Acne Vulgaris
Conditions
Brief summary
The purpose of this study is to demonstrate the safety, tolerability and efficacy of B244 administered over 12 weeks to participants with mild to moderate acne vulgaris relative to placebo.
Detailed description
This is a Phase IIb/III, randomized, double blinded, decentralized clinical trial evaluating the safety, tolerability, and efficacy of B244 compared to placebo in the treatment of acne vulgaris 1.1. Primary Objectives 1. To evaluate the safety and tolerability of B244 in participants with acne vulgaris 2. To assess the efficacy of B244 in participants with mild to moderate acne vulgaris from baseline to week 12 (end of treatment) by: i) Reduction in inflammatory and non-inflammatory lesion count ii) IGA success 3. Improvement in patient reported quality of life score using the Skindex-16 questionnaire in participants with acne vulgaris from baseline to week 12 1.2. Secondary Objectives 1. To evaluate the efficacy of B244 in participants with mild to moderate acne vulgaris from baseline to weeks 2, 4, 8, and 16: i) Reduction in inflammatory and non-inflammatory lesion count ii) IGA success iii) Improvement in patient reported quality of life score using the Skindex-16 questionnaire 1.3. Exploratory Objective 1\. To evaluate facial skin microbiota in participants with acne vulgaris at baseline, week 4, week 8, week 12, and week 16 in B244-treated participants compared to placebo from: i) Skin swabs will be taken from forehead, nose, both cheeks and chin All participants (placebo and B244) will undergo skin swabs and testing.
Interventions
BIOLOGICALB244
4 pumps of spray to saturate the entire face applied BID. Applications should occur in the morning and at night for 12 weeks.
BIOLOGICALPlacebo
4 pumps of spray to saturate the entire face applied BID. Applications should occur in the morning and at night for 12 weeks.
Sponsors
AOBiome LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participants eligible for enrollment in the study must meet all the following criteria: 1. Male and females age 18 or older 2. Clinical diagnosis of mild to moderate facial acne vulgaris defined as: 1. ≥5 inflammatory lesions, and; 2. ≥10 non-inflammatory lesions, and; 3. IGA 2-3 3. Willing to refrain from using any treatments, other than the investigational product, for acne present on the face. This includes the use of antibiotics for the treatment of acne. Topical acne treatments that do not have significant or measurable systemic absorption (e.g., benzoyl peroxide, salicylic acid) are allowed for treatment of non-facial acne. 4. Willing and able to provide informed consent and to comply with the study protocol.
Exclusion criteria
1. Pregnant and/or lactating females 2. Continuous or planned use of tanning booths or excessive sun exposure, in the opinion of the Investigator. 3. Active cystic acne or acne conglobata, acne fulminans, and secondary acne 4. Two or more active nodular lesions 5. Treatment with over-the-counter topical medications for the treatment of acne vulgaris including benzoyl peroxide, topical anti-inflammatory medications, corticosteroids, α-hydroxy/glycolic acid, or topical probiotics including commercially available product AO+Mist on the face within 7 days prior to baseline. 6. Treatment with systemic corticosteroids within 28 days prior to baseline. 7. Treatment with systemic antibiotics or systemic anti-acne drugs within 7 days prior to baseline. 8. Prescription topical retinoid use on the face within 7 days of baseline (e.g., tretinoin, tazarotene, adapalene). 9. Commencement of new hormonal therapy or dose change to hormonal therapy within 90 days prior to baseline. Dose and frequency of use of any hormonal therapy started more than 90 days prior to baseline must remain unchanged throughout the study. Hormonal therapies include, but are not limited to, estrogenic and progestational agents such as birth control pills. 10. Use of androgen receptor blockers (such as spironolactone or flutamide) in the 7 days prior to randomization. 11. Oral retinoid use (e.g., isotretinoin) within 180 days prior to baseline or vitamin A supplements greater than 10,000 units/day within 180 days of baseline. 12. Cosmetic facial procedures (chemical or laser peel, microdermabrasion, etc.) within the 28 days of the first dose or during the study. 13. History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the Investigator or Medical Monitor, contraindicates their participation. 14. Any condition that the study Investigator feels would indicate that participation would not be in the best interest of the participant. 15. The participant has been previously randomized in this study. 16. The participant has received an investigational product within 30 days or 5 half-lives, whichever is longer prior to randomization.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Demonstrating Efficacy Measured by Investigator Global Assessment Success | 12 weeks | 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). IGA success was defined as a post-baseline score of 0 or 1 (yes=success, no=no success). |
| Number of Participants With Treatment RelatedAdverse Events | 16 weeks | Safety and tolerability endpoints will consist of all treatment related adverse events reporting during the study duration. |
| Change in Inflammatory and Non-inflammatory Lesion Count | 12 weeks | Lesion counting was performed using the digital photos taken by participants and stored inside the study mobile platform by trained personnel only. Every effort was made to have the counting and clinical evaluation done by the same evaluator for a given participant. Lesions under the jaw line or behind the hairline (including eyebrows) were not included in the counts. Papules, pustules, cysts and nodules were classified as inflammatory acne lesions, and open and closed comedones were classified as non-inflammatory lesions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Patient Reported Quality of Life Score Using the Skindex-16 Questionnaire | Baseline to weeks 2, 4, 8, 12 and 16 | 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. |
| Change in Inflammatory and Non-inflammatory Lesion Count by Week | Baseline to weeks 2, 4, 8, 12 and 16 | Lesion counting was performed using the digital photos taken by participants and stored inside the study mobile platform by trained personnel only. Every effort was made to have the counting and clinical evaluation done by the same evaluator for a given participant. Lesions under the jaw line or behind the hairline (including eyebrows) were not included in the counts. Papules, pustules, cysts and nodules were classified as inflammatory acne lesions, and open and closed comedones were classified as non-inflammatory lesions. |
| Number of Participants Demonstrating Efficacy Measured Investigator Global Assessment Score by Week | Baseline to weeks 2, 4, 8, 12 and 16 | 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). IGA success was defined as a post-baseline score of 0 or 1 (yes=success, no=no success). |
Other
| Measure | Time frame | Description |
|---|---|---|
| To Evaluate Facial Skin Microbiota | baseline, week 4, week 8, week 12, and week 16 | Evaluate if B244 administration on skin twice daily will affect the microbial content on collected skin swab samples. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| B244 Arm B244 dose (4x10E9 cells/mL) administered in a 1:1 (active vs placebo) ratio
B244: 4 pumps of spray to saturate the entire face applied BID. Applications should occur in the morning and at night for 12 weeks. | 181 |
| Placebo Arm Placebo dose administered in a 1:1 (active vs placebo) ratio
Placebo: 4 pumps of spray to saturate the entire face applied BID. Applications should occur in the morning and at night for 12 weeks. | 179 |
| Total | 360 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 1 |
| Overall Study | Lost to Follow-up | 15 | 8 |
| Overall Study | Other | 2 | 1 |
| Overall Study | Physician Decision | 5 | 7 |
| Overall Study | Withdrawal by Subject | 10 | 21 |
Baseline characteristics
| Characteristic | B244 Arm | Placebo Arm | Total |
|---|---|---|---|
| Age, Customized 18 to <30 years | 126 Participants | 122 Participants | 248 Participants |
| Age, Customized 30 to <65 years | 55 Participants | 57 Participants | 112 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 39 Participants | 37 Participants | 76 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 137 Participants | 141 Participants | 278 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 5 Participants | 1 Participants | 6 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 27 Participants | 21 Participants | 48 Participants |
| Race (NIH/OMB) Black or African American | 19 Participants | 9 Participants | 28 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 | 28 Participants | 16 Participants | 44 Participants |
| Race (NIH/OMB) White | 107 Participants | 133 Participants | 240 Participants |
| Sex: Female, Male Female | 95 Participants | 92 Participants | 187 Participants |
| Sex: Female, Male Male | 86 Participants | 87 Participants | 173 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 181 | 0 / 179 |
| other Total, other adverse events | 39 / 181 | 42 / 179 |
| serious Total, serious adverse events | 3 / 181 | 2 / 179 |
Outcome results
Primary
Change in Inflammatory and Non-inflammatory Lesion Count
Lesion counting was performed using the digital photos taken by participants and stored inside the study mobile platform by trained personnel only. Every effort was made to have the counting and clinical evaluation done by the same evaluator for a given participant. Lesions under the jaw line or behind the hairline (including eyebrows) were not included in the counts. Papules, pustules, cysts and nodules were classified as inflammatory acne lesions, and open and closed comedones were classified as non-inflammatory lesions.
Time frame: 12 weeks
Population: Efficacy analysis set: all subjects who received at least 1 application of IP
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| B244 Arm | Change in Inflammatory and Non-inflammatory Lesion Count | Change in Inflammatory Lesion Count from Baseline to Week 12 | -4.8 lesions | Standard Deviation 10.1 |
| B244 Arm | Change in Inflammatory and Non-inflammatory Lesion Count | Change in Non-Inflammatory Lesion Count from Baseline to Week 12 | -4.0 lesions | Standard Deviation 22 |
| Placebo Arm | Change in Inflammatory and Non-inflammatory Lesion Count | Change in Inflammatory Lesion Count from Baseline to Week 12 | -3.9 lesions | Standard Deviation 9.13 |
| Placebo Arm | Change in Inflammatory and Non-inflammatory Lesion Count | Change in Non-Inflammatory Lesion Count from Baseline to Week 12 | -4.9 lesions | Standard Deviation 20.9 |
Primary
Number of Participants Demonstrating Efficacy Measured by Investigator Global Assessment Success
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). IGA success was defined as a post-baseline score of 0 or 1 (yes=success, no=no success).
Time frame: 12 weeks
Population: Efficacy analysis set: all subjects who received at least 1 application of IP
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| B244 Arm | Number of Participants Demonstrating Efficacy Measured by Investigator Global Assessment Success | Yes | 25 Participants |
| B244 Arm | Number of Participants Demonstrating Efficacy Measured by Investigator Global Assessment Success | No | 127 Participants |
| Placebo Arm | Number of Participants Demonstrating Efficacy Measured by Investigator Global Assessment Success | Yes | 12 Participants |
| Placebo Arm | Number of Participants Demonstrating Efficacy Measured by Investigator Global Assessment Success | No | 137 Participants |
p-value: 0.034ANCOVA
Primary
Number of Participants With Treatment RelatedAdverse Events
Safety and tolerability endpoints will consist of all treatment related adverse events reporting during the study duration.
Time frame: 16 weeks
Population: Efficacy analysis set: all subjects who received at least 1 application of IP
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| B244 Arm | Number of Participants With Treatment RelatedAdverse Events | At Least 1 Treatment Related TEAE | 10 Participants |
| B244 Arm | Number of Participants With Treatment RelatedAdverse Events | At Least 1 Treatment Related SAE | 0 Participants |
| Placebo Arm | Number of Participants With Treatment RelatedAdverse Events | At Least 1 Treatment Related TEAE | 9 Participants |
| Placebo Arm | Number of Participants With Treatment RelatedAdverse Events | At Least 1 Treatment Related SAE | 0 Participants |
Secondary
Change in Inflammatory and Non-inflammatory Lesion Count by Week
Lesion counting was performed using the digital photos taken by participants and stored inside the study mobile platform by trained personnel only. Every effort was made to have the counting and clinical evaluation done by the same evaluator for a given participant. Lesions under the jaw line or behind the hairline (including eyebrows) were not included in the counts. Papules, pustules, cysts and nodules were classified as inflammatory acne lesions, and open and closed comedones were classified as non-inflammatory lesions.
Time frame: Baseline to weeks 2, 4, 8, 12 and 16
Population: Efficacy analysis set: all subjects who received at least 1 application of IP
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| B244 Arm | Change in Inflammatory and Non-inflammatory Lesion Count by Week | Change in Inflammatory Lesion Count from Baseline to Week 2 | -1.5 lesions | Standard Deviation 10.9 |
| B244 Arm | Change in Inflammatory and Non-inflammatory Lesion Count by Week | Change in Inflammatory Lesion Count from Baseline to Week 4 | -0.8 lesions | Standard Deviation 10.46 |
| B244 Arm | Change in Inflammatory and Non-inflammatory Lesion Count by Week | Change in Inflammatory Lesion Count from Baseline to Week 8 | -3.3 lesions | Standard Deviation 9.94 |
| B244 Arm | Change in Inflammatory and Non-inflammatory Lesion Count by Week | Change in Inflammatory Lesion Count from Baseline to Week 12 | -4.8 lesions | Standard Deviation 10.1 |
| B244 Arm | Change in Inflammatory and Non-inflammatory Lesion Count by Week | Change in Inflammatory Lesion Count from Baseline to Week 16 | -3.2 lesions | Standard Deviation 20.6 |
| B244 Arm | Change in Inflammatory and Non-inflammatory Lesion Count by Week | Change in Non-Inflammatory Lesion Count from Baseline to Week 2 | -0.9 lesions | Standard Deviation 17.1 |
| B244 Arm | Change in Inflammatory and Non-inflammatory Lesion Count by Week | Change in Non-Inflammatory Lesion Count from Baseline to Week 4 | -1.5 lesions | Standard Deviation 21.3 |
| B244 Arm | Change in Inflammatory and Non-inflammatory Lesion Count by Week | Change in Non-Inflammatory Lesion Count from Baseline to Week 8 | -4.1 lesions | Standard Deviation 20.4 |
| B244 Arm | Change in Inflammatory and Non-inflammatory Lesion Count by Week | Change in Non-Inflammatory Lesion Count from Baseline to Week 12 | -4.0 lesions | Standard Deviation 22 |
| B244 Arm | Change in Inflammatory and Non-inflammatory Lesion Count by Week | Change in Non-Inflammatory Lesion Count from Baseline to Week 16 | -6.4 lesions | Standard Deviation 23.2 |
| Placebo Arm | Change in Inflammatory and Non-inflammatory Lesion Count by Week | Change in Non-Inflammatory Lesion Count from Baseline to Week 8 | -5.8 lesions | Standard Deviation 17.4 |
| Placebo Arm | Change in Inflammatory and Non-inflammatory Lesion Count by Week | Change in Inflammatory Lesion Count from Baseline to Week 2 | -1.3 lesions | Standard Deviation 9.94 |
| Placebo Arm | Change in Inflammatory and Non-inflammatory Lesion Count by Week | Change in Non-Inflammatory Lesion Count from Baseline to Week 2 | -2.1 lesions | Standard Deviation 18.4 |
| Placebo Arm | Change in Inflammatory and Non-inflammatory Lesion Count by Week | Change in Inflammatory Lesion Count from Baseline to Week 4 | -0.8 lesions | Standard Deviation 9.49 |
| Placebo Arm | Change in Inflammatory and Non-inflammatory Lesion Count by Week | Change in Non-Inflammatory Lesion Count from Baseline to Week 16 | -6.1 lesions | Standard Deviation 21.7 |
| Placebo Arm | Change in Inflammatory and Non-inflammatory Lesion Count by Week | Change in Inflammatory Lesion Count from Baseline to Week 8 | -3.1 lesions | Standard Deviation 8.75 |
| Placebo Arm | Change in Inflammatory and Non-inflammatory Lesion Count by Week | Change in Non-Inflammatory Lesion Count from Baseline to Week 4 | -4.6 lesions | Standard Deviation 19.1 |
| Placebo Arm | Change in Inflammatory and Non-inflammatory Lesion Count by Week | Change in Inflammatory Lesion Count from Baseline to Week 12 | -3.9 lesions | Standard Deviation 9.13 |
| Placebo Arm | Change in Inflammatory and Non-inflammatory Lesion Count by Week | Change in Non-Inflammatory Lesion Count from Baseline to Week 12 | -4.9 lesions | Standard Deviation 20.9 |
| Placebo Arm | Change in Inflammatory and Non-inflammatory Lesion Count by Week | Change in Inflammatory Lesion Count from Baseline to Week 16 | -4.0 lesions | Standard Deviation 11.4 |
Secondary
Change in Patient Reported Quality of Life Score Using the Skindex-16 Questionnaire
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 weeks 2, 4, 8, 12 and 16
Population: Efficacy analysis set: all subjects who received at least 1 application of IP
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| B244 Arm | Change in Patient Reported Quality of Life Score Using the Skindex-16 Questionnaire | Change from Baseline to Week 4 | -0.7 score on a scale | Standard Deviation 1.1 |
| B244 Arm | Change in Patient Reported Quality of Life Score Using the Skindex-16 Questionnaire | Change from Baseline to Week 12 | -0.7 score on a scale | Standard Deviation 1.16 |
| B244 Arm | Change in Patient Reported Quality of Life Score Using the Skindex-16 Questionnaire | Change from Baseline to Week 8 | -0.6 score on a scale | Standard Deviation 1.23 |
| B244 Arm | Change in Patient Reported Quality of Life Score Using the Skindex-16 Questionnaire | Change from Baseline to Week 16 | -0.8 score on a scale | Standard Deviation 1.16 |
| B244 Arm | Change in Patient Reported Quality of Life Score Using the Skindex-16 Questionnaire | Change from Baseline to Week 2 | -0.6 score on a scale | Standard Deviation 1.05 |
| Placebo Arm | Change in Patient Reported Quality of Life Score Using the Skindex-16 Questionnaire | Change from Baseline to Week 16 | -0.7 score on a scale | Standard Deviation 1.17 |
| Placebo Arm | Change in Patient Reported Quality of Life Score Using the Skindex-16 Questionnaire | Change from Baseline to Week 2 | -1.6 score on a scale | Standard Deviation 0.97 |
| Placebo Arm | Change in Patient Reported Quality of Life Score Using the Skindex-16 Questionnaire | Change from Baseline to Week 4 | -0.7 score on a scale | Standard Deviation 1.12 |
| Placebo Arm | Change in Patient Reported Quality of Life Score Using the Skindex-16 Questionnaire | Change from Baseline to Week 8 | -0.7 score on a scale | Standard Deviation 1.16 |
| Placebo Arm | Change in Patient Reported Quality of Life Score Using the Skindex-16 Questionnaire | Change from Baseline to Week 12 | -0.6 score on a scale | Standard Deviation 1.17 |
Secondary
Number of Participants Demonstrating Efficacy Measured Investigator Global Assessment Score by Week
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). IGA success was defined as a post-baseline score of 0 or 1 (yes=success, no=no success).
Time frame: Baseline to weeks 2, 4, 8, 12 and 16
Population: Subjects from the efficacy analysis set (all subjects who received at least 1 application of IP) that remained in the study up to each respective time point for the outcome measure.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| B244 Arm | Number of Participants Demonstrating Efficacy Measured Investigator Global Assessment Score by Week | Week 2 | Yes | 12 Participants |
| B244 Arm | Number of Participants Demonstrating Efficacy Measured Investigator Global Assessment Score by Week | Week 2 | No | 162 Participants |
| B244 Arm | Number of Participants Demonstrating Efficacy Measured Investigator Global Assessment Score by Week | Week 4 | Yes | 9 Participants |
| B244 Arm | Number of Participants Demonstrating Efficacy Measured Investigator Global Assessment Score by Week | Week 4 | No | 159 Participants |
| B244 Arm | Number of Participants Demonstrating Efficacy Measured Investigator Global Assessment Score by Week | Week 8 | Yes | 16 Participants |
| B244 Arm | Number of Participants Demonstrating Efficacy Measured Investigator Global Assessment Score by Week | Week 8 | No | 144 Participants |
| B244 Arm | Number of Participants Demonstrating Efficacy Measured Investigator Global Assessment Score by Week | Week 12 | Yes | 25 Participants |
| B244 Arm | Number of Participants Demonstrating Efficacy Measured Investigator Global Assessment Score by Week | Week 12 | No | 127 Participants |
| B244 Arm | Number of Participants Demonstrating Efficacy Measured Investigator Global Assessment Score by Week | Week 16 | Yes | 12 Participants |
| B244 Arm | Number of Participants Demonstrating Efficacy Measured Investigator Global Assessment Score by Week | Week 16 | No | 140 Participants |
| Placebo Arm | Number of Participants Demonstrating Efficacy Measured Investigator Global Assessment Score by Week | Week 12 | No | 137 Participants |
| Placebo Arm | Number of Participants Demonstrating Efficacy Measured Investigator Global Assessment Score by Week | Week 2 | Yes | 13 Participants |
| Placebo Arm | Number of Participants Demonstrating Efficacy Measured Investigator Global Assessment Score by Week | Week 8 | No | 150 Participants |
| Placebo Arm | Number of Participants Demonstrating Efficacy Measured Investigator Global Assessment Score by Week | Week 2 | No | 157 Participants |
| Placebo Arm | Number of Participants Demonstrating Efficacy Measured Investigator Global Assessment Score by Week | Week 16 | No | 131 Participants |
| Placebo Arm | Number of Participants Demonstrating Efficacy Measured Investigator Global Assessment Score by Week | Week 4 | Yes | 13 Participants |
| Placebo Arm | Number of Participants Demonstrating Efficacy Measured Investigator Global Assessment Score by Week | Week 12 | Yes | 12 Participants |
| Placebo Arm | Number of Participants Demonstrating Efficacy Measured Investigator Global Assessment Score by Week | Week 4 | No | 153 Participants |
| Placebo Arm | Number of Participants Demonstrating Efficacy Measured Investigator Global Assessment Score by Week | Week 16 | Yes | 17 Participants |
| Placebo Arm | Number of Participants Demonstrating Efficacy Measured Investigator Global Assessment Score by Week | Week 8 | Yes | 10 Participants |
Other Pre-specified
To Evaluate Facial Skin Microbiota
Evaluate if B244 administration on skin twice daily will affect the microbial content on collected skin swab samples.
Time frame: baseline, week 4, week 8, week 12, and week 16
Population: Data was not collected for this exploratory endpoint.