[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"acne-vulgaris-on-the-face\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:acne-vulgaris-on-the-face":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100572144","efficacy-and-tolerability-of-dispersinb-acne-cleanser-in-the-treatment-of-mild-to-moderate-acne-vulgaris-100572144",false,"NCT06729450","Efficacy and Tolerability of DispersinB Acne Cleanser in the Treatment of Mild to Moderate Acne Vulgaris","Split-face Efficacy and Tolerability of DispersinB Acne Cleanser in the Treatment of Mild to Moderate Acne Vulgaris","Inclusion Criteria:\n\n1. Male or female subject aged 18 years or older, at screening visit.\n2. Subject with clinical diagnosis of acne vulgaris on the face as defined by Investigator's Global Assessment (IGA) score of 2 (Mild) or 3 (Moderate), with the same score on both sides of the face.\n3. Subject with a symmetrical number of lesions on the whole face.\n4. The subject is a female of childbearing potential is willing to undergo UPTs throughout the study.\n5. Subject having read, understood, and signed the approved Informed Consent Form (ICF) prior to any participation in the study.\n6. Subject agrees and is able to comply with all time commitments and procedural requirements of the protocol.\n7. Subject agrees to having facial photographs taken and verified by the subject signing an approved photography ICF.\n8. Subject is informed of terms pertaining to personal information protection and privacy and is willing to share personal information and data, as verified by signing a written authorization form.\n\nExclusion Criteria:\n\n1. Subject with acne types other than acne vulgaris.\n2. Subject with dermal conditions on the face that may interfere with study assessments in the opinion of the investigator (tattoo, skin abrasion, eczema, sun burn, scars, large nevi, etc.).\n3. Subject with excessive facial hair that would interfere with study assessments, as judged by the investigator.\n4. Pregnant women (positive urine pregnancy test at screening or baseline) or women planning pregnancy during the study.\n5. Subjects taking Vitamin A supplements in excess of the recommended daily allowance (4000-5000 IU; no washout period is required).\n6. Subject with a washout period for topical treatment or procedures on the face less than:\n\n   1. Topical treatments: corticosteroids, antibiotics, azelaic acid, alpha hydroxy acids, salicylic acid, zinc containing treatments, hydroquinones, and other anti-acne treatments - 2 weeks\n   2. Topical retinoids - 2 weeks\n   3. Calascoterone cream 1% - 2 weeks\n   4. Cosmetic\u002Faesthetic procedures (e.g., comedo extraction, desquamating, or abrasive agents, adhesive \"pore\" cleansing strips) - 1 week\n   5. Wax epilation - 2 weeks\n   6. Photodynamic therapy - 4 weeks\n   7. Laser therapy, microdermabrasion, deep chemical peel, and other plastic surgical treatments for acne - 12weeks\n7. Subject with a washout period for systemic treatment less than:\n\n   1. Corticosteroids (except locally acting such as inhaled or intrathecal), antibiotics, and spironolactone - 4 weeks\n   2. Oral retinoids\u002Fisotretinoin - 12 weeks\n   3. Cyproterone acetate\u002FChlomadinone acetate - 12 weeks\n   4. Immunomodulators - 12 weeks\n8. Subject is currently receiving any prescription testosterone therapy or on a testosterone booster or supplements.\n9. The subject is unwilling or unable to refrain from use of prohibited medication or procedures during the study.\n10. Subject who will experience intensive ultraviolet exposure during the study (sunbathing, tanning beds, etc.).\n11. Subject with an acute\u002Fchronic disease or a history of major medical, surgical, or psychiatric condition or surgical interventions that may interfere with the interpretation of the study results.\n12. Study site personnel or employees\u002Fclose relatives of the study Sponsor.\n13. Subject who has participated in another investigational treatment study within 30 days prior to screening.\n14. Subject with a history of alcohol\u002Fdrug abuse.\n15. Subject who is unable to communicate or cooperate with the investigator due to language problems or impaired cognitive\u002Fverbal function.\n16. Subject is currently incarcerated.","ALL","18 Years",{"count":19,"type":20},24,"ESTIMATED","INTERVENTIONAL",[23],"NA","This is a single-center study using intra-individual comparison (right half-face versus left half-face) to evaluate the efficacy and tolerability of DispersinB Acne Cleanser for treatment of acne in adults. An initial sample size of 24 subjects is planned to be randomized in order to provide proof of concept efficacy and tolerability of the product.\n\nThe main questions it aims to answer are:\n\n1. Percent of subjects rated \"Clear\" and \"Almost Clear\" on a 5-point scale 0=clear; 4=severe) at 12 weeks\n2. Change in inflammatory and noninflammatory lesion count per half-face at 12 weeks\n\nResearchers will compare each half-face:\n\n* one half facial wash with DispersinB Acne Cleanser and 4% Benzoyl Peroxide.\n* one half facial wash with 4% Benzoyl Peroxide only\n\nSubjects will use the DispersinB Acne Cleanser on the assigned facial side for 5 minutes and then will use the provided 4% Benzoyl peroxide facial wash to wash entire face for daily (evening) use.",[26],"Acne Vulgaris on the Face",[28,29],"acne","dermatosis","NOT_YET_RECRUITING","2025-05-08",{"date":33,"type":34},"2025-05-13","ACTUAL",{"date":36,"type":20},"2026-01-30",{"date":38,"type":20},"2026-12-16",{"name":40,"class":41},"Kane Biotech Inc","INDUSTRY",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":51,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":42},"100585657","phase-3-study-of-new-antiandrogenic-progestogen--low-dose-estrogen-for-moderate-acne-vulgaris-100585657","NCT06905210","Study of New Antiandrogenic Progestogen + Low-dose Estrogen for Moderate Acne Vulgaris","Phase III Superiority, Randomized, Double-blind, Placebo-controlled, Adaptive, Multicenter Study to Compare the Efficacy and Safety of a New Concentration of an Antiandrogenic Progestogen Combined With a Reduced-dose Estrogen for the Treatment of Moderate Acne Vulgaris","PANDORA","Inclusion Criteria:\n\n1. Ability to confirm voluntary participation and agree to all trial procedures by signing the Informed Consent Form (ICF) and Informed Assent Form (ITA), if applicable, prior to any procedure provided for in the protocol. Note: The adult participant or the participant's guardian when the participant is a legal minor (adolescent) must sign the ICF after understanding and agreeing to all trial procedures. The adolescent participant must provide assent by signing the ITA based on local regulations and\u002For guidelines prior to the start of any study procedures.\n2. Female sex.\n3. Age between 14 and 45 years (inclusive).\n4. At least one year after menarche.\n5. At least one menstrual period during the last 03 months.\n6. Absence of known contraindications for the use of combined oral contraceptives. 7. Diagnosis of moderate acne vulgaris on the face for at least six months, characterized by the presence of:\n\nNote: Information regarding the duration of the disease can be obtained from the clinical history reported by the participant or from a brief medical report of the participant's history, if she is referred from another service.\n\n1. At least 15 inflammatory lesions (papules or pustules);\n2. At least 10 non-inflammatory lesions (comedones); and\n3. Up to 03 small inactive nodules. Note: Nodules are lesions between 10 and 30 mm, more palpable than visible.\n\n   8\\. Classification ≥ 3 on the 6-point scale of the Investigator's Static Global Assessment (ISGA).\n\n   9\\. When the participant did not obtain adequate results with topical treatment, failure or impossibility of systemic treatment with antibiotics (contraindications or intolerance) and the patient has an indication for the use of antiandrogens and\u002For isotretinoin.\n\n   10\\. Agreement not to use other topical and\u002For systemic treatments for acne during the study.\n\nExclusion Criteria:\n\n1\\. Confirmed or suspected pregnancy. 2. History of childbirth, abortion or lactation in the last 3 months. 3. Participants who do not agree to use non-hormonal contraceptive methods permitted during the study, unless they are surgically sterile or who expressly declare themselves to be free from risk of pregnancy because they do not engage in sexual practices or engage in them in a non-reproductive manner.\n\n4\\. Current or previous treatment with agents described below with a washout period shorter than that provided for each:\n\n1. At least 6 months for systemic isotretinoin and\u002For injectable contraceptive (such as Depo Provera);\n2. At least 3 months for implantable contraceptives (such as Implanon) or Levonorgestrel-Releasing Intrauterine System (such as Mirena and Kyleena);\n3. At least 2 months for oral contraceptives or other systemic anti-acne agents not mentioned (such as systemic antibiotics);\n4. At least 4 weeks for topical retinoids;\n5. At least 2 weeks for other topical anti-acne agents (such as topical antibiotics or benzoyl peroxide); 5. Personal history or first-degree family history of vascular disease including previous arterial thromboembolic disease (myocardial infarction or stroke), venous thromboembolic disease (peripheral venous thrombosis or pulmonary embolism) or any condition that increases the risk for any of the previous conditions.\n\n   6\\. Known personal history of thrombophilia. 7. Current smoking. 8. Any disease or condition that compromises the function of body systems that would result in altered absorption, excessive accumulation, impaired metabolism or altered excretion of the study medication, including malabsorptive conditions (such as previous bariatric surgery).\n\n   9\\. Any condition that worsens under hormonal treatment or that interferes with the conduct of the study or interpretation of the results, such as gestational herpes or idiopathic jaundice during previous pregnancy, otosclerosis, Sydeham's chorea, porphyria, bile flow disorders (presence or history of cholestasis, gallstones, systemic lupus erythematosus).\n\n   10\\. Other comorbidities (history or current diagnosis) such as chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis), hemolytic uremic syndrome, headache with focal neurological symptoms, epilepsy, asthma with chronic use of oral corticosteroids, multiple sclerosis, Chorea minor, tetany, endometriosis, mastopathy, current premenstrual dysphoric disorder, sickle cell anemia, pancreatitis, vascular complications of diabetes, major depressive disorder or other conditions that, in the investigator's assessment, may compromise the participant's safety.\n\n   11\\. Hypersensitivity to any of the components of the experimental drug or placebo.\n\n   12\\. Presence of moderate to severe atopy, acne comedonica or acne conglobata, induced acne or acne with multiple large nodules, cysts, fistular comedones or fistular duct abscess or other dermatological conditions that, in the investigator's assessment, may compromise the evaluation of efficacy.\n\n   13\\. Use of comedogenic creams or sunscreens, other preparations with sex hormones or any other anti-acne therapy (such as phototherapy, oleic acids, chemical peeling, mechanical extraction of comedones).\n\n   14\\. Preparations with acnegenic effects, such as iodinated or brominated drugs, tuberculostatics, lithium, vitamins B1 (\\> 1.5 mg\u002Fday), B6 (\\> 2 mg\u002Fday) or B12 (\\> 6 g\u002Fday), corticosteroids, adrenocorticotropic hormone (ACHT), anabolic steroids, quinine, disulfiram, methoxypsoralen, phenobarbital, phenytoin, trimethadione, thyroid depressants, certain oily cosmetics.\n\n   15\\. History of drug abuse. 16. History of neoplasia in the last 5 years, except non-melanoma skin cancer, or any history of sex hormone-dependent neoplasia or current suspicion of neoplasia, including meningioma.\n\n   17\\. Use of other medications that interfere with hepatic metabolism via cytochrome P450, such as carbamazepine, phenytoin, primidone, oxcarbazepine, topiramate, rifampicin, ritonavir and products containing St. John's wort.\n\n   18\\. Use of direct-acting antiviral medications containing ombitasvir, paritaprevir or dasabuvir and combinations of these medications.\n\n   19\\. Undiagnosed vaginal bleeding. 20. Change in clinical breast examination or other clinically significant finding on gynecological examination that could, in the opinion of the investigator, be worsened by oral contraceptives. 21. Absence of proof of a Pap smear (oncotic cytology) without changes suspicious of malignancy in the last 12 months. Note: If the participant does not have a previous exam within the accepted interval and agrees, the exam may be performed at the Selection Visit (VS\u002FV1).\n\n   22\\. Absence of proof of a bilateral mammogram without changes suspicious of malignancy in the last 12 months, only for participants aged ≥ 40 years. Note: Mammograms with suspicious of malignancy are considered 23. Obesity (BMI \\> 30 kg\u002Fm²). 24. Uncontrolled arterial hypertension (Systolic Blood Pressure \\[SBP\\] ≥140 mmHg or Diastolic Blood Pressure \\[DBP\\] ≥ 90 mmHg).\n\n   25\\. Participant who has participated in clinical trial protocols in the last 12 (twelve) months, unless the investigator believes that there may be direct benefit to the participant.\n\n   26\\. Participant who, in the opinion of the investigator, presents other clinical or laboratory conditions or alterations that make him\u002Fher unfit to participate in the study","FEMALE","14 Years","45 Years",{"count":55,"type":20},526,[57],"PHASE3","This Phase III randomized, double-blind, placebo-controlled, adaptive, multicenter study evaluates the efficacy and safety of a new concentration of the fixed-dose combination EF190 in women with moderate acne vulgaris over six 28-day treatment cycles. Eligible participants will be randomized (2:1) to receive either the experimental drug or placebo alongside standard skincare. The study includes five in-person visits (screening, randomization, and three follow-ups) and three phone contacts (cycles 2, 4, and 5) to monitor adherence, adverse events, and contraceptive use. A subgroup will undergo additional exploratory assessments, including acne questionnaires, ovarian activity tests, photographic documentation, and specialized lab\u002Fultrasound exams.",[60,26],"Acne Vulgaris",[62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77],"Acne treatment","fixed-dose combination","moderate acne","randomized controlled trial","women's dermatology","adaptive clinical study","efficacy & safety evaluation","hormonal acne research","Moderate acne vulgaris","Phase III","Randomized","Double-blind","Placebo-controlled","Adaptive design","Multicenter","Superiority trial","2025-04-01",{"date":80,"type":34},"2025-04-04",{"date":82,"type":20},"2026-03",{"date":84,"type":20},"2027-03",{"name":86,"class":41},"Eurofarma Laboratorios S.A."]