex 16 Sub Scores at Week 1, Week 4, Week 8 and Week 12 From Baseline.
The Skindex 16 questionnaire was assigned to subjects to examine the relationship between the subject's skin health and quality of life. Subjects scored 16 questions from 0 to 6 (0=never bothered, 6=always bothered). Total scores could range between 0 to 96, where a higher score is associated with a worse quality of life.
Measured: Baseline to Day 84
Proportion of Subjects With Change in PSA at Week 1, Week 4, Week 8 and Week 12 From Baseline.
Subjects were asked to perform static ("snap-shot") evaluations of their rosacea-associated facial erythema severity using the Patient Self Assessment scale (PSA) at each study visit, and report the one integer that best describes the overall severity of their facial redness as seen in a mirror at the time of the evaluation on a scale of 0 to 4 (0=no redness, 1=very mild redness, 2=mild redness, 3=moderate redness, 4=severe redness). A higher grade change indicates greater improvement.
Measured: Baseline to Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2018
- Study start2 Jul 2018
- Primary completion11 Feb 2019
- Study completion5 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for 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
- Model description
- Randomization will be 1:1 so that equal numbers of patients will be treated in each arm of the study.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- AOBiome LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- bioRASI, LLC
- Responsible party
- Sponsor
- Investigators
- Judith Ng-Cashin, MD, Study director, Chief Medical OfficerSpiros Jamas, ScD, Study director, AOBiome Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03590366
- Sponsor's protocol ID
- RB244-001
- Status last verified
- Aug 2022
- First submitted
- 25 Jun 2018
- Last updated
- 16 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Vehicle-Controlled, Double-Blind, Randomized Phase II Study of B244 Delivered as a Topical Spray to Determine Safety and Efficacy in Subjects With Mild to Moderate Rosacea
- ClinicalTrials.gov ID
- NCT03590366
- Acronym / sponsor ID
- RB244-001
- Conditions
- Rosacea
- Keywords
- Type 1 erythematotelangiectatic rosacea
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- AOBiome LLCIndustry (pharma, biotech, devices)
- Collaborators
- bioRASI, LLC
- Study start
- 2 Jul 2018 (actual)
- Primary completion
- 11 Feb 2019 (actual)
- Study completion
- 5 Mar 2019 (actual)
- First posted
- 18 Jul 2018 (actual)
- Results
- Posted 16 Sep 2022
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 Prospective, Vehicle Controlled, Double Blind, Multicenter, Randomized Phase II trial, comparing the effect of twice daily B244 application for 8 weeks vs. vehicle application on treatment of mild to moderate rosacea.
Detailed description
This is a Prospective, Vehicle Controlled, Double Blind, Multicenter, Randomized Phase II trial, comparing the effect of twice daily B244 application for 8 weeks vs. vehicle application on treatment of mild to moderate rosacea.
At Screening and Baseline all subjects must have Type 1 erythematotelangiectatic rosacea (ETR).
The total duration of the study will be approximately 12 weeks. Participants will report for a Screening visit and if all inclusion criteria are met will undergo a washout period, between 2 days and 4 weeks, depending on current treatment. Subjects will then report for the Baseline visit.
Subjects will come in for visits at Day 7 (Week 1), Day 28 (Week 4), and Day 56 (Week 8). A final visit will be conducted at Day 84 (Week 12).
Efficacy will be assessed using Clinician Erythema Assessment (CEA), Investigator Global Assessment (IGA), Skindex16, and Patient Self-Assessment (PSA).
Blood and urine samples will be collected for standard safety laboratory tests. Participant's safety will be monitored throughout the study.
Investigators plan to enroll approximately 130 subjects.
Randomization will be 1:1 so that equal numbers of subjects will be treated in each arm of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomization will be 1:1 so that equal numbers of patients will be treated in each arm of the study.
| Arm | Type | Receives |
|---|---|---|
| B244 | Active comparator | Biological: B244B244 suspension in 30ml/bottle Subjects will apply a total of 4 pumps of IP per application to the face twice-a-day. |
| Vehicle | Placebo comparator | Biological: VehicleVehicle, 30ml/bottle Subjects will apply a total of 4 pumps of IP per application to the face twice-a-day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male and female subjects ≥18.
- A clinical diagnosis of mild to moderate facial rosacea.
- In good general health as determined by a thorough medical history, physical examination, clinical chemistry and hematology.
- Presence of 3 to 20 inflammatory lesions on the face (i.e. papules/pustules).
- A Clinician Erythema Assessment (CEA) score of 2-3 at Screening and at Baseline Visits (prior to the investigational product application).
Key exclusion criteria (13 listed)
- Female subjects who are pregnant, lactating or who are trying to conceive will be excluded from participation in this study.
- Any uncontrolled chronic or serious disease or medical condition that would normally prevent participation in a clinical trial, or, in the judgment of the Investigator, would put the subject at undue risk, or might confound the study assessments (e.g., other dermatological diseases), or might interfere with the subject's participation in the study, (e.g., planned hospitalization during the study).
- Particular forms of rosacea (e.g., rosacea conglobata, rosacea fulminans, isolated rhinophyma, isolated pustulosis of the chin, Ocular rosacea Phymatous rosacea, Steroid-induced rosacea, severe rosacea including pyoderma faciale) or other concomitant facial dermatoses that are similar to rosacea such as peri-oral dermatitis, demodicidosis, facial keratosis pilaris, seborrheic dermatitis, acute lupus erythematosus, or actinic telangiectasia.
- Presence of more than two (2) nodulocystic lesions on the face.
- Presence of less than 3 and more than 20 inflammatory lesions on the face (i.e. papules/pustules).
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 |
|---|---|---|
| B244B244 Suspension | Biological | B244 |
| VehicleVehicle suspension | Biological | Vehicle |
Primary outcome
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
Time frame: Baseline to Day 84
Safety and tolerability endpoints will consist of all treatment-related adverse events reporting during the study duration.
6 secondary outcomes
Proportion of Subjects With IGA Improvement at Week 8 Relative to Baseline.
Time frame: Baseline to Day 56
Proportion of Subjects With CEA Improvement at Week 8 Relative to Baseline.
Time frame: Baseline to Day 56
Change in IGA From Week 8 to Baseline.
Time frame: Baseline to Day 56
Change in CEA From Week 8 to Baseline.
Time frame: Baseline to Day 56
Change in Skindex 16 and Skindex 16 Sub Scores at Week 1, Week 4, Week 8 and Week 12 From Baseline.
Time frame: Baseline to Day 84
Proportion of Subjects With Change in PSA at Week 1, Week 4, Week 8 and Week 12 From Baseline.
Time frame: Baseline to Day 84
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Judith Ng-Cashin, MD study director
Chief Medical Officer
Spiros Jamas, ScD study director
AOBiome Therapeutics
9 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 B244 in people with Rosacea, run by AOBiome LLC at 9 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 13 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 16 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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?
Yes. Results are posted in the registry (first posted 16 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 (time frame: Baseline to Day 84). 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 16 Sep 2022.