[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07524946":3,"trial-entities:NCT07524946":327,"trial-summary:NCT07524946":331},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":41,"secondary_outcomes":56,"sex":57,"minimum_age":58,"maximum_age":59,"healthy_volunteers":15,"eligibility_criteria":60,"std_ages":76,"locations":78,"central_contacts":315,"overall_officials":324,"references":325,"see_also_links":326},"NCT07524946","V01-126A-401","Study to Assess Safety, Pharmacokinetics, and Treatment Effect of Cabtreo","A 12-Week, Phase 4, Open-Label Study To Assess Safety, Pharmacokinetics, and Treatment Effect of CABTREO (Clindamycin Phosphate 1.2%, Adapalene 0.15%, and Benzoyl Peroxide 3.1%) Topical Gel In Pediatric Participants Ages 9 to 11 Years, 11 Month With Acne Vulgaris","RECRUITING","2027-12","2026-07","2026-07-29","2026-04-01","Bausch Health Americas, Inc.","INDUSTRY",false,"This study is to evaluate the safety, pharmacokinetics, and treatment effect for topically applied CABTREO lotion in pediatric participants ages 9 to 11 years, 11 months with Acne Vulgaris.","This is an open-label study designed to assess the safety, plasma PK, and treatment effect of topically applied CABTREO. This study includes both a main study and a PK sub-study. All participants will undergo a screening period of up to 5 weeks (up to 35 days) and a treatment period of up to 12 weeks (approximately 84 days). A subset of participants in the main study will be included in the PK sub-study. To be eligible for this study, participants must be between 9 years and 11 years, 11 months of age, inclusive, and have a clinical diagnosis of moderate to severe acne, defined as a score of 3 (moderate) or 4 (severe) on the Evaluator's Global Severity Score (EGSS). Participants must also have at least 30 facial acne inflammatory lesions, at least 35 facial acne noninflammatory lesions, and no more than 2 facial nodules; participants should also have acne lesions on at least 1 region of the trunk (chest, back, and\u002For shoulder).",[19],"Acne Vulgaris",[21,22,23,19,24],"Pediatric","Open-Label","Cabtreo","Topical","INTERVENTIONAL","TREATMENT",[28],"PHASE4",{"count":30,"type":31},100,"ESTIMATED",[33],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":39},"DRUG","CABTREO is a fixed-combination product of clindamycin phosphate 1.2%\u002FBPO 3.1%\u002Fadapalene 0.15%.","The study drug will be applied topically to the treatment areas at home, each the morning, for a period of 12 weeks, with the exception of study visit days (baseline \\[Day 1\\], and Days 14, 15 \\[PK substudy only\\], 28, 29 \\[PK substudy only\\], 56, and 84) where study drug will be applied by the participants after the study visit is completed at the study center. The study drug will be applied as a thin coating that is gently rubbed into the skin.",[38],"All enrolled participants will receive CABTREO in this open-label study.",[40],"IDP-126",[42,46,50,53],{"measure":43,"description":44,"timeFrame":45},"Incidence of Treatment-Emergent Adverse Events","Starting after signing the informed consent\u002Fassent document, and continuing through the end of the study, participants will be assessed for the occurrence of new AEs and changes in ongoing AEs. The descriptions of all AEs will include the dates of onset and resolution (if resolved), maximum severity, seriousness, action taken regarding the study drug, corrective treatment, outcome, and the investigator's assessment of causality. Worsening of disease will not be considered an AE unless it results in discontinuation of the participant from the study or requires medical intervention prohibited by the protocol. All AEs will be followed to resolution or until stable, as determined by the investigator.","All AEs will be followed from onset of the adverse event through the end of Study Week 12 visit",{"measure":47,"description":48,"timeFrame":49},"Change in Inflammatory Lesions","Changes from Baseline to each study visit in inflammatory lesion counts","Baseline through Week 12",{"measure":51,"description":52,"timeFrame":49},"Change in Non-inflammatory Lesions","Changes from Baseline to each study visit in non-inflammatory lesion counts",{"measure":54,"description":55,"timeFrame":49},"EGSS Results","Collection of EGSS results from Baseline visit through end of study Week 12",[],"ALL","9 Years","11 Years",{"inclusion":61,"exclusion":74,"raw_text":75},[62,63,64,65,66,67,68,69,70,71,72,73],"Topical astringents and abrasives (including comedo removal strips) on the face -1 week","Nonallowed moisturizers or sunscreens on the face -1 week","Antibiotics on the face -2 weeks","Other topical anti-acne drugs on the face -2 weeks","Soaps containing antimicrobials on the face -2 weeks","Anti-inflammatory agents and corticosteroids on the face -4 weeks","Retinoids, including retinol, on the face -4 weeks","Facial procedures, including chemical peel, microdermabrasion, light (eg, PDT, LED) and laser therapy, and acne surgery -4 weeks 16. Participants who have not undergone the specified washout period(s) for the following systemic medications or participants who require the concurrent use of any of the following systemic medications:","Corticosteroids (including intramuscular injections) (inhaled corticosteroids allowed) -4 weeks","Antibiotics -4 weeks","Other systemic acne treatments -4 weeks","Systemic retinoids -6 months 17. Participants who intend to use a tanning booth or sunbathe during the study 18. Participants who are unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function 19. Participants who have any underlying disease the investigator deems uncontrolled, and that poses a concern for the participant's safety while participating in the study",[],"Inclusion Criteria:\n\nA participant will be eligible for inclusion if he\u002Fshe meets all the following criteria:\n\n1. Male or female participants, ≥ 9 years of age and ≤ 11 years, 11 months of age at baseline\n2. Participants must provide verbal and signed, written informed consent; participants less than the age of consent must sign an assent for the study and a parent\u002Flegal guardian must sign the informed consent\n3. Participants must have a score of 3 (moderate) or 4 (severe) on the EGSS assessment at baseline\n4. Participants must have a facial acne inflammatory lesion (papules, pustules, and nodules) count ≥ 30 at baseline\n5. Participants must have a facial acne noninflammatory lesion (open and closed comedones) count ≥ 35 at baseline\n6. Participants must have acne lesions in at least 1 truncal region (ie, on the chest, back, and\u002For shoulder) at baseline\n7. Participants must have ≤ 2 facial nodules at baseline\n8. Women of childbearing potential and female participants who are premenses (≥ 9 years of age) must be willing to practice effective contraception for the duration of the study.\n\n   Effective contraception is defined as being stabilized on an oral contraceptive for at least 3 months; using an intrauterine device\u002Fsystem, condom with spermicide, diaphragm with spermicide, implant, NuvaRing®, injection, transdermal patch; bilateral tubal ligation; vasectomized partner; or practicing abstinence. Females on birth control pills must have taken the same type of pill for at least 3 months prior to entering the study and must not change types during the study. Those who have used birth control pills in the past must have discontinued use at least 3 months prior to the start of the study. Those who use birth control for acne control only should be excluded.\n9. Premenses females and women of childbearing potential must have a negative urine pregnancy test at screening and baseline, and must have a negative serum pregnancy test at screening.\n10. Participants must be willing to comply with study instructions and return to the study center for required visits; participants under the age of consent must be accompanied by the parent\u002Flegal guardian at the time of providing assent\u002Fconsent\n11. If a cleanser, moisturizer or sunscreen is needed during the study, participants must be willing to use only allowed cleansers, moisturizers, sunscreens, or moisturizer\u002Fsunscreen combination products; the participant must agree to use noncomedogenic products (including makeup and shaving products) Use of an investigational drug or device within 30 days of enrollment or participation in a research study concurrent with this study\n\nExclusion Criteria:\n\nA participant will not be eligible for inclusion if any of the following criteria apply:\n\n1. Use of an investigational drug or device within 30 days of enrollment or participation in a research study concurrent with this study\n2. Any dermatological conditions on the face that could interfere with clinical evaluations such as acne conglobata, acne fulminans, secondary acne, perioral dermatitis, clinically significant rosacea, gram-negative folliculitis, dermatitis, and\u002For eczema\n3. Any underlying disease(s) or other dermatological condition of the face that requires the use of interfering topical or systemic therapy, or makes evaluations and lesion counts inconclusive\n4. Participants with \\> 2 facial nodules at baseline\n5. Evidence or history of cosmetic-related acne\n6. Participants with a history of experiencing significant burning or stinging when applying any facial treatment (eg, makeup, soap, masks, washes, sunscreens) to the face\n7. Female participants who are pregnant, nursing mothers, planning a pregnancy during the course of the study, or become pregnant during the study\n8. Use of estrogens (eg, Depogen, Depo-Testadiol, Gynogen, Valergen) for less than 12 weeks immediately preceding study entry; a participant who is treated with estrogens for ≥ 12 consecutive weeks immediately prior to study entry need not be excluded unless the participant expects to change the dose, the drug, or discontinue estrogen use during the study\n9. If female, participant has a history of hirsutism, polycystic ovarian disease, or clinically significant menstrual irregularities\n10. History of regional enteritis, ulcerative colitis, inflammatory bowel disease, pseudomembranous colitis, chronic or recurrent diarrhea, or antibiotic-associated colitis\n11. Treatment of any type of cancer within the 6 months prior to screening, with the exception of complete surgical excision of skin cancer outside the treatment area\n12. Participant uses medications and\u002For vitamins during the study that are reported to exacerbate acne (azathioprine, haloperidol, Vitamin D, Vitamin B12, halogens such as iodides or bromides, lithium, systemic or topical mid- to super-high potency corticosteroids on the treatment area, phenytoin, and phenobarbital); multivitamins, including Vitamin A, at recommended daily doses, and Vitamin D at stable doses, are acceptable\n13. History of hypersensitivity or allergic reactions to any of the study preparations as described in the Investigator's Brochure, including known sensitivities to any dosage form of clindamycin phosphate, BPO, or adapalene\n14. Concomitant use of potentially irritating over the counter products that contain ingredients such as BPO, alpha-hydroxy acid, salicylic acid, retinol, or glycolic acids\n15. Participants who have not undergone the specified washout period(s) for the following topical preparations or physical treatments used on the face or participants who require the concurrent use of any of the following topical agents in the treatment area:\n\n    * Topical astringents and abrasives (including comedo removal strips) on the face -1 week\n    * Nonallowed moisturizers or sunscreens on the face -1 week\n    * Antibiotics on the face -2 weeks\n    * Other topical anti-acne drugs on the face -2 weeks\n    * Soaps containing antimicrobials on the face -2 weeks\n    * Anti-inflammatory agents and corticosteroids on the face -4 weeks\n    * Retinoids, including retinol, on the face -4 weeks\n    * Facial procedures, including chemical peel, microdermabrasion, light (eg, PDT, LED) and laser therapy, and acne surgery -4 weeks\n16. Participants who have not undergone the specified washout period(s) for the following systemic medications or participants who require the concurrent use of any of the following systemic medications:\n\n    * Corticosteroids (including intramuscular injections) (inhaled corticosteroids allowed) -4 weeks\n    * Antibiotics -4 weeks\n    * Other systemic acne treatments -4 weeks\n    * Systemic retinoids -6 months\n17. Participants who intend to use a tanning booth or sunbathe during the study\n18. Participants who are unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function\n19. Participants who have any underlying disease the investigator deems uncontrolled, and that poses a concern for the participant's safety while participating in the study",[77],"CHILD",[79,97,112,125,140,156,171,187,203,219,235,250,267,283,299],{"facility":80,"status":8,"city":81,"state":82,"zip":83,"country":84,"contacts":85,"geoPoint":94},"Dermatology Trial Associates","Bryant","Arkansas","72002","United States",[86,91],{"name":87,"role":88,"phone":89,"email":90},"Dow Stough, MD","CONTACT","501-655-6138","dow@burketherapeutics.com",{"name":92,"role":88,"phone":89,"email":93},"Makenzie Mixon","mmixon@burkepharmaceutical.com",{"lat":95,"lon":96},34.59593,-92.48905,{"facility":98,"status":8,"city":99,"state":82,"zip":100,"country":84,"contacts":101,"geoPoint":109},"Northwest Arkansas Clinical Trials Center","Rogers","72758",[102,106],{"name":103,"role":88,"phone":104,"email":105},"Cheryl Hull, MD","479-876-8205","drhull@hullderm.com",{"name":107,"role":88,"phone":104,"email":108},"Olympia Marshall","omarshall@hullderm.com",{"lat":110,"lon":111},36.33202,-94.11854,{"facility":113,"status":8,"city":114,"state":115,"zip":116,"country":84,"contacts":117},"Center for Dermatology Clinical Research","Freemont","California","94538",[118,122],{"name":119,"role":88,"phone":120,"email":121},"Sunil Dhawan, MD","510-797-0140","sdhawan@centerforderm.com",{"name":123,"role":88,"phone":120,"email":124},"Mele Tupou","melet@ctr4derm.com",{"facility":126,"status":8,"city":127,"state":115,"zip":128,"country":84,"contacts":129,"geoPoint":137},"Ablon Skin Institute and Research Center","Manhattan Beach","90266",[130,134],{"name":131,"role":88,"phone":132,"email":133},"Glynis Ablon, MD","310-727-3376","drablon@abloninstitute.com",{"name":135,"role":88,"phone":132,"email":136},"Shelley Joyce","shelley@abloninstitute.com",{"lat":138,"lon":139},33.88474,-118.41091,{"facility":141,"status":8,"city":142,"state":143,"zip":144,"country":84,"contacts":145,"geoPoint":153},"Ziaderm Research, LLC","North Miami Beach","Florida","33162",[146,150],{"name":147,"role":88,"phone":148,"email":149},"Tory Sullivan, MD","305-652-8600","drtory@sullivandermatology.com",{"name":151,"role":88,"phone":148,"email":152},"Daine Velazco, MD","daine@sullivandermatology.com",{"lat":154,"lon":155},25.93315,-80.16255,{"facility":157,"status":8,"city":158,"state":143,"zip":159,"country":84,"contacts":160,"geoPoint":168},"Clinical Research Trials of Florida, Inc","Tampa","33607",[161,165],{"name":162,"role":88,"phone":163,"email":164},"Sady Alpizar, MD","813-873-8102","s.alpizar.md@crtfi.com",{"name":166,"role":88,"phone":163,"email":167},"Viviana Fonseca","viviana@crtfi.com",{"lat":169,"lon":170},27.94752,-82.45843,{"facility":172,"status":8,"city":173,"state":174,"zip":175,"country":84,"contacts":176,"geoPoint":184},"DS Research of Kentucky, LLC","Louisville","Kentucky","40241",[177,181],{"name":178,"role":88,"phone":179,"email":180},"Cindy Owen, MD","502-585-9059","cowen@dsrtrials.com",{"name":182,"role":88,"phone":179,"email":183},"Kaley Kidd","kkidd@dsresearch.com",{"lat":185,"lon":186},38.25424,-85.75941,{"facility":188,"status":8,"city":189,"state":190,"zip":191,"country":84,"contacts":192,"geoPoint":200},"Michigan Center for Skin Care Research","Clinton Township","Michigan","48038",[193,197],{"name":194,"role":88,"phone":195,"email":196},"Mary Veremis-Ley, MD","586-286-7325","mveremisley@docsdermgroup.com",{"name":198,"role":88,"phone":195,"email":199},"Kathleen Gesinski","kgesinski@skincareresearch.com",{"lat":201,"lon":202},42.58698,-82.91992,{"facility":204,"status":8,"city":205,"state":206,"zip":207,"country":84,"contacts":208,"geoPoint":216},"JDR Dermatology Research","Las Vegas","Nevada","89145",[209,213],{"name":210,"role":88,"phone":211,"email":212},"James Del Rosso, MD","702-331-4123","jqdelrosso@yahoo.com",{"name":214,"role":88,"phone":211,"email":215},"Lupe Barrera","Gb.drdr@gmail.com",{"lat":217,"lon":218},36.17497,-115.13722,{"facility":220,"status":8,"city":221,"state":222,"zip":223,"country":84,"contacts":224,"geoPoint":232},"DermResearchCenter of New York","Stony Brook","New York","11790",[225,229],{"name":226,"role":88,"phone":227,"email":228},"Elyse Rafal, MD","631-689-1900","erafal@dcny.com",{"name":230,"role":88,"phone":227,"email":231},"Carolyn Thanasoulis","cthanasoulis@drcny.com",{"lat":233,"lon":234},40.92565,-73.14094,{"facility":236,"status":8,"city":237,"state":222,"zip":238,"country":84,"contacts":239,"geoPoint":247},"Vitality Clinical Trials, LLC","Woodbury","11797",[240,244],{"name":241,"role":88,"phone":242,"email":243},"Jeffrey Sklar, MD","917-647-3830","jeffrey.sklar@vitalityclinicaltrials.com",{"name":245,"role":88,"phone":242,"email":246},"Melody Dalessandro","melody.dalessandro@vitalityclinicaltrials.com",{"lat":248,"lon":249},41.36454,-74.10598,{"facility":251,"status":252,"city":253,"state":254,"zip":255,"country":84,"contacts":256,"geoPoint":264},"Flourish Research Acquisition, LLC","NOT_YET_RECRUITING","Apex","North Carolina","70471",[257,261],{"name":258,"role":88,"phone":259,"email":260},"Martha Stewart, MD","985-900-2400","mstewartmd@clinicaltrialsmgt.com",{"name":262,"role":88,"phone":259,"email":263},"Sandi Bailey","sbailey@flourishresearch.com",{"lat":265,"lon":266},35.73265,-78.85029,{"facility":268,"status":8,"city":269,"state":270,"zip":271,"country":84,"contacts":272,"geoPoint":280},"Lynn Health Science Institute","Oklahoma City","Oklahoma","73112",[273,277],{"name":274,"role":88,"phone":275,"email":276},"Carl Griffin, MD","405-602-3927","Cgriffin@lhsi.net",{"name":278,"role":88,"phone":275,"email":279},"Dalia Tover","Dtovar@lhsi.net",{"lat":281,"lon":282},35.46756,-97.51643,{"facility":284,"status":8,"city":285,"state":286,"zip":287,"country":84,"contacts":288,"geoPoint":296},"Cyn3rgy Research Corporation","Gresham","Oregon","97030",[289,293],{"name":290,"role":88,"phone":291,"email":292},"Frank Calcagno, MD","503-907-2179","fcalcagno@cyn3rgy.com",{"name":294,"role":88,"phone":291,"email":295},"Danille Frazen","dfranzen@cyn3rgy.com",{"lat":297,"lon":298},45.49818,-122.43148,{"facility":300,"status":8,"city":301,"state":302,"zip":303,"country":84,"contacts":304,"geoPoint":312},"Breakaway Research Group","Spokane","Washington","99202",[305,309],{"name":306,"role":88,"phone":307,"email":308},"William Werschler, MD","509-343-3710","Werschler@breakaway-research.com",{"name":310,"role":88,"phone":307,"email":311},"Payton Heid","Pheid@breakaway-research.com",{"lat":313,"lon":314},47.65966,-117.42908,[316,320],{"name":317,"role":88,"phone":318,"email":319},"Emily N Hughes, MACPR","731-415-3174","Emily.Hughes@BauschHealth.com",{"name":321,"role":88,"phone":322,"email":323},"Alison Magnotti-Nagel, CCRA","908-541-8664","Alison.Magnotti-Nagel@bauschhealth.com",[],[],[],{"nct_id":4,"conditions":328,"biomarkers":330},[329],"Acne",[],{"nct_id":4,"found":332,"summary":333,"prompt_version":343},true,{"design":334,"status":335,"heading":336,"summary":337,"follow_up":338,"word_count":339,"commitments":340,"compensation":341,"drugs_mentioned":342},"This is an open-label study, meaning both you and the study team will know you are receiving CABTREO. It will involve approximately 100 participants.","completed","Study of CABTREO for Acne Vulgaris in Children","This study is looking at how safe and effective a topical lotion called CABTREO (a combination of clindamycin phosphate, BPO, and adapalene) is for children aged 9 to 11 years, 11 months who have acne vulgaris (common acne). Researchers will also study how the body processes CABTREO. The study aims to see if CABTREO reduces inflammatory and non-inflammatory acne lesions and to track any side effects. To join, you must be between 9 and 11 years, 11 months old and have moderate to severe acne on your face and body. The study is currently unclear on its recruitment status and plans to enroll 100 participants.","All side effects will be tracked from when they start until the end of the 12-week study visit.",105,"You would apply CABTREO lotion to your skin each morning for 12 weeks. There will be study visits at baseline, and on Days 14, 28, 56, and 84, with additional visits for a subset of participants on Days 15 and 29.","Not stated in the trial record.",[],"v2"]