Acne VulgarisPhase 2NCT07866105
Study to Determine Efficacy, Safety, and Tolerability of B244 as a Topical Spray in Subjects With Moderate to Severe Acne Vulgaris
A Phase 2 study testing B244 in people with Acne Vulgaris, run by AOBiome LLC.
Trial summary
This is a phase 2b, randomized, double-blind, vehicle-controlled clinical trial evaluating the efficacy, safety, and tolerability of B244 compared to vehicle in the treatment of moderate to severe acne vulgaris in adolescents and adults. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- B244
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 176 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Males and females age 12 years and older
- Participants (and/or parents or guardians) willing and able to provide informed consent/assent and to comply with the study protocol
- Clinical diagnosis of moderate to severe facial acne vulgaris defined as the following at Screening and Baseline:
- IGA 3-4, and;
- ≥20 to ≤100 inflammatory lesions (papules, pustules, nodules), and;
- ≥30 to ≤150 non-inflammatory lesions (open comedones or blackheads, closed comedones or whiteheads), and
Show all 12Show fewer
- ≤2 nodules, and
- 0 cysts
- Willing to refrain from using any acne treatments other than the investigational product for the duration of the study
- Willing and able to complete once-daily eDiary entries within a consistent timeframe for the duration of the study
- Judged to be in good health in the Investigator's opinion
- Ability and willingness to abstain from taking medications not allowed by the protocol for the duration of the study
Who cannot join
- Use of topical acne treatments, including benzoyl peroxide within 2 weeks prior to randomization to end of follow-up, retinoids (e.g., tretinoin, tazarotene, adapalene, trifarotene) within 4 weeks prior to randomization to end of follow up, antibiotics (e.g., clindamycin, erythromycin, dapsone), and combinations thereof, within 2 weeks prior to randomization to end of follow-up
- Use of oral/systemic acne treatments, including antibiotics (e.g., minocycline, doxycycline, tetracycline, erythromycin, trimethoprim sulfamethoxazole, dapsone) within 4 weeks prior to randomization to end of follow-up, retinoid (e.g., isotretinoin or its derivatives) within 6 months prior to randomization to end of follow-up, vitamin A (retinol) supplements greater than 10,000 units/day within 4 weeks prior to randomization to end of follow-up, and zinc within 4 weeks prior to randomization to end of follow-up
- Use of oral/systemic androgen receptor blockers (such as spironolactone, flutamide, cyproterone acetate, or bicalutamide) within 3 months prior to randomization to end of follow-up
- Use of topical androgen receptor blockers (such as clascoterone) within 4 weeks prior to randomization to end of follow-up
- Use of over-the-counter topical medications for the treatment of acne vulgaris including benzoyl peroxide, topical anti-inflammatory medications, corticosteroids, or topical probiotics within 2 weeks prior to randomization to end of follow-up
- Use of systemic corticosteroids within 4 weeks prior to randomization to end of follow-up
Show all 31Show fewer
- Any clinically significant changes in type, dose, or frequency of bland emollients throughout the study from screening to follow-up
- Use of photodynamic therapy, UV phototherapy, laser therapy of any type, chemical peels, microdermabrasion, comedone extraction, intralesional corticosteroid injections, or other procedural acne treatment on the face within 3 months prior to randomization to end of follow-up
- Treatment with systemic immunosuppressive/ immunomodulatory therapies within 4 weeks prior to randomization (including but not limited to cyclosporine, mycophenolate-mofetil, methotrexate, azathioprine, interferon gamma)
- Use of medications known to cause or exacerbate acneiform eruptions including lithium, anabolic steroids, adrenocorticotropic hormone, halogenated compounds, phenytoin, JAK/TYK-2 inhibitors, tapinarof or other aryl hydrocarbon receptor (AhR) agonists used for dermatological indications, EGFR inhibitors, mTOR inhibitors, or high-dose standalone vitamin B12 supplementation within 4 weeks prior to randomization to end of follow-up; standard multivitamin formulations are permitted
- Use of any non-steroidal and non-immunomodulatory topical treatment for acne (other than bland emollient that will be continued during the study period) within 2 weeks prior to randomization to end of follow-up
- Use of an indoor tanning facility, or outdoor intense sun exposure, sunbathing, or suntanning within 4 weeks prior to randomization to end of follow-up
- Treatment with any investigational therapy within 4 weeks prior to randomization to end of follow-up
- Allergen immunotherapy within 6 months prior to randomization to end of follow-up
- Use of acne-specific skin care products within 2 weeks prior to randomization to end of follow-up
- Use of traditional Chinese medicine for acne within 2 weeks prior to randomization to end of follow-up
- Use of keratolytic or peeling agents (e.g., a-hydroxy acid, glycolic acid, salicylic acid, azelaic acid) within 2 weeks prior to randomization to end of follow-up
- Concurrent skin diseases affecting efficacy evaluation (e.g., dermatitis, psoriasis, rosacea)
- Nodulocystic acne, secondary acne (e.g., occupational or steroid- induced acne, chloracne, acne mechanica), acne conglobata, acne fulminans, or any other acne variant
- Facial hair hindering acne assessment
- 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, contraindicates their participation
- 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, 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)
- History of malignancy within 5 years prior to randomization, with the exception of completely treated and non-metastatic basal cell carcinoma or squamous cell carcinoma of the skin
- History of a major psychiatric condition (including major depressive disorder, bipolar disorder, or schizophrenia), suicidal ideation, or suicide attempt
- Known active hepatitis infection
- Known history of human immunodeficiency virus (HIV) infection
- Presence of any clinically significant systemic disease, laboratory abnormality, medical condition or disability that, in the Investigator's opinion, could interfere with the assessment of safety or efficacy in this trial or compromise the safety of the participant
- Currently pregnant or breastfeeding, or male participant with a pregnant or breastfeeding partner
- Females of childbearing potential who are unable or unwilling to practice highly effective contraception (pregnancy prevention); fertile males who are unable or unwilling to use condoms with female partners of childbearing potential
- The participant has been previously randomized in this study
- Inability to give informed consent
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Connie Li, MEng contact
About this study
Official title: A Phase 2b, Randomized, Double-Blind, Vehicle-Controlled Multi-Center Study of the Efficacy, Safety, and Tolerability of B244 Delivered as a Topical Spray in the Treatment of Moderate to Severe Acne Vulgaris
This is a phase 2b, randomized, double-blind, vehicle-controlled clinical trial evaluating the efficacy, safety, and tolerability of B244 compared to vehicle in the treatment of moderate to severe acne vulgaris in adolescents and adults. Participants who meet the study entry criteria will be randomized in a 1:1 ratio to receive twice daily topical doses of B244 O.D. 5.0 or vehicle (control) for 12 weeks.
Read the detailed description
This is a 16-week, phase 2b, multicenter, randomized, double-blind, vehicle-controlled study to assess the efficacy, safety, and tolerability of B244 for the treatment of moderate to severe acne vulgaris (IGA 3-4) in adolescents (ages 12 to <18 years) and adults (ages ≥18 years).
- Approximately 176 participants (88 per treatment arm) will be enrolled and randomized to provide 150 completers (75 per arm). Randomization will be allocated 1:1, stratified by baseline IGA score (3 vs. 4). Target enrollment: approximately 30% adolescents (12 to <18 years); approximately 30% severe acne (IGA 4); prior isotretinoin use capped at 20%
- Study population: male and female adolescents and adults (12 years of age and older) with moderate to severe acne vulgaris (IGA 3-4)
- At Screening and Baseline, all participants must have a clinical diagnosis of moderate to severe facial acne vulgaris defined as: IGA 3-4; ≥20 to ≤100 inflammatory lesions (papules, pustules, nodules); ≥30 to ≤150 non-inflammatory lesions (open comedones/blackheads and closed comedones/whiteheads); ≤2 nodules; and 0 cysts
- Prior acne medication use and outcomes will be documented in the eCRF
- Including the screening and follow-up periods, the total duration of the study will be approximately 18-20 weeks. Participants will report for a Screening visit and, if all inclusion/exclusion criteria are met, will undergo a 2- to 4-week washout phase (or longer if needed) before reporting for a Baseline visit
- At the Baseline visit, participants who meet the study entry criteria will be randomized in a 1:1 ratio to receive twice daily topical doses of B244 at O.D. 5.0 or vehicle (control) for 12 weeks
- Participants will attend in-clinic visits at Weeks 2, 4, 8, and 12. After completion of the 12-week treatment period, participants will enter a 4-week follow-up period (without further study-provided treatment) with a Week 16 visit
- Participants who discontinue the study early will be evaluated by the Investigator at the Early Termination Visit within 7 days after their last dose of study drug
- All patient-reported outcomes and clinical outcome assessments (ePRO/eCOA) will be obtained electronically using either a smartphone application or a tablet. Participants will be provided with an eDiary at Screening to initiate daily diary entries from Baseline to follow-up at home, including daily dose confirmation (whether IP was administered, number of pumps per application, and location of application during the treatment period) and local skin tolerability (Day 1 to Day 7 of treatment). Skindex-16, DLQI/CDLQI, PGIS, PGIC, and EQ-5D-5L will be reported by participants at designated site visits using a site-provided tablet. IGA, inflammatory lesion count (papules, pustules, nodules), non-inflammatory lesion count (open comedones, closed comedones), and total lesion count will also be assessed at designated site visits by the clinician. In order to avoid bias in participants' responses, all patient-reported assessments will be completed (with anchor-based PGIS and PGIC last) before clinician-reported assessments
- Participants must be willing and able to complete eDiary within a consistent timeframe on a daily basis and to comply with restrictions on allowable/prohibited therapies for the duration of the study
- All participants will attend a Screening visit 14 to 28 days prior to Baseline (Days -14 to - 28). Participants will be required to return to the clinic at Baseline (Day 1), Day 15 (Week 2), Day 29 (Week 4), Day 57 (Week 8), and Day 85 (Week 12). All participants will be asked to attend a Day 113 (Week 16) follow-up visit 4 weeks (28 days (±3) days) after the last dose of study medication
- Minimum of four (4) pumps of spray self-applied to the face BID for 12 weeks. Up to eight (8) pumps can be applied based on larger affected area involvement including face, neck, upper chest, or upper back. All areas identified at Baseline should continue to be treated through the end of the vehicle-controlled treatment period
- The primary efficacy endpoint will be assessed at Week 12 of treatment. Efficacy assessment will be limited to the face
- The study will be conducted at approximately 15 study sites
- Safety evaluations will consist of review of the participant's medical history at screening and ongoing assessment of adverse events throughout the study duration, supplemented by laboratory assessments, vital signs, and physical examinations at specified visits
- Conditions
- Acne Vulgaris
- Being tested
- B244, Vehicle
- Medical subject headings
- Acne Vulgaris
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 Suspension O.D. 5.0 | Experimental | One arm of 88 Subjects will be receiving a dose of B244 O.D. 5.0 suspension Receives: Biological: B244 |
| Placebo | Placebo comparator | Second arm of 88 subjects will receive a vehicle dosing Receives: Biological: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with IGA success, defined as IGA 0 (clear) or 1 (almost clear) and ≥2-point improvement
The Investigator Global Assessment (IGA) is a validated 5-point static scale (0 = Clear to 4 = Severe) used to rate the overall severity of facial acne vulgaris at each assessment timepoint.
Measured: Baseline to Week 12
Secondary outcomes (6)
Mean change in log inflammatory lesion count
Inflammatory lesions are defined as papules, pustules, and nodules (cysts are excluded from eligibility). The inflammatory lesion count provides a continuous, objective, quantitative measure of disease activity that is sensitive to treatment effects and endorsed by the FDA as a co-primary or key secondary endpoint in acne drug development. The mean change in log-transformed lesion count corresponds to a geometric mean ratio, which can be interpreted as a proportional reduction in inflammatory burden.
Measured: Baseline to Week 12
Mean change in absolute lesion count
Absolute lesion count changes complement the log-transformed analysis by providing directly interpretable counts of lesion reductions.
Measured: Baseline to Week 2, 4, 8, 12, 16
Mean change in log inflammatory lesion count
Inflammatory lesions are defined as papules, pustules, and nodules (cysts are excluded from eligibility). The inflammatory lesion count provides a continuous, objective, quantitative measure of disease activity that is sensitive to treatment effects and endorsed by the FDA as a co-primary or key secondary endpoint in acne drug development. The mean change in log-transformed lesion count corresponds to a geometric mean ratio, which can be interpreted as a proportional reduction in inflammatory burden.
Measured: Baseline to Week 2, 4, 8, 16
Percent change in inflammatory lesion count
Inflammatory lesions are defined as papules, pustules, and nodules (cysts are excluded from eligibility). The inflammatory lesion count provides a continuous, objective, quantitative measure of disease activity that is sensitive to treatment effects and endorsed by the FDA as a co-primary or key secondary endpoint in acne drug development. The mean change in log-transformed lesion count corresponds to a geometric mean ratio, which can be interpreted as a proportional reduction in inflammatory burden.
Measured: Baseline to Week 2, 4, 8, 12, 16
Proportion of participants with IGA 0 (clear) or 1 (almost clear) and ≥2-point improvement
The Investigator Global Assessment (IGA) is a validated 5-point static scale (0 = Clear to 4 = Severe) used to rate the overall severity of facial acne vulgaris at each assessment timepoint.
Measured: Baseline to Week 2, 4, 8, 16
Proportion of participants with IGA 0 (clear) or 1 (almost clear)
The Investigator Global Assessment (IGA) is a validated 5-point static scale (0 = Clear to 4 = Severe) used to rate the overall severity of facial acne vulgaris at each assessment timepoint.
Measured: Week 2, 4, 8, 12, 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionSep 2027 (estimated)
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AOBiome LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- bioRASI, LLC
- Responsible party
- Sponsor
- Investigators
- Hyun Kim, PhD, Study director, AOBiome LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07866105
- Sponsor's protocol ID
- AVB244-006
- Status last verified
- Oct 2026
- First submitted
- 5 Oct 2026
- Last updated
- 8 Oct 2026
- Results posted
- 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 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b, Randomized, Double-Blind, Vehicle-Controlled Multi-Center Study of the Efficacy, Safety, and Tolerability of B244 Delivered as a Topical Spray in the Treatment of Moderate to Severe Acne Vulgaris
- ClinicalTrials.gov ID
- NCT07866105
- Acronym / sponsor ID
- AVB244-006
- Conditions
- Acne Vulgaris
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- AOBiome LLCIndustry (pharma, biotech, devices)
- Collaborators
- bioRASI, LLC
- Study start
- Oct 2026 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 8 Oct 2026 (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 phase 2b, randomized, double-blind, vehicle-controlled clinical trial evaluating the efficacy, safety, and tolerability of B244 compared to vehicle in the treatment of moderate to severe acne vulgaris in adolescents and adults. Participants who meet the study entry criteria will be randomized in a 1:1 ratio to receive twice daily topical doses of B244 O.D. 5.0 or vehicle (control) for 12 weeks.
Detailed description
This is a 16-week, phase 2b, multicenter, randomized, double-blind, vehicle-controlled study to assess the efficacy, safety, and tolerability of B244 for the treatment of moderate to severe acne vulgaris (IGA 3-4) in adolescents (ages 12 to <18 years) and adults (ages ≥18 years).
- Approximately 176 participants (88 per treatment arm) will be enrolled and randomized to provide 150 completers (75 per arm). Randomization will be allocated 1:1, stratified by baseline IGA score (3 vs. 4). Target enrollment: approximately 30% adolescents (12 to <18 years); approximately 30% severe acne (IGA 4); prior isotretinoin use capped at 20%
- Study population: male and female adolescents and adults (12 years of age and older) with moderate to severe acne vulgaris (IGA 3-4)
- At Screening and Baseline, all participants must have a clinical diagnosis of moderate to severe facial acne vulgaris defined as: IGA 3-4; ≥20 to ≤100 inflammatory lesions (papules, pustules, nodules); ≥30 to ≤150 non-inflammatory lesions (open comedones/blackheads and closed comedones/whiteheads); ≤2 nodules; and 0 cysts
- Prior acne medication use and outcomes will be documented in the eCRF
- Including the screening and follow-up periods, the total duration of the study will be approximately 18-20 weeks. Participants will report for a Screening visit and, if all inclusion/exclusion criteria are met, will undergo a 2- to 4-week washout phase (or longer if needed) before reporting for a Baseline visit
- At the Baseline visit, participants who meet the study entry criteria will be randomized in a 1:1 ratio to receive twice daily topical doses of B244 at O.D. 5.0 or vehicle (control) for 12 weeks
- Participants will attend in-clinic visits at Weeks 2, 4, 8, and 12. After completion of the 12-week treatment period, participants will enter a 4-week follow-up period (without further study-provided treatment) with a Week 16 visit
- Participants who discontinue the study early will be evaluated by the Investigator at the Early Termination Visit within 7 days after their last dose of study drug
- All patient-reported outcomes and clinical outcome assessments (ePRO/eCOA) will be obtained electronically using either a smartphone application or a tablet. Participants will be provided with an eDiary at Screening to initiate daily diary entries from Baseline to follow-up at home, including daily dose confirmation (whether IP was administered, number of pumps per application, and location of application during the treatment period) and local skin tolerability (Day 1 to Day 7 of treatment). Skindex-16, DLQI/CDLQI, PGIS, PGIC, and EQ-5D-5L will be reported by participants at designated site visits using a site-provided tablet. IGA, inflammatory lesion count (papules, pustules, nodules), non-inflammatory lesion count (open comedones, closed comedones), and total lesion count will also be assessed at designated site visits by the clinician. In order to avoid bias in participants' responses, all patient-reported assessments will be completed (with anchor-based PGIS and PGIC last) before clinician-reported assessments
- Participants must be willing and able to complete eDiary within a consistent timeframe on a daily basis and to comply with restrictions on allowable/prohibited therapies for the duration of the study
- All participants will attend a Screening visit 14 to 28 days prior to Baseline (Days -14 to - 28). Participants will be required to return to the clinic at Baseline (Day 1), Day 15 (Week 2), Day 29 (Week 4), Day 57 (Week 8), and Day 85 (Week 12). All participants will be asked to attend a Day 113 (Week 16) follow-up visit 4 weeks (28 days (±3) days) after the last dose of study medication
- Minimum of four (4) pumps of spray self-applied to the face BID for 12 weeks. Up to eight (8) pumps can be applied based on larger affected area involvement including face, neck, upper chest, or upper back. All areas identified at Baseline should continue to be treated through the end of the vehicle-controlled treatment period
- The primary efficacy endpoint will be assessed at Week 12 of treatment. Efficacy assessment will be limited to the face
- The study will be conducted at approximately 15 study sites
- Safety evaluations will consist of review of the participant's medical history at screening and ongoing assessment of adverse events throughout the study duration, supplemented by laboratory assessments, vital signs, and physical examinations at specified visits
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| B244 Suspension O.D. 5.0 | Experimental | Biological: B244One arm of 88 Subjects will be receiving a dose of B244 O.D. 5.0 suspension |
| Placebo | Placebo comparator | Biological: VehicleSecond arm of 88 subjects will receive a vehicle dosing |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Males and females age 12 years and older
- Participants (and/or parents or guardians) willing and able to provide informed consent/assent and to comply with the study protocol
- Clinical diagnosis of moderate to severe facial acne vulgaris defined as the following at Screening and Baseline:
- Willing to refrain from using any acne treatments other than the investigational product for the duration of the study
- Willing and able to complete once-daily eDiary entries within a consistent timeframe for the duration of the study
Key exclusion criteria (31 listed)
- Use of topical acne treatments, including benzoyl peroxide within 2 weeks prior to randomization to end of follow-up, retinoids (e.g., tretinoin, tazarotene, adapalene, trifarotene) within 4 weeks prior to randomization to end of follow up, antibiotics (e.g., clindamycin, erythromycin, dapsone), and combinations thereof, within 2 weeks prior to randomization to end of follow-up
- Use of oral/systemic acne treatments, including antibiotics (e.g., minocycline, doxycycline, tetracycline, erythromycin, trimethoprim sulfamethoxazole, dapsone) within 4 weeks prior to randomization to end of follow-up, retinoid (e.g., isotretinoin or its derivatives) within 6 months prior to randomization to end of follow-up, vitamin A (retinol) supplements greater than 10,000 units/day within 4 weeks prior to randomization to end of follow-up, and zinc within 4 weeks prior to randomization to end of follow-up
- Use of oral/systemic androgen receptor blockers (such as spironolactone, flutamide, cyproterone acetate, or bicalutamide) within 3 months prior to randomization to end of follow-up
- Use of topical androgen receptor blockers (such as clascoterone) within 4 weeks prior to randomization to end of follow-up
- Use of over-the-counter topical medications for the treatment of acne vulgaris including benzoyl peroxide, topical anti-inflammatory medications, corticosteroids, or topical probiotics within 2 weeks prior to randomization to end of follow-up
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 Suspension O.D. 5.0 |
| VehicleVehicle suspension | Biological | Placebo |
Primary outcome
Proportion of participants with IGA success, defined as IGA 0 (clear) or 1 (almost clear) and ≥2-point improvement
Time frame: Baseline to Week 12
The Investigator Global Assessment (IGA) is a validated 5-point static scale (0 = Clear to 4 = Severe) used to rate the overall severity of facial acne vulgaris at each assessment timepoint.
6 secondary outcomes
Mean change in log inflammatory lesion count
Time frame: Baseline to Week 12
Mean change in absolute lesion count
Time frame: Baseline to Week 2, 4, 8, 12, 16
Mean change in log inflammatory lesion count
Time frame: Baseline to Week 2, 4, 8, 16
Percent change in inflammatory lesion count
Time frame: Baseline to Week 2, 4, 8, 12, 16
Proportion of participants with IGA 0 (clear) or 1 (almost clear) and ≥2-point improvement
Time frame: Baseline to Week 2, 4, 8, 16
Proportion of participants with IGA 0 (clear) or 1 (almost clear)
Time frame: Week 2, 4, 8, 12, 16
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- 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.
Connie Li, MEng contact
Hyun Kim, PhD study director
AOBiome LLC
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing B244 in people with Acne Vulgaris, run by AOBiome LLC.
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 12 inclusion and 31 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: opening soon, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hyun Kim, PhD (781-439-7159, hkim@aobiome.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with IGA success, defined as IGA 0 (clear) or 1 (almost clear) and ≥2-point improvement (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 8 Oct 2026.