protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
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NCT05130762 | 6.4 | Device Labeling | 6.4 Device Labeling This study will utilize marketed product. As such, no special labelling is required. However, to ensure that the BD PureHubTM disinfecting cap will be used at the study sites only on behalf of the study, the device packaging will be labeled as "For clinical trial use only". | [] |
NCT05130762 | 6.5 | Treatment Allocation and Measures to Minimize Bias | 6.5 Treatment Allocation and Measures to Minimize Bias This is a post-market clinical follow up study in which the BD PureHubTM disinfecting cap is used as intended. The choice of using the cap is left to the discretion of the clinician. | [] |
NCT05130762 | 7 | STUDY PROCEDURES AND ASSESSMENTS | 7 STUDY PROCEDURES AND ASSESSMENTS - x Study activities and their timing are summarized in the Schedule of Activities (Table 1) - x Adherence to the study design requirements, is essential and required for study conduct. - x All screening evaluations must be completed and reviewed to confirm that potential participants... | [] |
NCT05130762 | 7.1 | Study duration | 7.1 Study duration The study participation per participant will last 45 days at maximum, the overall conduct of the study is expected to last approximately 14-15 months from first participant enrolled up to last participant having last visit, which is projected for ~ Q2 2023. The anticipated enrollment period is 13 mon... | [] |
NCT05130762 | 7.2 | Screening and Enrollment | 7.2 Screening and Enrollment After screening against inclusion/exclusion criteria, potential participants will be provided with detailed information about the study. For details on the Informed Consent process, please refer to section 14.2. A participant will be considered enrolled once informed consent (or assent as a... | [] |
NCT05130762 | 7.3 | Medical History / Baseline Assessments | 7.3 Medical History / Baseline Assessments Participant baseline and demographic information will be documented, including, but not limited to age, sex assigned at birth, primary diagnosis, and medical history. Information on the participants vascular access device, including but not limited to: - x Type of VADs to be a... | [] |
NCT05130762 | 7.4 | Device Use | 7.4 Device Use Each study participant will have a BD PureHub™ Disinfecting Cap attached to each eligible needle-free connector by a clinician. "Eligible" needle-free connector will be defined as a swabbable needle-free connector not already in use and is reasonably able to be accessed by a clinician. Clinicians should ... | [] |
NCT05130762 | 7.5 | Efficacy (Performance) Assessment | 7.5 Efficacy (Performance) Assessment Clinicians will be requested to document the following with each use of the BD PureHub™ Disinfecting Cap: - x Attachment success: The clinician will document if able to successfully attach the BD PureHub™ Disinfecting Cap to each of the applicable needle-free connectors securely. (... | [] |
NCT05130762 | 7.6 | Safety Assessments | 7.6 Safety Assessments Device-related AEs and device deficiencies will be captured as they occur until the participant concluded his/her participation to the study. Details about AEs are provided in Section 9. | [] |
NCT05130762 | 7.7 | Informational Assessments | 7.7 Informational Assessments The following data may also be collected for informational purposes only: - x Participant in-hospital location: Main department/ward, date of hospitalization, if applicable: any participant transfer in the hospital provided participant is still followed up by the clinical investigation tea... | [] |
NCT05130762 | 8 | PARTICIPANT DISCONTINUATION/WITHDRAWAL | 8 PARTICIPANT DISCONTINUATION/WITHDRAWAL | [] |
NCT05130762 | 8.1 | Discontinuation/Withdrawal | 8.1 Discontinuation/Withdrawal - x A participant may withdraw from the study at any time at his/her own request or may be withdrawn at any time at the discretion of the investigator or sponsor for safety, behavioral, compliance, or administrative reasons. This is expected to be uncommon. - x At the time of discontinuin... | [] |
NCT05130762 | 8.2 | Lost to Follow-Up | 8.2 Lost to Follow-Up Not applicable; these participants will be in the department/hospital for the duration of the study. | [] |
NCT05130762 | 9 | ADVERSE EVENTS AND DEVICE DEFICIENCIES | 9 ADVERSE EVENTS AND DEVICE DEFICIENCIES | [] |
NCT05130762 | 9.1 | Definitions of Events | 9.1 Definitions of Events | [] |
NCT05130762 | 9.1.1 | Adverse Events (AEs) | 9.1.1 Adverse Events (AEs) An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in participants, users or other persons, whether or not related to study device or procedure and whether anticipated or unanticipated [ISO1415... | [] |
NCT05130762 | 9.1.2 | Serious Adverse Events (SAEs) | 9.1.2 Serious Adverse Events (SAEs) A serious adverse event is defined by ISO14155:2020 as an adverse event that led to: - a. death, - b. serious deterioration in the health of the participant, users, or other persons as defined by one or more of the following: - a. a life-threatening illness or injury, or - b. a perma... | [] |
NCT05130762 | 9.1.3 | Adverse Device Effect (ADE) / Serious Adverse Device Effect (SADE) | 9.1.3 Adverse Device Effect (ADE) / Serious Adverse Device Effect (SADE) An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device. This definition includes any event resulting from insufficiencies or inadequacies in the instructions for us... | [] |
NCT05130762 | 9.1.4 | Unanticipated (Serious) Adverse Device Effect (UADE/USADE) | 9.1.4 Unanticipated (Serious) Adverse Device Effect (UADE/USADE) An unanticipated (serious) adverse device effect (UADE/USADE) is any (serious) adverse device effect on health or safety or any life-threatening problem or death caused by, or associated with, a study device, which by its nature, incidence, severity, or o... | [] |
NCT05130762 | 9.2 | Severity of Adverse Events | 9.2 Severity of Adverse Events Each AE shall be assessed for its severity, or the intensity of an event, experienced by the participant according to the criteria below. | Severity Rating | Description | |-----------------|--------------------------------------------------------------------------------------------------... | [] |
NCT05130762 | 9.3 | Relationship of Adverse Event to Device(s)/Procedure | 9.3 Relationship of Adverse Event to Device(s)/Procedure Each AE will be assessed for its relationship to the study device or procedure according to the following guidelines. - A. Assess each AE for its relationship to the device, that is, AEs directly attributable to the study device (BD PureHub™ Disinfecting Cap) use... | [] |
NCT05130762 | 9.4 | Reporting of Events | 9.4 Reporting of Events For all adverse events, all sections of the appropriate electronic Case Report Form (eCRF) must be completed. - x All SAEs, SADEs, and/or UADEs/USADEs must be reported to the Sponsor via the eCRF without unjustified delay and within three (3) working days of the site/investigator becoming aware ... | [] |
NCT05130762 | 9.5 | Safety Committees | 9.5 Safety Committees A safety committee will not be used for this study. | [] |
NCT05130762 | 9.6 | Device Deficiencies | 9.6 Device Deficiencies The Investigator will record a device deficiency if a device used in the study, which appeared to be inadequate with respect to its identity, quality, durability, reliability, usability, safety or performance, whether due to mechanical failure, malfunction, or defect. Device deficiencies also in... | [] |
NCT05130762 | 9.7 | Serious Health Threat | 9.7 Serious Health Threat During the course of the study, device deficiencies or adverse events will be assessed if they constitute a serious health threat. The serious health threat is a signal from any adverse event or device deficiency that indicates an imminent risk of death or a serious deterioration in the health... | [] |
NCT05130762 | 10 | STATISTICAL METHODS | 10 STATISTICAL METHODS The statistical analysis plan will be finalized prior to the database lock and will include a more technical and detailed description of the statistical analyses described in the following sections. This section includes a summary of the planned statistical analyses of the most important endpoint... | [] |
NCT05130762 | 10.1 | Overview of Study Design | 10.1 Overview of Study Design This is a multi-center, single-arm, prospective study to assess the overall safety and performance of the BD PureHub™ Disinfecting Cap. | [] |
NCT05130762 | 10.2 | Sample Size Considerations | 10.2 Sample Size Considerations Assuming the primary endpoints of successful insertion rate and successful removal rate are each 90%, a sample size of 150 participants with only 1 insertion/removal observed per participant would result in a 4.8% precision for each point estimate (i.e. the 95% confidence interval (CI) i... | [] |
NCT05130762 | 10.3 | Analysis Population | 10.3 Analysis Population The following populations are defined: | Population | Description | |------------|----------------------------------------------------------------------------------------| | Enrolled | All participants who sign the ICF | | Evaluable | All enrolled participants who have at least 1 BD PureHub™Dis... | [] |
NCT05130762 | 10.4 | Primary Performance Endpoints | 10.4 Primary Performance Endpoints The attachment (removal) success rate will be calculated by dividing the number of successful attachment (removal) by the total number of attachments (removals); 95% CI will be calculated using a score method. | [] |
NCT05130762 | 10.5 | Primary Safety Endpoint | 10.5 Primary Safety Endpoint The rate of device-related adverse events will be calculated as the number of participants with adverse events related to device divided by the total number of participants; 95% CI will be calculated using a score method. | [] |
NCT05130762 | 10.6 | Informational Endpoint(s) | 10.6 Informational Endpoint(s) Descriptive statistics for the informational endpoints defined in Section 3 will be provided. Summary statistics for categorical variables will include frequency counts and percentages and for continuous variables will include mean, standard deviation, minimum, median, and maximum. | [] |
NCT05130762 | 10.7 | Other Analyses | 10.7 Other Analyses Not applicable. | [] |
NCT05130762 | 10.8 | Interim Analysis | 10.8 Interim Analysis No interim analysis is planned for this study. | [] |
NCT05130762 | 11 | DATA COLLECTION AND RECORD MAINTENANCE | 11 DATA COLLECTION AND RECORD MAINTENANCE | [] |
NCT05130762 | 11.1 | Electronic Case Report Forms | 11.1 Electronic Case Report Forms The Investigator is responsible for ensuring the completeness and accuracy of all study documentation. All required clinical data will be collected/documented in sponsor-provided electronic Case Report Forms (eCRFs). Applicable national and local regulations are followed on the handlin... | [] |
NCT05130762 | 11.2 | Source Documentation | 11.2 Source Documentation Original or certified copies of all relevant clinical findings, observations, and other activities throughout the clinical investigation must be recorded and maintained in the medical file of each enrolled participant. | [] |
NCT05130762 | 11.3 | Data Management | 11.3 Data Management Data management is the responsibility of the Sponsor or their designee. Data from completed eCRFs will be managed in a secured, controlled database. A Data Management Plan (DMP) will be developed that outlines the procedures used for recording, data tracking, data review, database cleaning, issuing... | [] |
NCT05130762 | 11.4 | Record Retention | 11.4 Record Retention The Investigator shall retain all study records for a minimum of ten (10) years after the study has ended. Study records may be stored longer if required by national law or other local rules. The data for some of these records may be available in computerized form but the final responsibility for ... | [] |
NCT05130762 | 11.5 | Device accountability | 11.5 Device accountability If a study site is provided with PureHub™ Disinfecting Caps by the Sponsor, device accountability between Sponsor and the site will be performed (Number of devices shipped, number of devices used at trial site, number of devices shipped back/discarded at end of study). In this case, Principal... | [] |
NCT05130762 | 12 | QUALITY CONTROL AND ASSURANCE | 12 QUALITY CONTROL AND ASSURANCE | [] |
NCT05130762 | 12.1 | Control of Study Products | 12.1 Control of Study Products In this post-market study, marketed devices will be used, provided by the Sponsor. No special controls are required in this study. | [] |
NCT05130762 | 12.2 | Monitoring | 12.2 Monitoring The Sponsor will designate trained and qualified personnel to monitor the progress of this clinical study in accordance with established standard operating procedures and the studyspecific Monitoring Plan. Prior to study start, a study initiation visit (SIV) will be conducted to review with the Investig... | [] |
NCT05130762 | 12.3 | Audits and Inspections | 12.3 Audits and Inspections If the study is selected for audit by the Sponsor or if there is an inspection by the appropriate Health Authorities, the Investigator and his team will make themselves available during the visit. The Investigator must agree to the inspection of all study related records and give the auditor... | [] |
NCT05130762 | 12.4 | Protocol Deviations | 12.4 Protocol Deviations A protocol deviation is defined as an event where the Investigator or site personnel did not conduct the study according to the protocol. Except when necessary to protect the life or physical well-being of a participant, protocol deviations are not permitted. The Sponsor and the investigational... | [] |
NCT05130762 | 13 | ADMINISTRATIVE REQUIREMENTS | 13 ADMINISTRATIVE REQUIREMENTS | [] |
NCT05130762 | 13.1 | Investigator and Site Selection | 13.1 Investigator and Site Selection The Investigator must be of good standing as an Investigator and knowledgeable in relevant areas of clinical research to ensure adherence to the requirements of this protocol, including the protection of human participants. Other site personnel must have appropriate research experie... | [] |
NCT05130762 | 13.2 | Training | 13.2 Training Each Investigator and appropriate site personnel will be trained on this protocol and study requirements during the SIV and on the study device, if needed. All training will be documented and filed at the investigational site and with the Sponsor. | [] |
NCT05130762 | 13.3 | Required Documents | 13.3 Required Documents An Investigator may not screen or enroll participants until authorized to do so by the Sponsor. At a minimum, the following documentation should be received by the Sponsor prior to the commencement of study activities: - x Fully executed Non-disclosure Agreement (NDA) between PI/site and Sponsor... | [] |
NCT05130762 | 13.4 | Insurance | 13.4 Insurance Where required by local regulation, insurance coverage will be provided by BD for study participants. | [] |
NCT05130762 | 13.5 | Publication Policy | 13.5 Publication Policy The sponsor believes that results of applicable clinical studies should be published in peerreviewed literature in a timely, accurate, complete and balanced manner, regardless of study outcomes, whenever possible. As such, at the conclusion of this study, an article may be prepared for publicati... | [] |
NCT05130762 | 13.6 | Study Registration | 13.6 Study Registration While this is a not an Applicable Clinical Trial and does not meet the FDA Amendments Act of 2007 (FDAAA) criteria for clinical study registration, the study will be registered on www.clinicaltrials.gov to ensure transparency. The study will also be registered on additional local registries, if ... | [] |
NCT05130762 | 13.7 | Termination of Study | 13.7 Termination of Study The Sponsor reserves the right to suspend enrollment or terminate the study at any time for any reason. If suspicion of an unacceptable risk, including serious health threat to subjects, arises during the study, the Sponsor may suspend the study while the risk is assessed. The sponsor shall te... | [] |
NCT05130762 | 14 | ETHICAL AND REGULATORY CONSIDERATIONS | 14 ETHICAL AND REGULATORY CONSIDERATIONS | [] |
NCT05130762 | 14.1 | IRB/EC Approval | 14.1 IRB/EC Approval Investigators or designees must submit the study protocol, Informed Consent Forms (if applicable), and all other locally required documentation to an appropriate IRB/EC and obtain study-specific written approval (favorable opinion) before being allowed to participate in the study. Before commenceme... | [] |
NCT05130762 | 14.2 | Informed Consent and Confidentiality | 14.2 Informed Consent and Confidentiality Prior to any study procedure, the Investigator (or designee) must explain to each participant in layman's terms, the nature of the study, its purpose, expected duration, and the risks and benefits of study participation. For participants under the age of 18, participants' paren... | [] |
NCT05130762 | 14.2.1 | Confidentiality | 14.2.1 Confidentiality Participant confidentiality must be strictly held in trust by the Investigator, study staff, and the Sponsor. Participant confidentiality and anonymity will be maintained by removal of identifiers from any data, documentation, or clinical samples submitted to the Sponsor. Any data collected meeti... | [] |
NCT05130762 | 14.3 | Regulatory Status | 14.3 Regulatory Status The study device is CE marked and will be studied in a post-market fashion in Europe. | [] |
NCT05130762 | 14.4 | Statement of Compliance | 14.4 Statement of Compliance This clinical investigation will be conducted in compliance with the protocol and following regulatory requirements: - x ISO14155:2020 (Good Clinical Practice); - x EU MDR (Council Regulation 2017/745 of 5 April 2017); - x Ethical principles of the Declaration of Helsinki, in its current re... | [] |
NCT05130762 | 15 | REFERENCES | 15 REFERENCES Gahlot, R., Nigam, C., Kumar, V., Yadav, G., & Anupurba, S. (2014). Catheter-related bloodstream infections. International Journal of Critical Illness and Injury Science, 4(2), 162–167. https://doi.org/10.4103/2229-5151.134184 Hollenbeak, C. S. (2011). The cost of catheter-related bloodstream infections: ... | [] |
NCT05136417 | 1.0 | PURPOSE OF THE INVESTIGATION | 1.0 PURPOSE OF THE INVESTIGATION The aim of this multi-center study will be to assess the feasibility and safety of left atrial appendage (LAA) occlusion with the WATCHMAN FLX™ device using a standardized intra-procedural intracardiac echocardiography (ICE) protocol under moderate sedation for procedural guidance. By e... | [] |
NCT05136417 | 2.0 | CLINICAL PROTOCOL | 2.0 CLINICAL PROTOCOL The study will be a prospective, non-randomized multicenter registry of 110 patients undergoing LAA closure with the WATCHMAN FLX utilizing an intra-procedural ICE probe under moderate sedation. The primary feasibility endpoint will be ability to successfully implant the WATCHMAN FLX device. Impla... | [] |
NCT05136417 | 2.1 | SUBJECT SELECTION | 2.1 SUBJECT SELECTION A total of 3 sites will enroll up to 110 consecutive patients, allowing room for 10 withdrawals to ensure data is collected on 100. | [] |
NCT05136417 | 2.2 | INCLUSION CRITERIA | 2.2 INCLUSION CRITERIA Determination for participation in the study is based on institutional standard of care practice for assessment of WATCHMAN FLX eligibility. Patients that are being considered for LAA Closure with WATCHMAN FLX device implant based on a history of non-valvular atrial fibrillation who are at increa... | [
"Key inclusion criteria:"
] |
NCT05136417 | 2.3 | EXCLUSION CRITERIA | 2.3 EXCLUSION CRITERIA No specific exclusion criteria will be implemented based on age, weight, body habitus, renal insufficiency, LAA anatomy, or the presence of sleep apnea or chronic lung disease. However, Patients will be excluded from the study if the treating physician(s) feel that general anesthesia is necessary... | [
"Key exclusion criteria:"
] |
NCT05136417 | 2.4 | STUDY PROCEDURE | 2.4 STUDY PROCEDURE Pre-Procedure: Informed consent should be obtained from the patient prior to the start of the procedure or within 48 hours post-WATCHMAN FLX procedure if ICE protocol is utilized. Preprocedural planning will be according to standard WATCHMAN FLX and local institution protocols. The use of cardiac CT... | [] |
NCT05136417 | 2.5 | Study endpoints | 2.5 Study endpoints The primary feasibility endpoint will be ability to successfully implant the WATCHMAN FLX device. Implant success is defined as confirmation of the device-specified release criteria on ICE (ICE-PASS), successful device release, and adequate seal (defined as a residual leak <5 mm) assessed by TEE or ... | [] |
NCT05136417 | 2.5.1 | Sample size determination | 2.5.1 Sample size determination The registry will enroll up to 110 patients, allowing room for 10 withdrawals to ensure data is collected on 100. | [] |
NCT05136417 | 2.5.2 | Outcome data and data analysis | 2.5.2 Outcome data and data analysis Mayo Clinic Cardiovascular Imaging Core Laboratory will do data analysis. | [] |
NCT05136417 | 2.5.3 | Data and Safety Monitoring Committee | 2.5.3 Data and Safety Monitoring Committee There will be no data and safety monitoring committee for this registry as the WATCHMAN FLX procedure is considered standard of care with either TEE or ICE at the participating institutions. Each site is expected to monitor appropriateness and outcomes of implant. | [] |
NCT05136417 | 3.0 | RISK ANALYSIS | 3.0 RISK ANALYSIS Major procedural complications will be reported through the data collection form. However, since this is an observational registry that only collects clinical and imaging data from standardof-care routine procedures, adverse events will not be separately reported to the IRB. | [] |
NCT05136417 | 4.0 | IRB INFORMATION | 4.0 IRB INFORMATION Each site is responsible for its own institutional review board. | [] |
NCT05136417 | 5.0 | ADDITIONAL RECORDS AND REPORTS | 5.0 ADDITIONAL RECORDS AND REPORTS | [] |
NCT05136417 | 5.1 | Data handling and record-keeping | 5.1 Data handling and record-keeping Each institution will be responsible for individual data handling and record keeping. A Data collection sheet will be used to record procedure related characteristics and track any complications. The site-specific primary investigator will be responsible for this form's accuracy and... | [] |
NCT05136417 | 5.2 | Record maintenance and retention | 5.2 Record maintenance and retention Originals of all images, WATCHMAN FLX Implant Form, and data collection form will be maintained at each site. A copy of this information should be sent to the study primary investigator. | [] |
NCT05186805 | 1 | Introduction | 1 Introduction | [] |
NCT05186805 | 1.1 | Background Information and Study Rationale | 1.1 Background Information and Study Rationale | [] |
NCT05186805 | 1.1.1 | Background Information | 1.1.1 Background Information Atopic dermatitis (AD) (also called atopic eczema) is an intensely pruritic, chronic, relapsing, inflammatory skin disease [Bieber, 2008]. The characteristic signs and symptoms of AD include sensations of pruritis and burning, xerosis, erythematous papules and plaques, exudation, crusting, ... | [] |
NCT05186805 | 1.1.2 | Study Rationale | 1.1.2 Study Rationale This Phase 2a maximal use study is being conducted as part of a clinical development program to evaluate the safety and systemic exposure of tapinarof cream, 1% for the topical treatment of AD in subjects ages 2 to 17 years. Maximal use trials enroll subjects with the disease under study and who g... | [] |
NCT05186805 | 1.2 | Rationale for Study Design and Dose | 1.2 Rationale for Study Design and Dose The dose of tapinarof in this trial will be the 1% cream administered QD, the same as that studied in the Phase 3 pivotal trials in plaque psoriasis and in the maximal use study in plaque psoriasis. This is also the dose that was selected for the Phase 3 pivotal trials in AD base... | [] |
NCT05186805 | 1.3 | Potential Risks and Benefits | 1.3 Potential Risks and Benefits To assess any potential impact on subject eligibility with regard to safety, the Investigator must refer to the current version of the tapinarof Investigator's Brochure for detailed information regarding warnings, precautions, contraindications, adverse events (AEs), and other significa... | [] |
NCT05186805 | 1.3.2 | Benefit Assessment | 1.3.2 Benefit Assessment Subjects may experience improvements in their AD during the course of the study and may benefit from the additional safety assessments conducted as part of the study (e.g., physical examination, laboratory tests). Subjects in the study will also contribute to the process of developing a novel a... | [] |
NCT05186805 | 1.3.3 | Overall Benefit Risk | 1.3.3 Overall Benefit Risk Taking into account the measures taken to minimize risk to subjects in this study, the potential risks identified in association with tapinarof are justified by the anticipated benefits that may be afforded to subjects with AD. | [] |
NCT05186805 | 2 | Objectives and Endpoints | 2 Objectives and Endpoints The objectives and associated endpoints of the study are as follows: | Objectives | Associated Endpoint | |---------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------... | [] |
NCT05186805 | 3 | Study Design | 3 Study Design | [] |
NCT05186805 | 3.1 | Overall Design | 3.1 Overall Design This is a Phase 2a, multicenter, open-label, safety, tolerability and PK study in pediatric subjects with AD. The study will consist of three phases: Screening (up to 30 days), Treatment (27 days), and Follow-up (approximately 7 days). At Day 1 (Baseline), eligible subjects and/or their caregiver(s) ... | [] |
NCT05186805 | 3.2 | Treatment Groups and Duration | 3.2 Treatment Groups and Duration All subjects will receive tapinarof cream, 1% QD for 27 days, at an appropriate dose in accordance with the size of the affected area. Subjects or their caregivers will be instructed to apply a thin layer to the affected areas. | [] |
NCT05186805 | 3.3 | Definition of Study Completion and Eligibility for Long-Term Extension Study | 3.3 Definition of Study Completion and Eligibility for Long-Term Extension Study In order to complete the study, a subject must complete 4 weeks of assessments. To be considered a "study completer" in terms of treatment period, a subject must complete ≥ 80.0% of the intended doses. The number of intended doses is defin... | [] |
NCT05186805 | 4 | Study Population | 4 Study Population | [] |
NCT05186805 | 4.1 | Type and Number of Subjects | 4.1 Type and Number of Subjects Approximately 36 subjects ages 2 to 17 years old will be enrolled in the study with approximately 12 subjects, and a minimum of 10 subjects, enrolled into each of the three following age cohorts: 2-6 years old, 7-11 years old, 12-17 years old. Subjects across the age range will be enroll... | [] |
NCT05186805 | 4.2 | Inclusion Criteria | 4.2 Inclusion Criteria Each subject must meet all of the following criteria to be eligible to participate in the study: - 1. Male and female subjects ages 2 to 17 years with a clinical diagnosis of AD by Hanifin and Rajka criteria [Hanifin, 1980] (see Appendix 1). - 2. Subjects with AD covering ≥25% of the BSA for subj... | [] |
NCT05186805 | 4.3 | Exclusion Criteria | 4.3 Exclusion Criteria A subject who meets any of the following criteria will be excluded and considered ineligible for participation in the study:
1. Concurrent conditions: - a. Immunocompromised (e.g., lymphoma, acquired immunodeficiency syndrome) or medical history of positive human immunodeficiency virus antibody ... | [
"1. Concurrent conditions:"
] |
NCT05186805 | 4.4 | Lifestyle Restrictions | 4.4 Lifestyle Restrictions Subjects must avoid ultraviolet light, phototherapy, and excessive sun exposure throughout the study. When prolonged exposure cannot be avoided, use of sunscreen products (except on AD lesions) and protective apparel are recommended. | [] |
NCT05186805 | 4.5 | Screening/Baseline Failures | 4.5 Screening/Baseline Failures To determine subject eligibility at Screening and Baseline, a single repeat of tests or procedures may be allowed during the screening period at the discretion of the Investigator; the Medical Monitor should be consulted if needed. Screen failures are defined as subjects who consent to p... | [] |
NCT05186805 | 4.6 | Withdrawal Criteria | 4.6 Withdrawal Criteria A subject may voluntarily discontinue treatment and/or withdraw from participation in this study at any time at his/her own request or may be discontinued from study treatment at any time at the discretion of the Investigator for safety, behavioral, compliance, or administrative reasons. Subject... | [] |
NCT05186805 | 4.6.1 | Reasons for Withdrawal from the Study | 4.6.1 Reasons for Withdrawal from the Study Study drug will be discontinued and the subject will be withdrawn from the study for any of the following reasons: - Subject has an AE that is considered to be related to study drug or procedures AND is severe enough to warrant treatment discontinuation, as determined by the ... | [] |
NCT05186805 | 4.6.2 | Withdrawal Procedures | 4.6.2 Withdrawal Procedures The primary reason for the discontinuation of study drug and/or withdrawal from study must be recorded in the source document and on the case report form (CRF). If a subject is prematurely discontinued from study drug, the Investigator must make every effort to perform an Early Termination V... | [] |
NCT05186805 | 4.7 | Lost to Follow-Up | 4.7 Lost to Follow-Up A subject is considered lost to follow-up if he/she repeatedly fails to return to the study site for scheduled visits and is unable to be contacted by the study site. The following actions must be taken if a subject fails to return to the clinic for a required study visit: - The site must attempt ... | [] |
NCT05186805 | 5 | Study Treatment | 5 Study Treatment | [] |
NCT05186805 | 5.1 | Study Drug | 5.1 Study Drug | [] |
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