Trials Sponsors Conditions Drugs Pricing

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (1)

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.
Baseline to Week 12

Secondary Outcomes (6)

Mean change in log inflammatory lesion count
Baseline to Week 12
Mean change in absolute lesion count
Baseline to Week 2, 4, 8, 12, 16
Mean change in log inflammatory lesion count
Baseline to Week 2, 4, 8, 16
Percent change in inflammatory lesion count
Baseline to Week 2, 4, 8, 12, 16
Proportion of participants with IGA 0 (clear) or 1 (almost clear) and ≥2-point improvement
Baseline to Week 2, 4, 8, 16
+1 more secondary outcomes

Other Outcomes (12)

Mean change in absolute and log total lesion count
Baseline to Week 2, 4, 8, 12, 16
Percent change in total lesion count
Baseline to Week 2, 4, 8, 12, 16
Mean change in absolute and log non-inflammatory lesion count
Baseline to Week 2, 4, 8, 12, 16
+9 more other outcomes

Study Arms (2)

B244 Suspension O.D. 5.0

EXPERIMENTAL

One arm of 88 Subjects will be receiving a dose of B244 O.D. 5.0 suspension

Biological: B244

Placebo

PLACEBO COMPARATOR

Second arm of 88 subjects will receive a vehicle dosing

Biological: Vehicle

Interventions

B244Biological

B244 suspension

B244 Suspension O.D. 5.0

VehicleBiological

Vehicle suspension

Placebo

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age12 Years+

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

AOBiome LLC
Industrylead
bioRASI, LLC
Industrycollaborator

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Study Officials

Hyun Kim, PhD
AOBiome LLC
STUDY DIRECTOR

Central Study Contacts

Hyun Kim, PhD

CONTACT

781-439-7159 hkim@aobiome.com

Connie Li, MEng

CONTACT

connie@aobiome.com

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details: Double-blind, vehicle-controlled, randomized in a 1:1 ratio
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 5, 2026

First Posted

October 8, 2026

Study Start

October 2026

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Primary Completion

You may not qualify if:

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
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
+16 more criteria

Study to Determine Efficacy, Safety, and Tolerability of B244 as a Topical Spray in Subjects With Moderate to Severe Acne Vulgaris

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Other Outcomes (12)

Study Arms (2)

B244 Suspension O.D. 5.0

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Other Outcomes (12)

Study Arms (2)

B244 Suspension O.D. 5.0

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record