[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Bausch Health Americas, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":231},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,45,75,113,141,165,183,208],{"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":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100625892","phase-3-study-to-evaluate-the-safety-and-efficacy-of-larsucosterol-in-participants-with-alcohol-associated-hepatitis-ah-100625892",false,"NCT07428538","Study to Evaluate the Safety and Efficacy of Larsucosterol in Participants With Alcohol-associated Hepatitis (AH)","RE-AHFIRM (RandomizEd Study of Larsucosterol in Alcohol-associated Hepatitis to Confirm saFety and effIcacy of tReatMent)","Inclusion Criteria-\n\nA participant will be eligible for inclusion in this study if he\u002Fshe meets all the following criteria:\n\n1. Able to provide written informed consent (either from participant or participant's legally acceptable representative).\n2. Onset of jaundice within 8 weeks before hospital admission.\n3. Average daily consumption of greater than (\\>) 40 (females) or \\>60 (males) grams alcohol for 6 months or longer, with less than (\\\u003C) 8 weeks of abstinence before the onset of jaundice. Judgment regarding daily and long-term alcohol use and onset of jaundice will be made and documented by the site Investigator.\n4. The determination of AH will be based on typical serum chemistry (as determined by local laboratory):\n\n   1. Serum total bilirubin \\>3.0 milligrams per deciliter (mg\u002FdL) (required at randomization)\n   2. ALT \\\u003C400 international unit per Liter (IU\u002FL) (required at randomization)\n   3. 50 \\\u003CAST \\\u003C400 IU\u002FL\n   4. AST \\\u003C400 IU\u002FL (required at randomization)\n   5. AST \\>50 IU\u002FL (at any time since current hospital admission or leading to this current hospitalization)\n   6. AST\u002FALT \\>1.5 (at any time since current hospital admission or leading to this current hospitalization)\n5. Maddrey discriminant function (MDF) \\>=32, assuming a control prothrombin time of 12 seconds.\n\n   NOTE: If a local laboratory's control time differs from 12 seconds, then the local laboratory's control time should be used. If control time is not stated or is stated as a range, the control time should be calculated by the formula prothrombin time\u002FINR.\n6. Original Model for End-stage Liver Disease (MELD; not MELD-Na) score: 21-30 (inclusive).\n7. Male or female participants 18 years of age or older.\n8. Women of child-bearing potential (defined as females who are not surgically sterile or who are not over the age of 52 and amenorrheic for at least 12 months) must utilize appropriate birth control throughout the 90-day portion of the study. Acceptable methods that may be used are abstinence, birth control pills (\"The Pill\") or patch, diaphragm, IUD (coil), vaginal ring, condom, surgical sterilization or progestin implant or injection, or sexual activity limited to a sterile (e.g., vasectomized) male partner.\n9. Male participants must agree to use a medically acceptable method of contraception\u002Fbirth control and refrain from sperm donation throughout the 90-day portion of the study.\n10. Participants must agree to participate in an alcohol abstinence support program recommended by the local institution's addiction specialists.\n11. Participants must be dosed within 9 calendar days (216 hours) of hospital admission inclusive of time spent in other hospital(s)\n\nExclusion Criteria-\n\nA participant will be excluded from the study if he or she meets any of the following criteria:\n\n1. Participants using systemic corticosteroids for current AH before enrollment or having a history of using systemic corticosteroids for more than 8 days in the last 30 days prior to screening.\n\n   NOTE: Inhaled, topical, or local corticosteroid injections are permitted NOTE: A participant who has a confirmed diagnosis of hypoadrenalism and is taking a physiological replacement dose of hydrocortisone (or equivalent) is permitted to take part in the trial\n2. Participants experiencing or considered at high risk for alcohol withdrawal seizures or delirium tremens.\n3. Active infection (such as spontaneous bacterial peritonitis \\[SBP\\], urinary tract infection \\[UTI\\], cellulitis, pneumonia, bacteremia, acute viral hepatitis, uncontrolled HIV, and active SARS CoV2 infection).\n\n   1. Participants who are febrile with leukocytosis are also excluded until active infection has been excluded to the satisfaction of the PI in consultation with the medical monitor.\n   2. Participants with bacterial infections may be enrolled provided they remain in the enrollment window and the infection is adequately treated. For example, participants with bacterial peritonitis may be considered for enrollment once the infection has been treated and follow up paracentesis confirms the absence of SBP.\n   3. Participants with systemic fungal infection of any kind cannot be considered for this trial.\n4. Serum creatinine \\>2.5 mg\u002FdL.\n5. Participants undergoing continuous veno-venous hemodialysis (CVVH).\n6. Gastrointestinal bleeding not controlled by local therapy (i.e., band ligation or injection sclerotherapy). Participant who are at high risk of rebleeding or likely in need of TIPS insertion should be excluded.\n7. TIPS insertion or variceal embolization within the last 4 weeks.\n8. Known portal vein occlusion.\n9. A history of pre-admission refractory ascites defined as more than 4 paracenteses in the previous 8 weeks despite diuretic therapy.\n10. Liver biopsy (if carried out) with findings not compatible with AH. NOTE: A post-dose liver biopsy that is not compatible with AH will not be considered a protocol deviation.\n11. Stage \\>=3 hepatic encephalopathy by West Haven criteria.\n12. Participants with medical conditions that are expected to pose a high risk of short-term (less than or equal to \\[\\\u003C=\\] 90 days) mortality unrelated to alcohol-associated hepatitis, or that may confound assessment of 90-day survival in the Investigator's judgement. Examples include, but are not limited to:\n\n    1. Severe concomitant cardiopulmonary disease (e.g., New York Heart Association \\[NYHA\\] Class III or IV heart failure)\n    2. Clinically significant cardiac arrhythmia (e.g., sustained ventricular tachycardia, unmanaged atrial fibrillation, QTc \\>=500 msec, or high-grade AV block)\n    3. Ventilator-dependent respiratory failure, or Global Initiative for Chronic Obstructive Lung Disease \\[GOLD\\] Stage III or IV chronic obstructive pulmonary disease \\[COPD\\])\n    4. End-stage renal disease requiring chronic, ongoing dialysis\n    5. Severe uncontrolled endocrine or metabolic disorders\n    6. Severe psychiatric illness likely to interfere with study participation\n    7. Hypotension\u002Fshock as defined by the North American Consortium for the study of End-stage Liver Disease (NACSELD) criteria (i.e., Mean Arterial Pressure \\[MAP\\] \\\u003C60 millimeter of mercury (mmHg), despite adequate fluid resuscitation and cardiac output)\n13. Other concomitant cause(s) of liver disease as a result of:\n\n    1. Autoimmune liver disease\n    2. Ischemic hepatitis\n    3. Wilson disease or alpha 1 antitrypsin deficiency\n    4. Vascular liver disease (e.g., Budd-Chiari)\n    5. Drug induced liver disease\n    6. Surface antigen positive hepatitis B (HBsAg+). NOTE: Participants with isolated core antibody (anti-HBc) or who are on stable antiviral medication with known viral suppression are not excluded, but appropriate HBV prophylaxis should be considered if steroid dosing \\>4 weeks is anticipated.\n    7. Acute hepatitis A (if test performed per SOC)\n    8. Acute HCV or chronic hepatitis C with a history of decompensated cirrhosis. NOTE: participants with stable chronic HCV or successfully treated HCV are not excluded\n    9. Acute hepatitis E (if test performed per SOC)\n    10. Acute cytomegalovirus (CMV) viral hepatitis (if test performed per SOC)\n14. Any known active malignancy or any malignancy diagnosed within the last five years other than curable skin cancer (basal cell or squamous cell carcinomas).\n15. Existing or intended pregnancy or breast feeding.\n16. Participation in another interventional clinical trial within 30 days of Screening.\n17. History of organ transplantation other than corneal transplant.\n18. Underlying disease that, in the opinion of the site Investigator, might be complicated or exacerbated by proposed treatments or might confound assessment of study drug.\n19. Participant listed for liver transplant (LT) prior to study drug administration.\n20. Concern of participant's willingness and ability to be compliant with the schedule of protocol assessments, per the Investigator's judgement.","ALL","18 Years",{"count":19,"type":20},350,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","The primary purpose of this study is to evaluate the safety and efficacy of larsucosterol, as determined by transplant-free survival through Day 90 in participants with severe alcohol-associated hepatitis (AH) with pre-treatment Maddrey Discriminant Function (MDF) score greater than or equal to (\\>=) 32 and Model for End-stage Liver Disease (MELD) scores 21-30, inclusive.",[26],"Hepatitis",[28,29,30,31],"Alcoholic hepatitis","alcohol-associated liver disease (ALD)","Liver transplant (LT)","Alcohol-associated hepatitis (AH)","RECRUITING","2026-05-05",{"date":35,"type":36},"2026-05-07","ACTUAL",{"date":38,"type":36},"2026-01-29",{"date":40,"type":20},"2028-02",{"name":42,"class":43},"Bausch Health Americas, Inc.","INDUSTRY",48,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":4},"100633304","phase-4-study-to-assess-safety-pharmacokinetics-and-treatment-effect-of-cabtreo-100633304","NCT07524946","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","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","9 Years","11 Years",{"count":55,"type":20},100,[57],"PHASE4","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.",[60],"Acne Vulgaris",[62,63,64,60,65],"Pediatric","Open-Label","Cabtreo","Topical","NOT_YET_RECRUITING","2026-04-06",{"date":69,"type":36},"2026-04-13",{"date":71,"type":20},"2026-04",{"date":73,"type":20},"2027-12",{"name":42,"class":43},{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":16,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":4,"studyType":21,"phases":86,"briefSummary":87,"conditions":88,"keywords":92,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},"100614914","phase-4-rifaximin-200-mg-plus-oral-rehydration-vs-oral-rehydration-alone-in-children-with-acute-diarrhea-100614914","NCT07285785","Rifaximin 200 mg Plus Oral Rehydration vs Oral Rehydration Alone in Children With Acute Diarrhea","A Randomized, Open-Label Study to Assess Pharmacokinetics of Xifaxan® 200 mg in Pediatric Subjects 6 to 11 Years of Age With Acute Diarrhea of Suspected Bacterial Etiology, and the Safety and Efficacy of Xifaxan® 200 mg Plus Oral Rehydration Therapy (ORT) Compared to ORT Alone","Inclusion Criteria:\n\n1. Consent and assent are appropriately obtained prior to any study related activities, including discontinuation of any prohibited medications (subjects must sign an assent for the study and a parent or a legal guardian must sign the informed consent).\n2. Subject is between 6 to 11 (and 11 months) years of age, inclusive, and weighs at least 15 kg (33 lbs) at Screening.\n3. Females of childbearing (reproductive) potential must have a negative urine and serum pregnancy test at Screening and agree to use a highly effective method of contraception throughout their participation in the study. Acceptable methods of contraception are those alone or in combination, that result in a low failure rate (ie, less than 1% per year) when used consistently and correctly and include hormonal methods (oral, injected or implanted), intrauterine device or intrauterine system or double barrier methods (simultaneous use of a physical barrier method by the subject and male partner, including a male condom and an occlusive cap \\[diaphragm or cervical\u002Fvault cap\\] with spermicidal). Abstinence or partner(s) with a vasectomy may be considered an acceptable method of contraception at the discretion of the Investigator.\n\n   NOTE: Female subjects are considered of child-bearing potential if they are (a) physiologically capable of becoming pregnant, defined as a female who has experienced menarche and (b) they will be, or could possibly be, engaging in sexual activity during the course of the study.\n4. Subject has diarrhea of suspected bacterial etiology defined by:\n\n   * At least 3 unformed stools in the last 24 hours prior to Screening.\n   * A fever ≥ 100.4°F (38°C) and ≤ 102.2°F (39°C) or has had a fever of ≥ 100.4°F (38°C) and ≤ 102.2°F (39°C) at any time since the development of abdominal pain or diarrhea.\n   * Illness for less than 96 hours at Screening.\n5. Parent or legal guardian and subject, when applicable based on aged, are capable of understanding the requirements of the study and willing to comply with all study procedures and visits.\n\nExclusion Criteria:\n\n1. Subject has a history of chronic diarrhea.\n2. Subject is unable to eat or drink.\n3. Subject has at least one of the following signs or symptoms:\n\n   * Presence of fever \\>39°C (\\>102.2°F).\n   * Presence of frank blood in stool.\n4. Subject has taken \\>2 doses of anti-diarrheal therapies in the 24 hours prior to randomization.\n5. Subject has taken any oral antimicrobial drug within 14 days of randomization.\n6. Subject has an unstable medical condition, in the opinion of the Investigator, (including, but not limited to, evidence of severe dehydration noted by tachycardia, abnormal blood pressure, or decreased skin turgor) at the Screening visit.\n7. Subject has known, clinically significant hepatic disease manifested by twice the age and sex-adjusted upper limit of normal (2 × ULN) for any of the following liver function tests: alanine aminotransferase, aspartate aminotransferase, gamma-glutamyl transferase, alkaline phosphatase, or total bilirubin (except in isolated elevation of unconjugated bilirubin).\n8. Subject has known, clinically significant renal disease (eg, 1.5 × ULN of serum creatinine or 2 × ULN of blood urea nitrogen levels).\n9. Subject has serum sodium of ≥150 mEq\u002FL and serum potassium ≤3.0 mEq\u002FL.\n10. Subject has a known hypersensitivity or allergy to Xifaxan®, rifampin, rifamycin-derived antibiotics, or any of the components of the rifaximin (Xifaxan®) formulations used in this study.\n11. Subject is pregnant or lactating or plans to become pregnant during the study.\n12. Subject has had a previous history of malignancy.\n13. Subject has a history of tuberculosis infection and\u002For has received treatment for tuberculosis infection.\n14. Subject has any concurrent illness, disability or circumstance that may affect the interpretation of clinical data, could cause noncompliance with treatment or visits or otherwise contraindicates participation in this study in the opinion of the Investigator.\n15. Subject has had significant blood loss within the 30 days prior to the Screening visit which prevents the collection of the blood volume required for this study.\n16. Subject has participated in an investigational drug or device study within the 30 days prior to randomization.\n17. Subject's parent or legal guardian, or an immediate family member is an employee of the site that is directly involved in the management, administration, or support of this study.\n18. Subject and\u002For legal guardian is unwilling or unable to comply with the study protocol for any other reason.\n19. Subject has a serum glucose level at screening that deviates from the reference range established by the central laboratory.\n20. Subject is taking a concomitant medication that is a P-glycoprotein (P-gp) inhibitor.\n21. Subject is taking warfarin for a pre-existing condition.","6 Years","12 Years",{"count":85,"type":20},54,[57],"The goal of this clinical trial is to learn how rifaximin 200 mg is processed in the body (pharmacokinetics) in children 6 to 11 years old with acute diarrhea that may be caused by bacteria. It will also learn about the safety and effectiveness of rifaximin when given with oral rehydration therapy (ORT) compared with ORT alone. The main questions it aims to answer are:\n\nHow does rifaximin 200 mg move through and leave the body in children with acute diarrhea?\n\nIs rifaximin safe for children in this age group?\n\nDoes rifaximin plus ORT help resolve diarrhea faster than ORT alone?\n\nResearchers will compare rifaximin plus ORT to ORT alone to see if adding rifaximin improves outcomes.\n\nParticipants will:\n\nTake one rifaximin 200 mg tablet + ORT three times a day for 3 days or receive ORT alone\n\nReceive oral rehydration therapy according to the investigator's standard of care\n\nAttend up to 4 clinic visits over 5 days and receive 4 follow-up phone calls\n\nProvide blood samples on Day 1 and Day 3 for pharmacokinetic testing (rifaximin group only)\n\nProvide stool samples to identify bacterial pathogens\n\nKeep a diary of stool frequency and consistency to help determine when diarrhea resolves\n\nBe monitored for side effects, vital signs, and laboratory changes",[89,90,91],"Diarrhea","Gastroenteritis","Bacterial Infection",[93,94,95,96,97,98,99,100,101,102,103],"pediatric","children","rifaximin","xifaxan","Oral Rehydration Therapy (ORT)","acute diarrhea","bacterial diarrhea","gastroenteritis","open-label","randomized","ages 6-11","2026-03-17",{"date":106,"type":36},"2026-03-18",{"date":108,"type":36},"2026-02-11",{"date":110,"type":20},"2027-07-31",{"name":42,"class":43},5,{"id":114,"slug":115,"hasResults":11,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":4,"eligibilityCriteria":119,"healthyVolunteers":120,"sex":16,"minAge":121,"maxAge":122,"enrollmentInfo":123,"targetDuration":4,"studyType":21,"phases":125,"briefSummary":127,"conditions":128,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":140},"100607341","a-prospective-controlled-study-to-evaluate-the-safety-and-effectiveness-of-thermage-flx-radiofrequency-treatment-100607341","NCT07187297","A Prospective Controlled Study to Evaluate the Safety and Effectiveness of Thermage® FLX Radiofrequency Treatment","A Prospective Controlled Study to Evaluate the Safety and Effectiveness of Thermage® FLX Radiofrequency Treatment to Improve Lines and Wrinkles and to Lift and Tighten Lax Tissue in the Neck, Abdomen, Upper Arms, and Face","Inclusion Criteria:\n\n* Be an adult female or male, ≥30 - ≤60 years of age.\n\nHave mild-to-moderate skin laxity of the neck, abdomen, upper arms, and\u002For face, and\u002For mild-to-moderate lines and\u002For wrinkles of the neck and\u002For face assessed as follows:\n\nNeck:\n\nMild-to-moderate neck skin laxity as defined by a score of 1 to 6 on the 10-point Facial Laxity Rating Scale (scored 0-9)\n\nMild-to-moderate neck wrinkles as defined by a score of 1 to 6 on the 10-point Fitzpatrick Wrinkle Scale (scored 0-9)\n\nAbdomen:\n\nMild-to-moderate abdomen skin laxity as defined by a score of 1 or 2 on a 4-point Abdominal Laxity Scale (scored 0-3)\n\nUpper arms:\n\nMild to moderate upper arms skin laxity as defined by grade 2 or 3 on the 5-grade IBSA Inner Upper Arm Laxity Scale\n\nFace:\n\nMild-to-moderate facial skin laxity as defined by a score of 1 to 6 on the 10-point Facial Laxity Rating Scale (scored 0-9)\n\nMild-to-moderate facial wrinkles as defined by a score of 1 to 6 on the 10-point Fitzpatrick Wrinkle Scale (scored 0-9)\n\nFemales of childbearing potential must have a negative urine pregnancy test. Females who have experienced menarche and who are not postmenopausal (either confirmed via FSH testing or who have not menstruated for 2 years or more without an alternative medical cause) or surgically sterile will be considered of childbearing potential.\n\nFemales of childbearing potential must agree to use an acceptable method of birth control for the duration of the study. Acceptable methods of birth control are oral and other systemic contraceptives, condoms only, intrauterine device, double-barrier methods, bilateral tubal ligation, partner vasectomy, and abstinence.\n\nHave no clinically abnormal findings based on the medical history as determined by the study investigator.\n\nBe able to follow the study instructions, be available on the specific required study visit days, and be willing to complete all study visit procedures and assessments.\n\nUnderstand the research nature of this study and sign an informed consent document prior to the performance of any study-specific procedure or assessment.\n\nAgree to not undergo excluded procedures (i.e., energy-based device treatments, injectables, or plastic surgery) on the study treatment areas for the duration of study.\n\nParticipant has a body mass index (BMI) ≤30.\n\nExclusion Criteria:\n\n* Participant is pregnant or breast feeding or trying to become pregnant for 3 months prior to the screening visit or during the study.\n\nParticipant has given birth within 3 months prior to the screening visit.\n\nParticipant has an anticipated need for procedures, surgery, overnight hospitalization, or other events that would prevent the participant from making the required visits during the study.\n\nParticipant has a pacemaker, internal defibrillator, or other implanted electronic device.\n\nParticipant has an implant in the target treatment zone(s).\n\nParticipant has had radiation therapy in the target treatment zone(s).\n\nParticipant has had 1 or more prior cosmetic procedures in the target treatment zone(s) including:\n\nThermage or any energy-based device procedure, derm abrasion, or chemical peel on any treatment area within 6 months prior to the screening visit.\n\nShort-acting neurotoxins within 6 months prior to the screening visit.\n\nLong-acting neurotoxins within 9 months prior to the screening visit.\n\nHyaluronic acid filler ≤1 year prior to the screening visit.\n\nSemi-permanent or permanent fillers at any time prior to the screening visit.\n\nPlastic surgery within 1 year prior to the screening visit.",true,"30 Years","60 Years",{"count":124,"type":20},164,[126],"NA","A prospective, 180-day, randomized, multicenter, independent blinded evaluators, controlled study of treatment with the Thermage FLX System",[129,130,131],"Wrinkle","Lax Skin","Lines Skin","2025-12-15",{"date":134,"type":36},"2025-12-17",{"date":136,"type":36},"2025-10-31",{"date":138,"type":20},"2027-03",{"name":42,"class":43},1,{"id":142,"slug":143,"hasResults":11,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":4,"eligibilityCriteria":147,"healthyVolunteers":11,"sex":16,"minAge":148,"maxAge":149,"enrollmentInfo":150,"targetDuration":4,"studyType":21,"phases":152,"briefSummary":153,"conditions":154,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":164},"100386641","phase-4-study-to-evaluate-the-safety-efficacy-and-pharmacokinetics-of-budesonide-extended-release-tablets-in-pediatric-subjects-aged-5-to-17-years-with-active-mild-to-moderate-ulcerative-colitis-100386641","NCT04314375","Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Extended-release Tablets in Pediatric Subjects Aged 5 to 17 Years With Active, Mild to Moderate Ulcerative Colitis","A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Extended-release Tablets n Pediatric Subjects Aged 5 to 17 Years With Active, Mild to Moderate Ulcerative Colitis","Inclusion Criteria:\n\n* Established diagnosis of UC is based on:\n\n  * Clinical history\n  * Characteristic endoscopic findings\n  * Histopathology results from biopsies\n* Age 5 to 17 years, inclusive, at Screening. Subjects should weigh greater than 13.6 kg at Baseline.\n* Active UC of mild or moderate severity, defined as a total Mayo score between 4 and 10, inclusive, with rectal bleeding subscore of ≥ 1, stool frequency subscore of ≥1 and an endoscopy subscore of ≥ 1.\n* If on a background oral or rectal 5-ASA, the dose and formulation have remained unchanged for at least 6 weeks prior to Visit 2 (randomization), Baseline and the subject is willing to remain on the same formulation and dose for the duration of the study.\n\nExclusion Criteria:\n\n1. Current or prior diagnosis of Crohn's disease or indeterminate colitis.\n2. Limited distal proctitis (disease involving only the first 15 centimeters or less proximal to the anal verge.\n3. Severe UC, defined as total Mayo score \\>10.\n4. Not currently in an active phase or flare, defined as a total Mayo score \\\u003C4, or Mayo score between 4 and 10, but Mayo subscore of 0 for rectal bleeding, stool frequency or endoscopy.\n5. Infectious colitis (based on positive microbiologic tests at Screening) or any recent history of infectious colitis (within 30 days prior to Screening).\n6. Prior gastrointestinal surgery, except appendectomy or hernia (e.g., inguinal, umbilical).\n\n   NOTE: Prior cholecystectomy is not exclusionary if more than 1 year prior to Screening.\n7. Evidence or history of toxic megacolon or bowel resection.","5 Years","17 Years",{"count":151,"type":20},70,[57],"This is a randomized, double-blind, placebo-controlled, multicenter, study to evaluate the efficacy, safety, and pharmacokinetics (PK) of budesonide extended-release tablets for the induction of remission in pediatric subjects, with active, mild to moderate ulcerative colitis (UC). Subjects will be permitted to continue taking background oral or rectal 5-aminosalicylate (5-ASA) products.",[155],"Ulcerative Colitis","2025-09-14",{"date":158,"type":36},"2025-09-16",{"date":160,"type":36},"2023-09-29",{"date":162,"type":20},"2027-06",{"name":42,"class":43},4,{"id":166,"slug":167,"hasResults":11,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":4,"eligibilityCriteria":171,"healthyVolunteers":11,"sex":16,"minAge":148,"maxAge":149,"enrollmentInfo":172,"targetDuration":4,"studyType":21,"phases":173,"briefSummary":174,"conditions":175,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":179,"completionDateStruct":180,"leadSponsor":182,"locationsCount":4},"100514308","phase-4-dose-ranging-study-to-evaluate-the-safety-efficacy-and-pharmacokinetics-of-budesonide-rectal-foam-in-pediatric-patients-aged-5-to-17-years-with-active-mild-to-moderate-distal-ulcerative-colitis-100514308","NCT05976802","Dose Ranging Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Rectal Foam in Pediatric Patients Aged 5 to 17 Years With Active, Mild to Moderate Distal Ulcerative Colitis","A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose Ranging Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Rectal Foam BID for 2 Weeks, Followed by QD for 4 Weeks, in Pediatric Patients Aged 5 to 17 Years With Active, Mild to Moderate Distal Ulcerative Colitis","Inclusion Criteria:\n\n1. Male and Female (non-pregnant and non-lactating) 5 to ≤17 years of age at Screening.\n2. Established diagnosis of UC, based on clinical history, characteristic endoscopic findings, and histopathology results from biopsies.\n3. Disease limited to the distal colon and rectum, (disease involving only the first 15 centimeters or less proximal to the anal verge).\n4. Active, distal UC of mild or moderate severity, defined as a Modified Mayo Clinic Score (mMCS) between 4 and 8, inclusive, that includes an endoscopy subscore ≥ 2 and a rectal bleeding subscore ≥ 1.\n5. If on a background oral 5-ASA, the dose and formulation have remained unchanged for at least 6 weeks prior to Visit 2 (Run-In) and the subject is willing to remain on the same dosage form and regimen for the duration of the study.\n\nExclusion Criteria:\n\n1. Current or prior diagnosis of Crohn's disease or indeterminate colitis.\n2. Ulcerative colitis involving the proximal colon - i.e, the sigmoid, left, transverse, and\u002For ascending colon and cecum;\n3. Severe UC, defined as an mMCS \\> 8.\n4. Infectious colitis (based on positive microbiologic tests at Screening) or any recent history of infectious colitis (within 30 days of Screening).\n5. Prior gastrointestinal surgery, except appendectomy or hernia (e.g., inguinal, umbilical).\n\n   NOTE: Prior cholecystectomy is not exclusionary if more than 1 year prior to Screening.\n6. Evidence or history of toxic megacolon or bowel resection.\n7. Active proctologic pathology such as hemorrhoids, fistulas and fissures or other historical anatomic problems which would impair rectal administration (e.g., cloaca, imperforate anus history)",{"count":55,"type":20},[57],"The primary objective of this study is to evaluate the efficacy (as measured by induction of remission) of two dose levels (low and high) per age group (5 to \\\u003C12 and 12 to ≤17 years) of budesonide rectal foam as compared to an equivalent volume of rectally administered placebo foam over the same dosing schedule, in pediatric subjects with active, mild to moderate distal ulcerative colitis (UC).",[155],"2025-09-12",{"date":178,"type":36},"2025-09-18",{"date":162,"type":20},{"date":181,"type":20},"2030-01",{"name":42,"class":43},{"id":184,"slug":185,"hasResults":11,"nctId":186,"briefTitle":187,"officialTitle":188,"acronym":4,"eligibilityCriteria":189,"healthyVolunteers":11,"sex":16,"minAge":190,"maxAge":149,"enrollmentInfo":191,"targetDuration":4,"studyType":21,"phases":193,"briefSummary":194,"conditions":195,"keywords":197,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":200,"lastUpdatePostDateStruct":201,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":4},"100219113","phase-4-efficacy-and-safety-of-bupropion-hydrobromide-in-adolescents-and-children-with-major-depressive-disorder-100219113","NCT02129751","Efficacy and Safety of Bupropion Hydrobromide in Adolescents and Children With Major Depressive Disorder","A Double-Blind, Placebo-Controlled, Multicenter Study of Efficacy and Safety of Bupropion Hydrobromide in Adolescents and Children With Major Depressive Disorder","Inclusion Criteria:\n\n* Male or female outpatients aged ≥7 to \\\u003C18 years (at Screening Visit 1).\n* Provide assent (subject) and written informed consent (parent\u002Flegal representative) and Health Insurance Portability and Accountability Act (HIPAA) for study participation (at Screening Visit 1).\n* Meet diagnostic criteria for MDD as defined in the DSM IV-TR5 at Screening Visits 1 and 1a (K-SADS-PL; see Appendix 17.2).\n* Current depressive episode of at least 4 weeks' duration as noted in the subject's history (Screening Visit 1).\n* Total CDRS-R raw score ≥45 at both the Screening and Baseline Visits (Visits 1 and 2) (see Appendix 17.3).\n* CGI-S score of ≥4 at the Baseline Visit (Visit 2) (see Appendix 17.4).\n\nExclusion Criteria:\n\n* are unable to swallow medications without difficulty\n* have known hypersensitivity to bupropion hydrobromide\n* are pregnant or planning to get pregnant or are lactating\n* Women of childbearing age unable to use at least one method of effective contraception for the duration of the study\n* Previous history of attempted suicide\n* are unable to understand and communicate effectively with parent, Investigator, and study coordinator\n* are at immediate risk of requiring hospitalization, in the Investigator's opinion\n* have current seizure disorder or history of seizures or head trauma\n* have history or presence of clinically significant medical conditions or clinically important laboratory abnormalities\n* have ECG or physical examination abnormality at screening\n* have body weight less than the 3rd percentile or greater than the 97th percentile for age.","7 Years",{"count":192,"type":20},246,[57],"Double-Blind, Placebo-Controlled, Multicenter Study of Efficacy and Safety",[196],"Major Depressive Disorder",[198,199],"able to swallow medications without difficulty","bupropion hydrobromide","2025-09-11",{"date":202,"type":36},"2025-09-17",{"date":204,"type":20},"2026-06",{"date":206,"type":20},"2029-12",{"name":42,"class":43},{"id":209,"slug":210,"hasResults":11,"nctId":211,"briefTitle":212,"officialTitle":213,"acronym":4,"eligibilityCriteria":214,"healthyVolunteers":11,"sex":16,"minAge":82,"maxAge":149,"enrollmentInfo":215,"targetDuration":4,"studyType":21,"phases":217,"briefSummary":218,"conditions":219,"keywords":221,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":223,"lastUpdatePostDateStruct":224,"startDateStruct":226,"completionDateStruct":228,"leadSponsor":229,"locationsCount":230},"100361562","phase-4-a-safety-and-pharmacokinetics-study-of-idp-122-lotion-in-pediatric-participants-with-plaque-psoriasis-100361562","NCT03987763","A Safety and Pharmacokinetics Study of IDP-122 Lotion in Pediatric Participants With Plaque Psoriasis","A Phase 4, Open-Label, Multicenter Study Evaluating the Absorption and Systemic Pharmacokinetics and HPA Axis Suppression Potential of Topically Applied IDP-122 Lotion in Pediatric Subjects With Moderate to Severe Plaque Psoriasis","Inclusion Criteria:\n\n* Is 6 to 16 years 11 months of age at time of informed consent\u002Fassent obtained.\n* Verbal and written informed consent\u002Fassent obtained from the participant and\u002For parent or legal guardian.\n* Has a clinical diagnosis of psoriasis at Screening and Baseline with an Investigator's Global Assessment (IGA) score of 3 or 4. The face, scalp, axillae, and intertriginous areas are to be excluded in this assessment, if psoriasis is present.\n* Has an area of plaque psoriasis appropriate for topical treatment that involves a BSA of at least 10% at Screening and Baseline. The face, scalp, axillae, and intertriginous areas are to be excluded in this calculation.\n* Is willing and able to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural and artificial) for the duration of the study.\n* Is in good general adrenal health, as determined by a 30-minute postcosyntropin stimulation serum cortisol level that is \\>18 μg\u002FdL at the Screening visit.\n* Females of childbearing potential and females who are pre-menses (9 years and older) must be willing to practice effective contraception for the duration of the study.\n\nExclusion Criteria:\n\n* Has a history of adrenal disease.\n* Presents with any concurrent skin condition that could interfere with the evaluation of the treatment areas, as determined by the Investigator.\n* Is pregnant, nursing an infant, or planning a pregnancy during the study period.\n* Has received treatment with any investigational drug or device within 60 days or 5 drug half-lives (whichever is longer) prior to baseline or is concurrently participating in another clinical study with an investigational drug or device.\n* Received treatment with a topical antipsoriatic drug product other than corticosteroids within 14 days prior to the Baseline visit and\u002For treatment containing corticosteroids within 28 days prior to the screening HPA axis stimulation test.\n* Has a history of hypersensitivity or allergic reaction to any of the study drug constituents.\n* Is considered by the Investigator, for any other reason, to be an unsuitable candidate for the study.",{"count":216,"type":20},45,[57],"This study is to evaluate the safety, the systemic exposure of halobetasol propionate (HP), and the hypothalamic-pituitary-adrenal (HPA) axis suppression potential for topically applied IDP-122 lotion in pediatric participants with moderate to severe plaque psoriasis.",[220],"Psoriasis",[222],"Plaque psoriasis","2025-08-26",{"date":225,"type":36},"2025-08-27",{"date":227,"type":36},"2019-10-22",{"date":204,"type":20},{"name":42,"class":43},9,""]