protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT03940963 | 3.9.3 | Visit 3: Post Operative Visit, Day 14/Week 2 | 3.9.3 Visit 3: Post Operative Visit, Day 14/Week 2 Visit 3 (Week 2) is a safety visit and the following will be performed. - Obtain relevant vital signs (height / weight) - Post-Operative Care e - Wound Assessment (safety check remove sutures, wound check, etc.) - Pain Assessments (VAS, PROMIS®) B - Concomitant Medicat... | [] |
NCT03940963 | 3.9.4 | Visits 4: Months 1 | 3.9.4 Visits 4: Months 1 The following will be performed at Visits 4: - 1. Obtain relevant vital signs (height / weight) - 2. Wound Assessment - 3. Pain Assessments (VAS, PROMIS®) - ¥ "uo1 i Queionaives (115 - 6. Concomitant Medication review and Daily Pain Medication Diary review (treatments including quantity and cla... | [] |
NCT03940963 | 3.9.5 | Visits 5-7: Months 3, 6, 9| | 3.9.5 Visits 5-7: Months 3, 6, 9| The following will be performed at Visits 5 through 7: 1. Obtain relevant vital signs (height / weight) - 2. Pain Assessments (VAS, PROMIS®) - . Concomutant Medication review and Daily Pain Medication Diary review (treatments including quantity and class of pain medications, review wit... | [] |
NCT03940963 | 3.9.6 | Visit 8: End of Study/Early Termination Visit, Month 12 | 3.9.6 Visit 8: End of Study/Early Termination Visit, Month 12 The following will be performed at Visit 8/End of Study/Early Termination: - Obtain relevant vital signs (height / weight) i i Quesicansives 15 = - 'Wound Assessment - Pain Assessments (VAS, PROMIS®) e - = - 6. Concomitant Medication review and Daily Pain Me... | [] |
NCT03940963 | 3.10 | Subject/Study Discontinuation | 3.10 Subject/Study Discontinuation | [] |
NCT03940963 | 3.10.1 | Screen Failures | 3.10.1 Screen Failures A screen failure is defined as subject from whom informed consent is obtained, but e Inclusion/Exclusion criteria are not met, or - e Subject was unable to be randomized, or - o Subject withdrew consent prior to randomization/surgical intervention. | [] |
NCT03940963 | 3.10.2 | Subject Discontinuation | 3.10.2 Subject Discontinuation Subjects may end their participation in the study at any time for any reason(s). The reason for discontinuation should be documented. Early termination will be defined as any post-randomization study termination prior to completion of the Month 12 assessment. Subjects that terminate early... | [] |
NCT03940963 | 3.10.3 | Termination of the Study | 3.10.3 Termination of the Study Conditions that may warrant termination of the clinical study include, but are not limited to, the following: e Discovery of an unexpected, serious, or unacceptable risk to subjects; or, - e Decision by the Sponsor to suspend or discontinue testing, evaluation, or development of the stud... | [] |
NCT03940963 | 4 | ADVERSE EVENTS | 4. ADVERSE EVENTS | [] |
NCT03940963 | 4.1 | Adverse Event Definitions | 4.1 Adverse Event Definitions An adverse event (AE) is defined as any untoward event (including abnormal lab findings) experienced by a subject (whether or not considered product-related by the Investigator or Sponsor) after the patient consents to participate in the trial. All AEs that occur during or after study prod... | [] |
NCT03940963 | 4.2 | List of Anticipated Adverse Events | 4.2 List of Anticipated Adverse Events Consistent with the subject's informed consent form and the risk analysis section of this protocol, the following adverse events are known and may potentially occur during the subject's participation in this investigation: - e mild incisional redness; - tenderness of surgical area... | [] |
NCT03940963 | 4.3 | Severity of Adverse Events | 4.3 Severity of Adverse Events Adverse events will be graded for severity and noted in the description of the event using the NCI (NIH)-developed Common Terminology Criteria for Adverse Events (NCI\CTCAE), Version 5.0. In addition, any AE associated with subject termination from the study must be reported according to ... | [] |
NCT03940963 | 4.4 | Relationship to Study Product or Control Procedure | 4.4 Relationship to Study Product or Control Procedure The Investigator will assess the relationship of each adverse event to the study product and study procedure. using the criteria outlined in Table 4.4-1. | Relationship | Description | |--------------|----------------------------------------------------------------... | [] |
NCT03940963 | 4.5 | Adverse Event Reporting Procedures | 4.5 Adverse Event Reporting Procedures The Investigator is responsible for recording and reporting all Adverse Events observed or reported during the study, regardless of their relationship to the study product or their clinical significance. Subjects will be instructed to contact the site Investigator at any time if s... | [] |
NCT03940963 | 4.6 | Serious Adverse Events | 4.6 Serious Adverse Events A Serious Adverse Event (SAE) is any untoward medical occurrence that occurs per the following definition: 39 - x Results in death; - x Is immediately life threatening In the opinion of the site Investigator, the participant was at substantial risk of dying at the time of the event, or use or... | [] |
NCT03940963 | 4.6.1 | Reporting Serious Adverse Events | 4.6.1 Reporting Serious Adverse Events All SAEs must be reported immediately to the Sponsor or designee (within 24 hours of awareness)Serious Adverse Event forms should be submitted to: > Ivica Ducic, MD PhD Axogen, Corp. Medical Affairs 13631 Progress Blvd; Suite 400 Alachua, FL 32615 The site Investigator or designee... | [] |
NCT03940963 | 4.7 | Unanticipated Adverse Device Effects (UADE) | 4.7 Unanticipated Adverse Device Effects (UADE) An unanticipated adverse device effect (UADE) is defined as any serious adverse effect on health or safety or any life-threatening problem or death caused by, or associated with, a device, if that effect, problem, or death was not previously identified in nature, severity... | [] |
NCT03940963 | 4.7.1 | Reporting of Unanticipated Adverse Device Effects (UADE) | 4.7.1 Reporting of Unanticipated Adverse Device Effects (UADE) The Investigator should report any unanticipated adverse device effects to the Sponsor and the IRB as soon as possible, but no less than 10 working days after the site Investigator first learns of the UADE. The Sponsor must immediately conduct an evaluation... | [] |
NCT03940963 | 4.8 | Follow-up of Adverse Events | 4.8 Follow-up of Adverse Events All adverse events ongoing at the final study visit will be followed by the site Investigator: - x until the adverse event has resolved; or - x until the subject is lost to follow-up; or - x until the adverse event is stabilized or deemed a permanent disease or condition. "Resolution" of... | [] |
NCT03940963 | 4.9 | Review of Safety Information | 4.9 Review of Safety Information The Sponsor shall promptly review all information relevant to the safety of the study device or otherwise received by the Sponsor from any source, foreign or domestic, including information derived from any clinical or epidemiological investigations, animal investigations, commercial ma... | [] |
NCT03940963 | 5 | STATISTICAL CONSIDERATIONS | 5. STATISTICAL CONSIDERATIONS Descriptive statistical methods will be used to summarize the data from this study. Unless stated otherwise, the term "descriptive statistics" refers to number of events (n), mean, median, standard deviation (SD), standard error, minimum, maximum, and coefficient of variation (CV) for cont... | [] |
NCT03940963 | 5.1 | Data Collection Methods | 5.1 Data Collection Methods The data will be recorded on an approved Case Report Form (CRF). The CRF for this study may be either a paper CRF, or at Axogen's discretion, the data collection methods may be an electronic CRF,. All investigative site source documentation supporting the CRF data, such as laboratory or hosp... | [] |
NCT03940963 | 5.2 | Statistical Analysis Plans | 5.2 Statistical Analysis Plans A statistical analysis plan (SAP) will be created and approved prior to the beginning of subject enrollment. This document will provide a more technical and detailed description of the proposed data analyses and statistical methods. | [] |
NCT03940963 | 5.3 | Hypotheses Tested Test of non-inferiority and superiority of Axoguard® Nerve Cap compared to neurectomy with respect to VAS ivisual aualui scale Iiain score will be conducted using closed testing procedures. - | 5.3 Hypotheses Tested Test of non-inferiority and superiority of Axoguard® Nerve Cap compared to neurectomy with respect to VAS ivisual aualui scale Iiain score will be conducted using closed testing procedures. - | effectsSample Size Estimates5.4total of 101 subiects at ui oA10 sites may be enrolled to control for sit... | [] |
NCT03940963 | 5.5.1 | Intent-To-Treat Population | 5.5.1 Intent-To-Treat Population | [] |
NCT03940963 | 5.5.2 | Safety Population | 5.5.2 Safety Population | [] |
NCT03940963 | 5.5.3 | Per Protocol Population | 5.5.3 Per Protocol Population analysis population for the test of non-inferiority using the difference between repair types. A final analysis is planned after the last subject completes or discontinues the study, and the resulting clinical database has been cleaned, quality checked, and locked. The pilot phase data wil... | [] |
NCT03940963 | 5.7 | General Issues for Statistical Analysis | 5.7 General Issues for Statistical Analysis | [] |
NCT03940963 | 5.7.1 | Multiple Comparisons and Multiplicity | 5.7.1 Multiple Comparisons and Multiplicity All summaries of categorical data will be presented in frequencies and percentages. All summaries of continuous data will be presented by the number of non-missing values, mean, standard deviation, standard error, median, minimum, maximum, and coefficient of variation. Mann-W... | [] |
NCT03940963 | 5.7.2 | Covariates | 5.7.2 Covariates These analyses may be stratified to identify other important factors which may impact nerve recove: | [] |
NCT03940963 | 5.7.3 | Planned Subgroups | 5.7.3 Planned Subgroups | [] |
NCT03940963 | 5.7.4 | Missing Data | 5.7.4 Missing Data Every effort will be made to obtain the required data at each scheduled evaluation from all subjects who have been randomized. In assessing the primary efficacy endpoint. a repeated measures mixed model will be utilized on all observed data. | [] |
NCT03940963 | 5.7.5 | Demographic and Baseline Characteristics | 5.7.5 Demographic and Baseline Characteristics Demographic and baseline characteristics including age, sex, race, type of traumatic injury sustained, nerves that are injured, pain assessments, concomitant treatments, quality of life assessments will be summarized descriptively. | [] |
NCT03940963 | 5.8 | Efficacy Analyses | 5.8 Efficacy Analyses | [] |
NCT03940963 | 5.8.1 | Primary Efficacy Endpoint | 5.8.1 Primary Efficacy Endpoint The primary efficacy endpoint for both the pilot and comparative studies will be the change of VAS score at 3 months compared to baseline for subjects in both the Axoguard® Nerve Cap study arm and the neurectomy control arm. | [] |
NCT03940963 | 5.8.2 | Secondary Efficacy Endpoints | 5.8.2 Secondary Efficacy Endpoints The secondary efficacy endpoints for the comparative study are VAS, PROMIS® and FHSQ scores at months 1, 3, 6,9 and 12 compared to baseline; and quantity and class of pain medication use at months 1,3, 6,9, and 12 months compared to baseline for subjects assigned to the Axoguard® Nerv... | [] |
NCT03940963 | 5.10 | Study Success | 5.10 Study Success Study success is defined as demonstrating the reduction in pain by VAS score with the treatment of Axoguard® Nerve Cap is superior to the reduction in VAS score for neurectomy group In addition, there should be no clinically significant difference of product related adverse events rates following imp... | [] |
NCT03940963 | 6 | STUDY PRODUCT MANAGEMENT | 6. STUDY PRODUCT MANAGEMENT | [] |
NCT03940963 | 6.1 | Packaging and Labeling | 6.1 Packaging and Labeling Commercially available product will be used. | [] |
NCT03940963 | 6.2 | Handling, Storage, and Disposal | 6.2 Handling, Storage, and Disposal Per product specifications as defined in the Instructions for Use (see Appendix C). | [] |
NCT03940963 | 7 | RECORDS MANAGEMENT | 7. RECORDS MANAGEMENT | [] |
NCT03940963 | 7.1 | Data Collection | 7.1 Data Collection During each subject's visit, the Investigator or designee shall document all significant observations. Information from the source documents will be promptly transcribed to either a paper case report form (CRF) document or an electronic data capture system (EDC) via electronic CRFs. Any changes in i... | [] |
NCT03940963 | 7.2 | Source Documents | 7.2 Source Documents Source documents are defined as the result of original observations and activities of a clinical investigation. Source documents will include, but are not limited to, progress notes, electronic data, screening logs, and recorded data from automated instruments. All source documents pertaining to th... | [] |
NCT03940963 | 7.3 | File Management at the Study Site | 7.3 File Management at the Study Site It is the responsibility of the site Investigator to ensure that the site files are adequately and accurately maintained in accordance with Section 8 of the International Conference on Harmonization (ICH) Guideline for Good Clinical Practice (GCP) FDA regulations and ISO 14155:2011... | [] |
NCT03940963 | 7.4 | Records Retention at the Study Site | 7.4 Records Retention at the Study Site Essential documents should be retained until at least 2 years after the last approval of a marketing application or until at least 2 years have elapsed since the formal discontinuation of the clinical development of the investigational product. However, essential documents may be... | [] |
NCT03940963 | 8 | QUALITY CONTROL AND QUALITY ASSURANCES | 8. QUALITY CONTROL AND QUALITY ASSURANCES | [] |
NCT03940963 | 8.1 | Data Management Considerations | 8.1 Data Management Considerations Data analysis will be overseen by the Sponsor's Data Management Team. All data associated with this study will be held to a Data Management Plan. Original study logs will remain secured at the clinical site and a copy will be transmitted to the data manager. Paper copies received by t... | [] |
NCT03940963 | 8.2 | Monitoring | 8.2 Monitoring The Sponsor or their authorized designee will conduct routine monitoring visits to ensure the safe and ethical conduct of the study. This will include routine data monitoring of the study's critical variables that are defined in the data management plan and clinical monitoring plan. As part of a concerte... | [] |
NCT03940963 | 8.3 | Auditing | 8.3 Auditing The Sponsor or Regulatory representatives or authorized designee may conduct audits at the study site(s). Audits will include, but are not limited to, product supply, presence of required documents, the informed consent process, and comparison of case report forms with source documents, logs/forms, trainin... | [] |
NCT03940963 | 9 | ETHICS AND RESPONSIBILITY | 9. ETHICS AND RESPONSIBILITY This study must be conducted in compliance with the protocol, FDA regulations, ICH and GCP Guidelines, ISO 14155:2011 and all other applicable regulatory requirements. The study protocol and the written informed consent form must receive a favorable review and/or approval from the governing... | [] |
NCT03940963 | 10 | CLINICAL STUDY REPORT | 10. CLINICAL STUDY REPORT a final clinical study report will be prepared at the completion of the study. This report will be provided to the collaborative site Investigators. | [] |
NCT03940963 | 11 | CONFIDENTIALITY | 11. CONFIDENTIALITY All information generated in this study must be considered highly confidential and must not be disclosed to any persons not directly concerned with the study without written permission from Axogen, Corp. However, authorized regulatory officials and Axogen, Corp. personnel (or their representatives) ... | [] |
NCT03940963 | 12 | REGULATORY CONSIDERATIONS | 12. REGULATORY CONSIDERATIONS | [] |
NCT03940963 | 12.1 | Amendments | 12.1 Amendments The site Investigator will not make any changes to this protocol without prior written consent from the Sponsor and subsequent approval by the IRB/IEC. Any change to the protocol, whether an overall change or a change for specific study center(s), must be handled as a protocol amendment. Any amendment t... | [] |
NCT03940963 | 12.2 | Protocol Deviations | 12.2 Protocol Deviations This study is intended to be conducted as described in this protocol. In the event of a significant deviation from the protocol due to an emergency, accident, or mistake, the site Investigator or designee must notify the sponsor as soon as possible. This will allow for an early, joint decision ... | [] |
NCT03940963 | 12.3 | Sponsor and Site Investigator Responsibilities | 12.3 Sponsor and Site Investigator Responsibilities The Sponsor and participating site Investigators shall be responsible for the conduct of this clinical study in compliance with the study protocol, FDA 21 CFR parts 50, and 56, ICH/GCP guidelines (ICH E6), ISO 14155:2011, and applicable local regulatory requirements a... | [] |
NCT03940963 | 13 | REFERENCES | 13. REFERENCES - Provost, N., Bonaldi, V. M., Sarazin, L., Cho, K. H. & Chhem, R. K. "Amputation stump neuroma: ultrasound features" J. Clin. Ultrasound. 25 Feb. 1997: 85-89. - Nashold, B. S., Jr, Goldner, J. L., Mullen, J. B. & Bright, D. S. "Long-term pain control by direct peripheral-nerve stimulation" J. Bone Joint... | [
"APPENDIX A: INVESTIGATOR AGREEMENT",
"Agreement Signatures",
"APPENDIX B: SCHEDULE OF ASSESSMENTS",
"APPENDIX C: INSTRUCTIONS FOR USE Axoguard® Nerve Cap (LB-580 R04)"
] |
NCT03948646 | 1 | BACKGROUND AND CLINICAL RATIONALE | 1 BACKGROUND AND CLINICAL RATIONALE Hyperhidrosis is a disorder of excessive sweating beyond what is expected for thermoregulatory needs and environmental conditions. Primary hyperhidrosis (excessive sweating without an alternative origin) is localized, characteristically symmetric, and may involve several anatomic are... | [
"Nonclinical Safety Conclusions",
"Prior Human Experience",
"Clinical Safety Conclusions",
"Clinical Efficacy Conclusions",
"Clinical Pharmacokinetics Conclusions",
"Risk to Subjects"
] |
NCT03948646 | 2 | STUDY DESIGN | 2 STUDY DESIGN This is a multicenter, randomized, double-blinded, vehicle-controlled, Phase 3 study to evaluate the safety and efficacy of topically applied sofpironium bromide gel, 15% in subjects with primary axillary hyperhidrosis. Approximately 350 subjects, at up to approximately 45 clinical sites in the US, will ... | [] |
NCT03948646 | 3 | STUDY OBJECTIVES AND ASSESSMENTS | 3 STUDY OBJECTIVES AND ASSESSMENTS The purpose of this Phase 3 study is to assess the safety, local tolerability, and efficacy of sofpironium bromide gel, 15% when applied topically in subjects with primary axillary hyperhidrosis. | [] |
NCT03948646 | 3.1 | Study Objectives | 3.1 Study Objectives - To evaluate the safety and local tolerability of sofpironium bromide gel, 15% when applied topically to subjects with primary axillary hyperhidrosis. - To evaluate the effect of sofpironium bromide gel, 15% on hyperhidrosis disease severity as it relates to sweat production, patient-reported outc... | [] |
NCT03948646 | 3.2 | Study Assessments | 3.2 Study Assessments
Safety Measures: The following safety assessment measures will be conducted to evaluate the safety and local tolerability of sofpironium bromide gel, 15%: - Physical examination - Vital signs - Clinical laboratory assessments - Urinalysis - Collection of AEs - Subject-reported local tolerability ... | [
"Safety Measures:",
"Efficacy Assessments:"
] |
NCT03948646 | 4 | STUDY POPULATION | 4 STUDY POPULATION | [] |
NCT03948646 | 4.1 | Number of Subjects | 4.1 Number of Subjects Approximately 350 subjects, at up to approximately 45 clinical sites, will be randomized to receive either sofpironium bromide gel, 15% or vehicle gel in a 1:1 ratio to obtain approximately 300 evaluable subjects at the end of study. | [] |
NCT03948646 | 4.2 | Inclusion Criteria | 4.2 Inclusion Criteria Subjects must fulfill all of the following criteria to be eligible for study admission: - 1. 0DOHRUIHPDOHVXEMHFW9 years of age in good general health. - 2. Diagnosis of primary axillary hyperhidrosis in the opinion of the Investigator that meets all the following criteria: - a. HDSM-Ax-7[2](#page... | [] |
NCT03948646 | 4.3 | Exclusion Criteria | 4.3 Exclusion Criteria Meeting any of the following criteria will exclude a subject from participating in this study: - 1. In the Investigator's opinion, diagnosis of any skin or subcutaneous tissue conditions of the axilla(e), (i.e., the axillary area should be deemed otherwise "normal", besides the hyperhidrosis diag... | [] |
NCT03948646 | 5 | INVESTIGATIONAL PRODUCT (IP) | 5 INVESTIGATIONAL PRODUCT (IP) Sofpironium bromide gel is an anhydrous gel formulation containing the drug substance in a gel base comprising hydroxypropyl cellulose National Formulary (NF), hexylene glycol NF, isopropyl myristate NF, citric acid anhydrous United States Pharmacopeia (USP), and alcohol dehydrated USP. S... | [] |
NCT03948646 | 5.1 | Storage of Investigational Product | 5.1 Storage of Investigational Product The investigational product must be stored in a secure area with access limited to the Investigator and authorized site staff and administered only to subjects entered into the clinical study, at no cost to the subject, in accordance with the conditions specified in this protocol.... | [] |
NCT03948646 | 5.2 | Instructions for Use and Administration of Investigational Product | 5.2 Instructions for Use and Administration of Investigational Product Investigational product kit cartons will be provided to each site and will include one individual plastic pump container per each carton. Each carton will also contain 2 applicators. An investigational plastic pump container will contain sufficient ... | [] |
NCT03948646 | 5.3 | Instructions for the Subjects | 5.3 Instructions for the Subjects Subjects will be instructed to apply the investigational product every day, at night prior to bedtime, using a supplied applicator as follows (a written instruction sheet and access to a study product application video and digital mobile application will be supplied to the subject): - ... | [
"Important information:",
"On the day of a clinic study visit:"
] |
NCT03948646 | 5.4 | Procedures for Blinding and Unblinding | 5.4 Procedures for Blinding and Unblinding This is a double-blind study. All study treatments (sofpironium bromide gel, 15%, and vehicle gel) are identical in color, shape, size, and packaging in order to maintain the blind. Subjects, Sponsor personnel, Investigator staff, persons performing the assessments, clinical o... | [] |
NCT03948646 | 6 | CONCOMITANT MEDICATIONS/TREATMENTS | 6 CONCOMITANT MEDICATIONS/TREATMENTS Information will be recorded on concomitant medications/treatments (e.g., aspirin, Tylenol, birth control pills, intrauterine device [IUD], vitamins) taken during study participation, or which may require a washout for study participation. Every effort should be made to keep dosing ... | [] |
NCT03948646 | 6.1 | Permissible Medications/Treatments | 6.1 Permissible Medications/Treatments Therapy considered necessary for the subject's welfare may be given at the discretion of the Investigator. If the permissibility of a specific medication/treatment is in question, the Medical Monitor should be contacted. Subjects will be instructed to not apply any contraindicated... | [] |
NCT03948646 | 6.2 | Prohibited Medications/Treatments | 6.2 Prohibited Medications/Treatments The decision to administer a prohibited medication/treatment is made with the safety of the study participant as the primary consideration. When possible, Brickell Biotech's Medical Monitor should be notified before a prohibited medication/treatment is administered. Prior to the in... | [] |
NCT03948646 | 7 | PROCEDURES | 7 PROCEDURES The timing of each assessment is listed in the Time and Events Table [\(Section 7.1\)](#page-28-0). Each subject will report for 13 distinct visits (over 11-15 weeks). All Screening assessment results must be completed and reviewed prior to the GSP1 Visit (within 31 days). Therefore, none of the Screening ... | [] |
NCT03948646 | 7.1 | Time and Events Table | 7.1 Time and Events Table | Visit | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | |--------------------------------------------------------------------------------|--------------------------------------|-----------|-----------|---------------------------|-------------------|--------------------|--------------... | [] |
NCT03948646 | 7.2 | Visit-Specific Procedures | 7.2 Visit-Specific Procedures | [] |
NCT03948646 | 7.2.1 | Visit 1: Screening (Days -31 to 0) | 7.2.1 Visit 1: Screening (Days -31 to 0) Written informed consent must be obtained prior to any study-related procedures. Potential subjects will be screened within 45 days prior to Visit 4 (Rescreening/Baseline) to assess their eligibility to enter the study. Only eligible subjects with axillary hyperhidrosis will be ... | [] |
NCT03948646 | 7.2.2 | Visits 2 and 3: GSP1 and GSP2 | 7.2.2 Visits 2 and 3: GSP1 and GSP2 Visit 2 should occur no more than 31 days after the initial screening visit (Visit 1); both Visits 2 and 3 should occur within 14 days of Rescreening/Baseline Visit 4. Any washouts required for prohibited medications (see [Section 4.3\)](#page-21-0) must be completed prior to Visit 2... | [] |
NCT03948646 | 7.2.3 | Visit 4: GSP3 (Day 1; Rescreening/Baseline) +14 Days of Visit 2 | 7.2.3 Visit 4: GSP3 (Day 1; Rescreening/Baseline) +14 Days of Visit 2 No more than 14 days may elapse between Visit 2 (GSP1) and Visit 4 (GSP3; Day 1). The following activities will be conducted: - Collect and review subject medical history and demographics. - Perform physical examination including collection of height... | [] |
NCT03948646 | 7.2.4 | Visit 5: Day 8 ± 2 Days | 7.2.4 Visit 5: Day 8 ± 2 Days The following activities will be conducted: - Collect vital signs (blood pressure, heart rate, respiratory rate, and temperature) after subject has been seated for ≥2 minutes (se[e Section 8.1.2\)](#page-37-1). - Subject to complete the GSP assessment; will be conducted from 7:00 am to 11:... | [] |
NCT03948646 | 7.2.5 | Visit 6: Day 15 ± 2 Days | 7.2.5 Visit 6: Day 15 ± 2 Days The following activities will be conducted: - Collect vital signs (blood pressure, heart rate, respiratory rate, and temperature) after subject has been seated for ≥2 minutes. - Subject to complete the GSP assessment; will be conducted from 7:00 am to 11:00 am. - Subject to complete HDSM-... | [] |
NCT03948646 | 7.2.6 | Visit 7: Day 22 ± 2 Days | 7.2.6 Visit 7: Day 22 ± 2 Days The following activities will be conducted: - Collect vital signs (blood pressure, heart rate, respiratory rate, and temperature) after subject has been seated for ≥2 minutes. - Subject to complete the GSP assessment; will be conducted from 7:00 am to 11:00 am. - Subject to complete HDSM-... | [] |
NCT03948646 | 7.2.7 | Visit 8: Day 29 ± 2 Days | 7.2.7 Visit 8: Day 29 ± 2 Days The following activities will be conducted: - Collect vital signs (blood pressure, heart rate, respiratory rate, and temperature) after subject has been seated for ≥2 minutes. - Subject to complete the GSP assessment; will be conducted from 7:00 am to 11:00 am. - Subject to complete HDSM-... | [] |
NCT03948646 | 7.2.8 | Visit 9: Day 36 ± 2 Days | 7.2.8 Visit 9: Day 36 ± 2 Days The following activities will be conducted: - Collect vital signs (blood pressure, heart rate, respiratory rate and temperature) after subject has been seated for ≥2 minutes. - Subject to complete the GSP assessment; will be conducted from 7:00 am to 11:00 am. - Subject to complete HDSM-A... | [] |
NCT03948646 | 7.2.9 | Visits 10 and 11: GSP4 (Day 41) ± 2 Days and GSP 5 (Day 42) ± 2 Days | 7.2.9 Visits 10 and 11: GSP4 (Day 41) ± 2 Days and GSP 5 (Day 42) ± 2 Days Visits 10 and 11 will occur as separate visits on Days 41 and 42. The following activities will be conducted: - Subject to complete the GSP assessment; will be conducted from 7:00 am to 11:00 am. - Subject to complete HDSM-Ax assessment. - o Sub... | [] |
NCT03948646 | 7.2.10 | Visit 12: GSP6 (Day 43; End of Treatment) ± 2 Days | 7.2.10 Visit 12: GSP6 (Day 43; End of Treatment) ± 2 Days The following activities will be conducted: - Collect vital signs (blood pressure, heart rate, respiratory rate and temperature) after subject has been seated for ≥2 minutes. - Subject to complete the GSP assessment; will be conducted from 7:00 am to 11:00 am. -... | [] |
NCT03948646 | 7.2.11 | Visit 13: Follow-up (Day 57) ± 3 Days | 7.2.11 Visit 13: Follow-up (Day 57) ± 3 Days The following activities will be conducted: - Collect vital signs (blood pressure, heart rate, respiratory rate and temperature) after subject has been seated for ≥2 minutes. - Subject to complete the GSP assessment; will be conducted from 7:00 am to 11:00 am. - Subject to c... | [] |
NCT03948646 | 7.3 | Unscheduled Visits | 7.3 Unscheduled Visits If a subject is seen for an unscheduled visit, an assessment and record of AEs should be completed, as appropriate. Additional evaluations should be performed as necessary, and the appropriate CRF pages should be completed. | [] |
NCT03948646 | 7.4 | Early Discontinuation of Subjects | 7.4 Early Discontinuation of Subjects It is the right and duty of the Investigator to discontinue a subject's participation if the subject's health or wellbeing is threatened by continuation in the study. In the event of premature discontinuation, the Investigator should determine the primary reason for discontinuation... | [] |
NCT03948646 | 8 | RESPONSE MEASURES AND SUMMARY OF DATA COLLECTION METHODS | 8 RESPONSE MEASURES AND SUMMARY OF DATA COLLECTION METHODS | [] |
NCT03948646 | 8.1 | Safety Measures | 8.1 Safety Measures The following safety assessment measures will be conducted as indicated in [Section 7.1,](#page-28-0) Time and Events Table. - Physical examination - Vital signs (blood pressure, pulse rate, respiratory rate, and temperature) - Laboratory tests (hematology, chemistry, urinalysis) and pregnancy testi... | [] |
NCT03948646 | 8.1.1 | Physical Examination | 8.1.1 Physical Examination Physical examination will include assessments of the head, eyes, ears, nose, throat, skin, thyroid, neurological, lungs, cardiovascular, abdomen (liver and spleen), lymph nodes, and extremities. Height and weight will also be measured and recorded. | [] |
NCT03948646 | 8.1.2 | Vital Signs | 8.1.2 Vital Signs Subjects should be seated for ≥2 minutes prior to measurements. Pulse rate (bpm) will be counted over 60 seconds. Blood pressure (mmHg) will be measured with a sphygmomanometer. Vital sign measurements will include systolic and diastolic blood pressure, pulse rate, respiratory rate, and temperature. | [] |
NCT03948646 | 8.1.3 | Clinical Laboratory Assessments | 8.1.3 Clinical Laboratory Assessments Hematology, clinical chemistry, urinalysis, and additional parameters to be tested are listed below:
Hematology | Platelet count | RBC Indices: | Automated WBC Differential: | |------------------------------|-----------------------------------------------------|-------------------... | [
"Hematology",
"Clinical Chemistry",
"Routine Urinalysis",
"Other Screening Tests"
] |
NCT03948646 | 8.1.4 | Adverse Events | 8.1.4 Adverse Events Adverse events (AEs; s[ee Section](#page-40-0) 9.2) will be collected for all untoward medical occurrences in a subject entered into this clinical study (e.g., signed consent), whether or not a pharmaceutical product has been administered. Any event, including local tolerability assessments (se[e S... | [] |
NCT03948646 | 8.1.5 | Local Tolerability Assessments | 8.1.5 Local Tolerability Assessments Local tolerability assessments (see [Appendix 5\)](#page-72-1) will be evaluated through assessment of symptoms at the drug application site. These assessments are to be performed for both axillae individually. Subject assessments will be made prior to the Investigator assessments. ... | [] |
NCT03948646 | 8.1.6 | Subject Assessments | 8.1.6 Subject Assessments Subjects must complete ALL self-assessments while at the clinic (i.e., HDSM-Ax, DLQI, PGI-S, PGI-C) prior to assessments being made by the Investigator. Please see [Appendix 2](#page-63-0) and [Appendix 3](#page-66-1) (HDSM-Ax by age; also includes PGI-S and PGI-C) and [Appendix 4](#page-69-0)... | [] |
NCT03948646 | 8.1.7 | Allergic Contact Dermatitis (Skin Sensitization) Assessment | 8.1.7 Allergic Contact Dermatitis (Skin Sensitization) Assessment Allergic contact dermatitis (ACD), as an AE, may manifest as moderate/severe pruritis and moderate/severe erythema with or without vesicles/bullae. In the case of a suspected AE of ACD, the medical monitor should be contacted to discuss the case. If the ... | [] |
NCT03948646 | 8.2 | Summary of Methods of Data Collection | 8.2 Summary of Methods of Data Collection This protocol will utilize validated 21 Code of Federal Regulations (CFR) Part 11 compliant electronic data capture (EDC) software and eCOA software to collect required study data. The Investigator must ensure that data are properly recorded on each subject's eCRFs, eCOAs, and ... | [] |
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