[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659485":3},{"organization":4,"outcomesModule":7,"designInfo":65,"detailedDescription":78,"studyPopulation":68,"armGroups":79,"interventions":92,"overallOfficials":102,"centralContacts":106,"locations":68,"responsibleParty":114,"collaborators":116,"id":119,"slug":120,"hasResults":121,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":68,"eligibilityCriteria":125,"healthyVolunteers":121,"sex":126,"minAge":127,"maxAge":68,"enrollmentInfo":128,"targetDuration":68,"studyType":131,"phases":132,"briefSummary":134,"conditions":135,"keywords":68,"overallStatus":137,"whyStopped":68,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":68},{"fullName":5,"class":6},"AOBiome LLC","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":30},[9],{"measure":10,"description":11,"timeFrame":12},"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",[14,17,21,23,25,27],{"measure":15,"description":16,"timeFrame":12},"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.",{"measure":18,"description":19,"timeFrame":20},"Mean change in absolute lesion count","Absolute lesion count changes complement the log-transformed analysis by providing directly interpretable counts of lesion reductions.","Baseline to Week 2, 4, 8, 12, 16",{"measure":15,"description":16,"timeFrame":22},"Baseline to Week 2, 4, 8, 16",{"measure":24,"description":16,"timeFrame":20},"Percent change in inflammatory lesion count",{"measure":26,"description":11,"timeFrame":22},"Proportion of participants with IGA 0 (clear) or 1 (almost clear) and ≥2-point improvement",{"measure":28,"description":11,"timeFrame":29},"Proportion of participants with IGA 0 (clear) or 1 (almost clear)","Week 2, 4, 8, 12, 16",[31,34,37,40,43,46,49,52,55,58,60,63],{"measure":32,"description":33,"timeFrame":20},"Mean change in absolute and log total lesion count","Lesion count data are log-transformed prior to analysis to normalize the characteristically right- skewed distribution of count data. 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. Absolute lesion count changes complement the log-transformed analysis by providing directly interpretable counts of lesion reductions.",{"measure":35,"description":36,"timeFrame":20},"Percent change in total lesion count","The total lesion count is the sum of total inflammatory and total non-inflammatory lesion counts.",{"measure":38,"description":39,"timeFrame":20},"Mean change in absolute and log non-inflammatory lesion count","Absolute lesion count changes complement the log-transformed analysis by providing directly interpretable counts of lesion reductions. Non-inflammatory lesion counts capture comedone burden, which is an important component of acne pathophysiology that may respond differently to treatment than inflammatory lesions.",{"measure":41,"description":42,"timeFrame":20},"Percent change in non-inflammatory lesion count","Non-inflammatory lesion counts capture comedone burden, which is an important component of acne pathophysiology that may respond differently to treatment than inflammatory lesions. Non-inflammatory lesions: open comedones (blackheads) and closed comedones (whiteheads) (counted separately; summed as total non-inflammatory lesion count).",{"measure":44,"description":45,"timeFrame":20},"Mean change in number of nodules","Nodule count changes provide specific information on the most severe acne lesion type.",{"measure":47,"description":48,"timeFrame":20},"Mean change in Skindex-16","The Skindex-16 is a validated, 16-item, dermatology-specific patient-reported outcome instrument assessing the impact of skin disease on health-related quality of life over the past week. Items are grouped into three domains: Symptoms (4 items), Emotions (7 items), and Functioning (5 items). Each item is scored on a 7-point scale (0 = Never Bothered to 6 = Always Bothered), which is then multiplied by 16.667 to transform responses to a 0 100 scale; domain scores and total score are expressed on a 0-100 scale (higher scores = greater burden).",{"measure":50,"description":51,"timeFrame":20},"Mean change in DLQI\u002FCDLQI","The Dermatology Life Quality Index (DLQI)\u002F Children's Dermatology Life Quality Index (CDLQI) are validated 10-item dermatology-specific quality-of-life questionnaires scored 0-30; higher scores indicate greater disease impact. DLQI consists of 10 questions concerning patients' perception of the impact of skin diseases on different aspects of their health-related quality of life over the last week. CDLQI is designed to measure the impact of any skin disease on the lives of children.",{"measure":53,"description":54,"timeFrame":20},"Mean change in EQ-5D-5L","The EQ-5D-5L (Euro Quality of life 5 Dimension 5 Level) is a validated, self administered, generic health status measure assessing five dimensions on a 5-level scale (mobility, self-care, usual activities, pain\u002Fdiscomfort, anxiety\u002Fdepression) plus a 0-100 VAS for overall current health state today from 0 (worst imaginable) to 100 (best imaginable).",{"measure":56,"description":57,"timeFrame":20},"Mean change in Patient Global Impression of Severity (PGIS) score","The Patient Global Impression of Severity (PGIS) is a single-item PRO on which participants rate the severity of their acne right now on a 7-point scale ranging from 1 = Not Present to 7 = Extremely Severe, providing participant perspective complementary to the investigator-assessed IGA.",{"measure":59,"description":57,"timeFrame":29},"Proportion of participants with a PGIS score of 1 (not present) or 2 (very mild) at Week 2, 4, 8, 12, 16 who did not report a PGIS score of 1 or 2 at Baseline",{"measure":61,"description":62,"timeFrame":29},"Mean Patient Global Impression of Change (PGIC) score","The Patient Global Impression of Change (PGIC) is a single-item PRO on which participants rate the overall change in their acne since the start of treatment on a 7-point scale (1=Very Much Improved to 7=Very Much Worse). PGIC is a participants' self-reporting measure that reflects their belief about the efficacy of treatment depicting a participant's rating of overall improvement.",{"measure":64,"description":62,"timeFrame":29},"Proportion of participants with a PGIC score of 1 (very much improved) or 2 (much improved)",{"allocation":66,"interventionModel":67,"interventionModelDescription":68,"primaryPurpose":69,"observationalModel":68,"timePerspective":68,"maskingInfo":70},"RANDOMIZED","PARALLEL",null,"TREATMENT",{"masking":71,"maskingDescription":72,"whoMasked":73},"QUADRUPLE","Double-blind, vehicle-controlled, randomized in a 1:1 ratio",[74,75,76,77],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","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 \\\u003C18 years) and adults (ages ≥18 years).\n\n* 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 \\\u003C18 years); approximately 30% severe acne (IGA 4); prior isotretinoin use capped at 20%\n* Study population: male and female adolescents and adults (12 years of age and older) with moderate to severe acne vulgaris (IGA 3-4)\n* 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\u002Fblackheads and closed comedones\u002Fwhiteheads); ≤2 nodules; and 0 cysts\n* Prior acne medication use and outcomes will be documented in the eCRF\n* 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\u002Fexclusion criteria are met, will undergo a 2- to 4-week washout phase (or longer if needed) before reporting for a Baseline visit\n* 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\n* 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\n* 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\n* All patient-reported outcomes and clinical outcome assessments (ePRO\u002FeCOA) 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\u002FCDLQI, 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\n* Participants must be willing and able to complete eDiary within a consistent timeframe on a daily basis and to comply with restrictions on allowable\u002Fprohibited therapies for the duration of the study\n* 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\n* 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\n* The primary efficacy endpoint will be assessed at Week 12 of treatment. Efficacy assessment will be limited to the face\n* The study will be conducted at approximately 15 study sites\n* 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",[80,86],{"label":81,"type":82,"description":83,"interventionNames":84},"B244 Suspension O.D. 5.0","EXPERIMENTAL","One arm of 88 Subjects will be receiving a dose of B244 O.D. 5.0 suspension",[85],"Biological: B244",{"label":87,"type":88,"description":89,"interventionNames":90},"Placebo","PLACEBO_COMPARATOR","Second arm of 88 subjects will receive a vehicle dosing",[91],"Biological: Vehicle",[93,98],{"type":94,"name":95,"description":96,"armGroupLabels":97,"otherNames":68},"BIOLOGICAL","B244","B244 suspension",[81],{"type":94,"name":99,"description":100,"armGroupLabels":101,"otherNames":68},"Vehicle","Vehicle suspension",[87],[103],{"name":104,"affiliation":5,"role":105},"Hyun Kim, PhD","STUDY_DIRECTOR",[107,111],{"name":104,"role":108,"phone":109,"phoneExt":68,"email":110},"CONTACT","781-439-7159","hkim@aobiome.com",{"name":112,"role":108,"phone":68,"phoneExt":68,"email":113},"Connie Li, MEng","connie@aobiome.com",{"type":115,"investigatorFullName":68,"investigatorTitle":68,"investigatorAffiliation":68,"oldNameTitle":68,"oldOrganization":68},"SPONSOR",[117],{"name":118,"class":6},"bioRASI, LLC","100659485","phase-2-study-to-determine-efficacy-safety-and-tolerability-of-b244-as-a-topical-spray-in-subjects-with-moderate-to-severe-acne-vulgaris-100659485",false,"NCT07866105","Study to Determine Efficacy, Safety, and Tolerability of B244 as a Topical Spray in Subjects With Moderate to Severe Acne Vulgaris","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","Inclusion Criteria:\n\n1. Males and females age 12 years and older\n2. Participants (and\u002For parents or guardians) willing and able to provide informed consent\u002Fassent and to comply with the study protocol\n3. Clinical diagnosis of moderate to severe facial acne vulgaris defined as the following at Screening and Baseline:\n\n   1. IGA 3-4, and;\n   2. ≥20 to ≤100 inflammatory lesions (papules, pustules, nodules), and;\n   3. ≥30 to ≤150 non-inflammatory lesions (open comedones or blackheads, closed comedones or whiteheads), and\n   4. ≤2 nodules, and\n   5. 0 cysts\n4. Willing to refrain from using any acne treatments other than the investigational product for the duration of the study\n5. Willing and able to complete once-daily eDiary entries within a consistent timeframe for the duration of the study\n6. Judged to be in good health in the Investigator's opinion\n7. Ability and willingness to abstain from taking medications not allowed by the protocol for the duration of the study\n\nExclusion Criteria:\n\n1. 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\n2. Use of oral\u002Fsystemic 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\u002Fday within 4 weeks prior to randomization to end of follow-up, and zinc within 4 weeks prior to randomization to end of follow-up\n3. Use of oral\u002Fsystemic androgen receptor blockers (such as spironolactone, flutamide, cyproterone acetate, or bicalutamide) within 3 months prior to randomization to end of follow-up\n4. Use of topical androgen receptor blockers (such as clascoterone) within 4 weeks prior to randomization to end of follow-up\n5. 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\n6. Use of systemic corticosteroids within 4 weeks prior to randomization to end of follow-up\n7. Any clinically significant changes in type, dose, or frequency of bland emollients throughout the study from screening to follow-up\n8. 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\n9. Treatment with systemic immunosuppressive\u002F immunomodulatory therapies within 4 weeks prior to randomization (including but not limited to cyclosporine, mycophenolate-mofetil, methotrexate, azathioprine, interferon gamma)\n10. Use of medications known to cause or exacerbate acneiform eruptions including lithium, anabolic steroids, adrenocorticotropic hormone, halogenated compounds, phenytoin, JAK\u002FTYK-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\n11. 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\n12. 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\n13. Treatment with any investigational therapy within 4 weeks prior to randomization to end of follow-up\n14. Allergen immunotherapy within 6 months prior to randomization to end of follow-up\n15. Use of acne-specific skin care products within 2 weeks prior to randomization to end of follow-up\n16. Use of traditional Chinese medicine for acne within 2 weeks prior to randomization to end of follow-up\n17. 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\n18. Concurrent skin diseases affecting efficacy evaluation (e.g., dermatitis, psoriasis, rosacea)\n19. Nodulocystic acne, secondary acne (e.g., occupational or steroid- induced acne, chloracne, acne mechanica), acne conglobata, acne fulminans, or any other acne variant\n20. Facial hair hindering acne assessment\n21. 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\n22. 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)\n23. 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\n24. History of a major psychiatric condition (including major depressive disorder, bipolar disorder, or schizophrenia), suicidal ideation, or suicide attempt\n25. Known active hepatitis infection\n26. Known history of human immunodeficiency virus (HIV) infection\n27. 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\n28. Currently pregnant or breastfeeding, or male participant with a pregnant or breastfeeding partner\n29. 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\n30. The participant has been previously randomized in this study\n31. Inability to give informed consent","ALL","12 Years",{"count":129,"type":130},176,"ESTIMATED","INTERVENTIONAL",[133],"PHASE2","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.",[136],"Acne Vulgaris","NOT_YET_RECRUITING","2026-10-05",{"date":140,"type":141},"2026-10-08","ACTUAL",{"date":143,"type":130},"2026-10",{"date":145,"type":130},"2027-09",{"name":5,"class":6}]