Rosacea
Conditions
Keywords
Type 1 erythematotelangiectatic rosacea
Brief 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.
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.
Interventions
BIOLOGICALB244
B244 Suspension
BIOLOGICALVehicle
Vehicle suspension
Sponsors
bioRASI, LLC
AOBiome LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
This is a double blind study. Participants will be assigned to study treatment in accordance with the randomization schedule generated for the allocation of vehicle or B244 prior to the initiation of the trial. Randomization will be centrally-based and performed using an appropriate IWRS (an automated randomization system). Each participant scheduled to receive investigational product (IP) will receive a randomization number at the time of randomization. The randomization number will be used to identify the study medication kit assigned to the participant and indicate the treatment to be administered to that participant.
Intervention model description
Randomization will be 1:1 so that equal numbers of patients will be treated in each arm of the study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male and female subjects ≥18. 2. A clinical diagnosis of mild to moderate facial rosacea. 3. In good general health as determined by a thorough medical history, physical examination, clinical chemistry and hematology. 4. Presence of 3 to 20 inflammatory lesions on the face (i.e. papules/pustules). 5. A Clinician Erythema Assessment (CEA) score of 2-3 at Screening and at Baseline Visits (prior to the investigational product application). 6. Mild to Moderate IGA score of 2-3 at Screening and at Baseline Visits (prior to the investigational product application). 7. Willing to refrain from using any topical or systemic treatments for the treatment of rosacea, other than the investigational product. 8. Females of childbearing potential with a negative urine pregnancy test (UPT) at Screening and Baseline/Day 1 (prior to the investigational product application). 9. Ability to comprehend and comply with study procedures. 10. Agree to commit to participate in the current protocol. 11. Provide written informed consent prior to any study procedure being performed.
Exclusion criteria
1. Female subjects who are pregnant, lactating or who are trying to conceive will be excluded from participation in this study. 2. 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). 3. 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. 4. Presence of more than two (2) nodulocystic lesions on the face. 5. Presence of less than 3 and more than 20 inflammatory lesions on the face (i.e. papules/pustules). 6. Severe papulopustular rosacea requiring systemic treatment. 7. 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. 8. 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) 9. 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. 10. Carcinoid, Pheochromocytoma or other systemic causes of flushing. 11. Known sensitivity to B244 or its components. 12. Refusal to submit to blood and urine sampling for laboratory analysis. 13. Treatment with prohibited medications.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | Baseline to Day 84 | Safety and tolerability endpoints will consist of all treatment-related adverse events reporting during the study duration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Subjects With CEA Improvement at Week 8 Relative to Baseline. | Baseline to Day 56 | 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. |
| Change in IGA From Week 8 to Baseline. | Baseline to Day 56 | 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. |
| Proportion of Subjects With IGA Improvement at Week 8 Relative to Baseline. | Baseline to Day 56 | 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. |
| Change in Skindex 16 and Skindex 16 Sub Scores at Week 1, Week 4, Week 8 and Week 12 From Baseline. | Baseline to Day 84 | 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. |
| Proportion of Subjects With Change in PSA at Week 1, Week 4, Week 8 and Week 12 From Baseline. | Baseline to Day 84 | 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. |
| Change in CEA From Week 8 to Baseline. | Baseline to Day 56 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| B244 B244 suspension (4x10E9 cells/ml) in 30ml/bottle
Subjects will apply a total of 4 pumps of IP per application to the face twice-a-day.
B244: B244 Suspension | 73 |
| Vehicle Vehicle, 30ml/bottle
Subjects will apply a total of 4 pumps of IP per application to the face twice-a-day.
Vehicle: Vehicle suspension | 67 |
| Total | 140 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 3 |
| Overall Study | Lost to Follow-up | 3 | 3 |
| Overall Study | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | Vehicle | Total | B244 |
|---|---|---|---|
| Age, Continuous | 52.4 years STANDARD_DEVIATION 13.022 | 51.5 years STANDARD_DEVIATION 14.12 | 50.6 years STANDARD_DEVIATION 15.099 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 31 Participants | 62 Participants | 31 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 36 Participants | 78 Participants | 42 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 65 Participants | 137 Participants | 72 Participants |
| Sex: Female, Male Female | 48 Participants | 103 Participants | 55 Participants |
| Sex: Female, Male Male | 19 Participants | 37 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 73 | 0 / 67 |
| other Total, other adverse events | 19 / 73 | 12 / 67 |
| serious Total, serious adverse events | 0 / 73 | 0 / 67 |
Outcome results
Primary
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.
Time frame: Baseline to Day 84
Population: Modified Intent to Treat (mITT) Population, which included all subjects who all subjects who met all inclusion/exclusion criteria, were randomized, dispensed treatment, and had at least one post-treatment efficacy evaluation.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| B244 | Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | 5 Participants |
| Vehicle | Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | 6 Participants |
Secondary
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.
Time frame: Baseline to Day 56
Population: Modified Intent to Treat (mITT) Population, which included all subjects who all subjects who met all inclusion/exclusion criteria, were randomized, dispensed treatment, and had at least one post-treatment efficacy evaluation.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| B244 | Change in CEA From Week 8 to Baseline. | Week 8 1-Grade Change | 34 Participants |
| B244 | Change in CEA From Week 8 to Baseline. | Week 8 2-Grade Change | 14 Participants |
| B244 | Change in CEA From Week 8 to Baseline. | Week 8 3-Grade Change | 1 Participants |
| Vehicle | Change in CEA From Week 8 to Baseline. | Week 8 1-Grade Change | 27 Participants |
| Vehicle | Change in CEA From Week 8 to Baseline. | Week 8 2-Grade Change | 10 Participants |
| Vehicle | Change in CEA From Week 8 to Baseline. | Week 8 3-Grade Change | 1 Participants |
Secondary
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.
Time frame: Baseline to Day 56
Population: Modified Intent to Treat (mITT) Population, which included all subjects who all subjects who met all inclusion/exclusion criteria, were randomized, dispensed treatment, and had at least one post-treatment efficacy evaluation.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| B244 | Change in IGA From Week 8 to Baseline. | Week 8 1-Grade Change | 34 Participants |
| B244 | Change in IGA From Week 8 to Baseline. | Week 8 2-Grade Change | 14 Participants |
| B244 | Change in IGA From Week 8 to Baseline. | Week 8 3-Grade Change | 3 Participants |
| Vehicle | Change in IGA From Week 8 to Baseline. | Week 8 1-Grade Change | 26 Participants |
| Vehicle | Change in IGA From Week 8 to Baseline. | Week 8 2-Grade Change | 10 Participants |
| Vehicle | Change in IGA From Week 8 to Baseline. | Week 8 3-Grade Change | 2 Participants |
Secondary
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.
Time frame: Baseline to Day 84
Population: Subjects from modified Intent to Treat (mITT) Population (all subjects who all subjects who met all inclusion/exclusion criteria, were randomized, dispensed treatment, and had at least one post-treatment efficacy evaluation) that remained in the study at each respective time point for the outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| B244 | Change in Skindex 16 and Skindex 16 Sub Scores at Week 1, Week 4, Week 8 and Week 12 From Baseline. | Change from Baseline at Week 1 | -8.7 score on a scale | Standard Deviation 12.584 |
| B244 | Change in Skindex 16 and Skindex 16 Sub Scores at Week 1, Week 4, Week 8 and Week 12 From Baseline. | Change from Baseline at Week 4 | -14.5 score on a scale | Standard Deviation 13.908 |
| B244 | Change in Skindex 16 and Skindex 16 Sub Scores at Week 1, Week 4, Week 8 and Week 12 From Baseline. | Change from Baseline at Week 8 | -21.0 score on a scale | Standard Deviation 20.878 |
| B244 | Change in Skindex 16 and Skindex 16 Sub Scores at Week 1, Week 4, Week 8 and Week 12 From Baseline. | Change from Baseline at Week 12 (EOS) | -19.7 score on a scale | Standard Deviation 22.152 |
| Vehicle | Change in Skindex 16 and Skindex 16 Sub Scores at Week 1, Week 4, Week 8 and Week 12 From Baseline. | Change from Baseline at Week 12 (EOS) | -20.6 score on a scale | Standard Deviation 22.694 |
| Vehicle | Change in Skindex 16 and Skindex 16 Sub Scores at Week 1, Week 4, Week 8 and Week 12 From Baseline. | Change from Baseline at Week 1 | -12.4 score on a scale | Standard Deviation 17.111 |
| Vehicle | Change in Skindex 16 and Skindex 16 Sub Scores at Week 1, Week 4, Week 8 and Week 12 From Baseline. | Change from Baseline at Week 8 | -19.9 score on a scale | Standard Deviation 20.164 |
| Vehicle | Change in Skindex 16 and Skindex 16 Sub Scores at Week 1, Week 4, Week 8 and Week 12 From Baseline. | Change from Baseline at Week 4 | -18.4 score on a scale | Standard Deviation 17.418 |
Secondary
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.
Time frame: Baseline to Day 56
Population: Modified Intent to Treat (mITT) Population, which included all subjects who all subjects who met all inclusion/exclusion criteria, were randomized, dispensed treatment, and had at least one post-treatment efficacy evaluation.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| B244 | Proportion of Subjects With CEA Improvement at Week 8 Relative to Baseline. | 49 Participants |
| Vehicle | Proportion of Subjects With CEA Improvement at Week 8 Relative to Baseline. | 38 Participants |
Secondary
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.
Time frame: Baseline to Day 84
Population: Subjects from modified Intent to Treat (mITT) Population (all subjects who all subjects who met all inclusion/exclusion criteria, were randomized, dispensed treatment, and had at least one post-treatment efficacy evaluation) that remained in the study at each respective time point for the outcome measure.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| B244 | Proportion of Subjects With Change in PSA at Week 1, Week 4, Week 8 and Week 12 From Baseline. | Week 1 | 0-Grade Change | 49 Participants |
| B244 | Proportion of Subjects With Change in PSA at Week 1, Week 4, Week 8 and Week 12 From Baseline. | Week 1 | 1-Grade Change | 19 Participants |
| B244 | Proportion of Subjects With Change in PSA at Week 1, Week 4, Week 8 and Week 12 From Baseline. | Week 1 | 2-Grade Change | 5 Participants |
| B244 | Proportion of Subjects With Change in PSA at Week 1, Week 4, Week 8 and Week 12 From Baseline. | Week 1 | 3-Grade Change | 0 Participants |
| B244 | Proportion of Subjects With Change in PSA at Week 1, Week 4, Week 8 and Week 12 From Baseline. | Week 4 | 0-Grade Change | 29 Participants |
| B244 | Proportion of Subjects With Change in PSA at Week 1, Week 4, Week 8 and Week 12 From Baseline. | Week 4 | 1-Grade Change | 36 Participants |
| B244 | Proportion of Subjects With Change in PSA at Week 1, Week 4, Week 8 and Week 12 From Baseline. | Week 4 | 2-Grade Change | 5 Participants |
| B244 | Proportion of Subjects With Change in PSA at Week 1, Week 4, Week 8 and Week 12 From Baseline. | Week 4 | 3-Grade Change | 1 Participants |
| B244 | Proportion of Subjects With Change in PSA at Week 1, Week 4, Week 8 and Week 12 From Baseline. | Week 8 | 0-Grade Change | 23 Participants |
| B244 | Proportion of Subjects With Change in PSA at Week 1, Week 4, Week 8 and Week 12 From Baseline. | Week 8 | 1-Grade Change | 31 Participants |
| B244 | Proportion of Subjects With Change in PSA at Week 1, Week 4, Week 8 and Week 12 From Baseline. | Week 8 | 2-Grade Change | 14 Participants |
| B244 | Proportion of Subjects With Change in PSA at Week 1, Week 4, Week 8 and Week 12 From Baseline. | Week 8 | 3-Grade Change | 3 Participants |
| B244 | Proportion of Subjects With Change in PSA at Week 1, Week 4, Week 8 and Week 12 From Baseline. | Week 12 (EOS) | 0-Grade Change | 23 Participants |
| B244 | Proportion of Subjects With Change in PSA at Week 1, Week 4, Week 8 and Week 12 From Baseline. | Week 12 (EOS) | 1-Grade Change | 29 Participants |
| B244 | Proportion of Subjects With Change in PSA at Week 1, Week 4, Week 8 and Week 12 From Baseline. | Week 12 (EOS) | 2-Grade Change | 15 Participants |
| B244 | Proportion of Subjects With Change in PSA at Week 1, Week 4, Week 8 and Week 12 From Baseline. | Week 12 (EOS) | 3-Grade Change | 3 Participants |
| Vehicle | Proportion of Subjects With Change in PSA at Week 1, Week 4, Week 8 and Week 12 From Baseline. | Week 12 (EOS) | 3-Grade Change | 2 Participants |
| Vehicle | Proportion of Subjects With Change in PSA at Week 1, Week 4, Week 8 and Week 12 From Baseline. | Week 1 | 0-Grade Change | 44 Participants |
| Vehicle | Proportion of Subjects With Change in PSA at Week 1, Week 4, Week 8 and Week 12 From Baseline. | Week 8 | 0-Grade Change | 21 Participants |
| Vehicle | Proportion of Subjects With Change in PSA at Week 1, Week 4, Week 8 and Week 12 From Baseline. | Week 1 | 1-Grade Change | 19 Participants |
| Vehicle | Proportion of Subjects With Change in PSA at Week 1, Week 4, Week 8 and Week 12 From Baseline. | Week 12 (EOS) | 0-Grade Change | 22 Participants |
| Vehicle | Proportion of Subjects With Change in PSA at Week 1, Week 4, Week 8 and Week 12 From Baseline. | Week 1 | 2-Grade Change | 3 Participants |
| Vehicle | Proportion of Subjects With Change in PSA at Week 1, Week 4, Week 8 and Week 12 From Baseline. | Week 8 | 1-Grade Change | 24 Participants |
| Vehicle | Proportion of Subjects With Change in PSA at Week 1, Week 4, Week 8 and Week 12 From Baseline. | Week 1 | 3-Grade Change | 0 Participants |
| Vehicle | Proportion of Subjects With Change in PSA at Week 1, Week 4, Week 8 and Week 12 From Baseline. | Week 12 (EOS) | 2-Grade Change | 14 Participants |
| Vehicle | Proportion of Subjects With Change in PSA at Week 1, Week 4, Week 8 and Week 12 From Baseline. | Week 4 | 0-Grade Change | 23 Participants |
| Vehicle | Proportion of Subjects With Change in PSA at Week 1, Week 4, Week 8 and Week 12 From Baseline. | Week 8 | 2-Grade Change | 11 Participants |
| Vehicle | Proportion of Subjects With Change in PSA at Week 1, Week 4, Week 8 and Week 12 From Baseline. | Week 4 | 1-Grade Change | 30 Participants |
| Vehicle | Proportion of Subjects With Change in PSA at Week 1, Week 4, Week 8 and Week 12 From Baseline. | Week 12 (EOS) | 1-Grade Change | 21 Participants |
| Vehicle | Proportion of Subjects With Change in PSA at Week 1, Week 4, Week 8 and Week 12 From Baseline. | Week 4 | 2-Grade Change | 6 Participants |
| Vehicle | Proportion of Subjects With Change in PSA at Week 1, Week 4, Week 8 and Week 12 From Baseline. | Week 8 | 3-Grade Change | 3 Participants |
| Vehicle | Proportion of Subjects With Change in PSA at Week 1, Week 4, Week 8 and Week 12 From Baseline. | Week 4 | 3-Grade Change | 0 Participants |
Secondary
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.
Time frame: Baseline to Day 56
Population: Modified Intent to Treat (mITT) Population, which included all subjects who all subjects who met all inclusion/exclusion criteria, were randomized, dispensed treatment, and had at least one post-treatment efficacy evaluation.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| B244 | Proportion of Subjects With IGA Improvement at Week 8 Relative to Baseline. | 51 Participants |
| Vehicle | Proportion of Subjects With IGA Improvement at Week 8 Relative to Baseline. | 38 Participants |