protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT05186805 | 5.1.1 | Description, Packaging, and Labeling | 5.1.1 Description, Packaging, and Labeling The description of the study drug, tapinarof cream, 1%, is presented in Table 2. Table 2: Tapinarof Cream  All labels for tapinarof cream, 1% to be distributed in the participating countries will meet all applicable requirements of those countries. | [] |
NCT05186805 | 5.1.2 | Storage | 5.1.2 Storage All study drug must be stored in a secure, environmentally controlled and monitored (manual or automated) area in accordance with the labeled storage conditions, with access limited to the Investigator and authorized site staff. The study drug storage temperature range will be provided in the study refere... | [] |
NCT05186805 | 5.1.3 | Handling and Disposal | 5.1.3 Handling and Disposal Under normal conditions of handling and administration, study drug is not expected to pose significant safety risks to site staff. In the case of unintentional occupational exposure notify the monitor, Medical Monitor and/or the Sponsor study contact. Arrangements will be made for used and u... | [] |
NCT05186805 | 5.1.4 | Preparation | 5.1.4 Preparation No special preparation of study drug is required. | [] |
NCT05186805 | 5.1.5 | Administration of Study Drug | 5.1.5 Administration of Study Drug Study drug will be dispensed to subjects and/or their caregivers at the clinical site in appropriately labeled tubes. Subjects and/or caregivers will take the tubes home and self-administer study drug (or have caregiver(s) apply if necessary) to affected areas QD, except on clinic vis... | [] |
NCT05186805 | 5.2 | Randomization/Treatment Assignment | 5.2 Randomization/Treatment Assignment All subjects will receive tapinarof cream, 1% QD for 27 days. | [] |
NCT05186805 | 5.3 | Blinding | 5.3 Blinding This will be an open label study. | [] |
NCT05186805 | 5.4 | Compliance with Study Drug Administration | 5.4 Compliance with Study Drug Administration At Baseline, study staff will provide the subject and/or caregiver with detailed instructions concerning protocol requirements and use of study drug. Additionally, subjects and/or caregivers will be asked to complete a daily diary with the time of each application of study ... | [] |
NCT05186805 | 5.5 | Treatment after the End of the Study | 5.5 Treatment after the End of the Study Subjects will not receive any additional treatment with the study drug from the Sponsor after completion of the study (with the exception of eligible subjects who enroll in the open-label, long-term safety study) because the indication being studied is not life threatening or se... | [] |
NCT05186805 | 5.6 | Prior and Concomitant Therapy | 5.6 Prior and Concomitant Therapy Any medication (including over the counter or prescription medication, vitamins and/or herbal supplements) administered to the subject up to 30 days before the Screening visit, at the time of enrollment, and during the study must be recorded in the CRF along with the reason for use. Th... | [] |
NCT05186805 | 5.6.1 | Permitted Medications and Nondrug Therapies | 5.6.1 Permitted Medications and Nondrug Therapies Concomitant medications for medical treatment of other conditions are allowed under the condition that the dosage and administration of these treatments is not planned to change from the Baseline visit to the completion of the treatment phase (Day 28) and that the medic... | [] |
NCT05186805 | 5.6.2 | Prohibited Medications and Nondrug Therapies | 5.6.2 Prohibited Medications and Nondrug Therapies Medications and nondrug therapies that are prohibited throughout the study duration are described in the Exclusion Criteria (Section 4.3). A list of prohibited medications, emollients and nondrug therapies may be provided as a separate document. If a subject chooses to... | [] |
NCT05186805 | 6 | Study Assessments and Procedures | 6 Study Assessments and Procedures Study procedures and assessments are summarized in the Schedule of Assessments and in Section 6. Adherence to the study design requirements, including those specified in the Schedule of Assessments (Table 1) are essential and required for study conduct. Protocol waivers or exemptions ... | [] |
NCT05186805 | 6.1 | Demography, Medical History, and Baseline Characteristics | 6.1 Demography, Medical History, and Baseline Characteristics | [] |
NCT05186805 | 6.1.1 | Demographics | 6.1.1 Demographics Demographic information collected will include age, sex, race, ethnicity, and Fitzpatrick skin type. Information on Fitzpatrick skin type can be found in Appendix 2. | [] |
NCT05186805 | 6.1.2 | Medical History | 6.1.2 Medical History Medical history will be collected to ensure subjects are eligible for participation in the study (per inclusion Section 4.2 and exclusion Section 4.3 criteria). Data collected will include month and year of AD diagnosis, allergic conditions, and cardiovascular (CV) medical history risk factors (in... | [] |
NCT05186805 | 6.2 | Efficacy Assessments | 6.2 Efficacy Assessments To minimize inter-observer variability, Investigators and evaluators/raters will be trained on each of the required assessments during an Investigator meeting, site initiation visit, and/or utilizing online assessments before enrolling subjects at their study site. Only trained evaluators/rater... | [] |
NCT05186805 | 6.2.1 | Assessments Completed by Investigator | 6.2.1 Assessments Completed by Investigator | [] |
NCT05186805 | 6.2.1.1 | Validated Investigator Global Assessment | 6.2.1.1 Validated Investigator Global Assessment The vIGA-AD™ of disease severity will be assessed at every clinic visit. The vIGA-AD™ is a global assessment of the current state of the disease. It is a 5-point morphological assessment of overall disease severity and will be determined according to the categories descr... | [] |
NCT05186805 | 6.2.1.2 | Body Surface Area Affected | 6.2.1.2 Body Surface Area Affected The assessment of the %BSA affected is an estimate of the percentage of total involved skin with AD. For the purpose of clinical estimation, the total palmar surface of the subject's palm and digits may be assumed to be approximately equivalent to 1% BSA. The %BSA affected by AD will ... | [] |
NCT05186805 | 6.2.2 | Eczema Area and Severity Index | 6.2.2 Eczema Area and Severity Index The EASI will be assessed at every clinic visit beginning with the Baseline visit. It quantifies the severity of a subject's AD based on both lesion severity and the %BSA affected (Hanifin, 2001). The EASI is a composite score ranging from 0 to 72 that takes into account the degree ... | [] |
NCT05186805 | 6.2.3 | Assessments Completed by Subject | 6.2.3 Assessments Completed by Subject | [] |
NCT05186805 | 6.2.3.1 | Peak Pruritus Numeric Rating Scale | 6.2.3.1 Peak Pruritus Numeric Rating Scale The PP NRS is a scale used to quickly assess itch/pruritus severity over a 24-hour period. The subject or caregiver will utilize the scale to assess peak pruritus QD and record the results in their daily diaries. The itch rating can be done before or after study drug administr... | [
"PP-NRS"
] |
NCT05186805 | 6.3 | Safety Assessments | 6.3 Safety Assessments | [] |
NCT05186805 | 6.3.1 | Adverse Events | 6.3.1 Adverse Events All AEs and SAEs will be collected from the time the subject signs the Informed Consent Form (ICF) until the final visit/contact with the subject. Additional safety information, including the definition of an AE and the methods for recording, evaluating, and assessing causality of AEs and the proce... | [] |
NCT05186805 | 6.3.2 | Brief Physical Examination | 6.3.2 Brief Physical Examination A brief physical examination will include, at a minimum, assessments of the skin, lungs, cardiovascular system, and abdomen (liver and spleen). Assess for changes in onset of menses (female participants) or sexual activity (male or female participants). Determine if there is a need for ... | [] |
NCT05186805 | 6.3.3 | Vital Signs | 6.3.3 Vital Signs Vital signs will be measured before blood collection for clinical laboratory assessments and PK analysis (where applicable) and will include measurements of systolic and diastolic blood pressure, pulse rate, and body temperature. Subjects should be in a seated position for at least 5 minutes before vi... | [] |
NCT05186805 | 6.3.4 | Clinical Safety Laboratory Assessments | 6.3.4 Clinical Safety Laboratory Assessments All protocol-required laboratory assessments must be conducted in accordance with the Study Reference Manual or Laboratory Manual and the protocol Schedule of Assessments (Table 1). Laboratory requisition forms must be completed, and samples must be clearly labeled with the ... | [] |
NCT05186805 | 6.3.5 | Investigator Assessed Local Tolerability Scale | 6.3.5 Investigator Assessed Local Tolerability Scale At each specified study visit, the Investigator (or qualified evaluator) will assess the presence and overall degree of irritation at the application sites according to a 5-point LTS. The score will ideally represent an "average" across all application sites. To the ... | [] |
NCT05186805 | 6.4 | Treatment of Study Drug Overdose | 6.4 Treatment of Study Drug Overdose For this study, accidental or intentional oral ingestion of drug product will be considered an overdose. Ingestion of a 30-gram tube of tapinarof cream, 1% would result in an oral dose of 300 mg. The Sponsor does not recommend specific treatment for an overdose; however, in the even... | [] |
NCT05186805 | 6.5 | Pharmacokinetics | 6.5 Pharmacokinetics Blood samples for PK analysis of tapinarof cream, 1% will be collected at timepoints indicated in the Schedule of Assessments (Table 1) and Section 7. Blood samples for PK should not be collected from any anatomic site where study drug has been applied in order to minimize potential contamination. ... | [] |
NCT05186805 | 6.6 | Virtual Assessments | 6.6 Virtual Assessments In the event that a subject cannot attend their regularly scheduled study visits in person due to a COVID-19 like situation necessitating a limit on in-person contact, the Investigator may perform safety and efficacy assessments by phone or video. Source documentation should note if the visit wa... | [] |
NCT05186805 | 7 | Timing of Procedures and Assessments | 7 Timing of Procedures and Assessments This section lists the procedures and assessments to be performed at scheduled timepoints during the study as outlined in the Schedule of Assessments (Table 1). Information on study procedures and assessments is provided in Section 6. - Any change in timing or any addition of a ti... | [] |
NCT05186805 | 7.1 | Visit 1; Screening Period (Day -30 to Day -1) | 7.1 Visit 1; Screening Period (Day -30 to Day -1) After the subject has signed the consent/assent form, potential study subjects will undergo Screening procedures and assessments to confirm eligibility to participate in the study. Screening assessments will include the following: - Demography recording - Fitzpatrick sk... | [] |
NCT05186805 | 7.2 | Visit 2; Baseline (Day 1) | 7.2 Visit 2; Baseline (Day 1) On Day 1, subjects will be reassessed to confirm continued eligibility to participate in the study. All subjects who continue to meet study eligibility criteria will be enrolled and receive treatment. The following additional procedures and assessments will be performed at the Baseline Vis... | [] |
NCT05186805 | 7.3 | Visit 3; Week 1 (Day 8 ±2 Days) | 7.3 Visit 3; Week 1 (Day 8 ±2 Days) The following procedures and assessments will be performed at Visit 3: - Brief physical exam - Vital signs measurement - Collect and dispense study drug - Review instructions on how to apply study drug - Collect study drug subject diary and PP-NRS diary and review for compliance - Di... | [] |
NCT05186805 | 7.4 | Phone Contact at Day 15 ±2 Days | 7.4 Phone Contact at Day 15 ±2 Days Subjects or their caregivers will be contacted by phone at Day 15 to review instructions on how to apply study drug and to record AEs and concomitant medication use. Subjects should be reminded to complete their daily diary and bring it with them to the next clinic visit. | [] |
NCT05186805 | 7.5 | Visit 4; Day 28 ±2 Days | 7.5 Visit 4; Day 28 ±2 Days The following procedures and assessments will be performed at Visit 5: - Brief physical exam - Urine pregnancy test (females of child-bearing potential) - Blood sample collection for clinical laboratory tests (serum chemistry, hematology, diagnostic tests) - Urinalysis - Vital signs measurem... | [] |
NCT05186805 | 7.6 | Visit 5; Follow-Up (Day 35 ±3 Days) | 7.6 Visit 5; Follow-Up (Day 35 ±3 Days) Subjects who do not enroll in the open-label long-term safety study will return to the study site 7-10 days after Day 28 to complete follow-up assessments as follows: - Brief physical examination - If needed, blood sample collection for clinical laboratory tests - If needed, urin... | [] |
NCT05186805 | 7.7 | Early Termination Visit | 7.7 Early Termination Visit Subjects who withdraw early from the study will be asked to return to the study site to complete Early Termination assessments as follows: - Brief physical examination - Urine pregnancy test (females of child-bearing potential) - Blood sample collection for clinical laboratory tests - Urinal... | [] |
NCT05186805 | 7.8 | Unscheduled Visit | 7.8 Unscheduled Visit Subjects may have an unscheduled visit for AE follow-up, study drug dispensation, make-up for a missed visit, or other reason. The following assessments may be performed as needed: • Brief physical examination - Blood sample collection for clinical laboratory tests (serum chemistry, hematology, di... | [] |
NCT05186805 | 7.9 | End of Study | 7.9 End of Study The end of study is defined as when the last active subject has completed the Follow up Visit (if subject does not enroll in the separate open-label, long-term safety study) OR the last active subject has completed the 27 days of treatment in this study (if subject is eligible and enrolls in the separa... | [] |
NCT05186805 | 8 | Safety Monitoring and Reporting | 8 Safety Monitoring and Reporting | [] |
NCT05186805 | 8.1 | Adverse Events, Serious Adverse Events, and Adverse Events of Special Interest | 8.1 Adverse Events, Serious Adverse Events, and Adverse Events of Special Interest The Investigator or site staff is responsible for detecting, documenting, and reporting events that meet the definition of an AE, SAE, or adverse events of special interest (AESIs). At each visit/contact, subjects should be questioned in... | [] |
NCT05186805 | 8.1.1 | Definition of Adverse Events | 8.1.1 Definition of Adverse Events An AE is any untoward medical occurrence in a subject temporally associated with the use of a medicinal product, whether considered causally related or not related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory fi... | [] |
NCT05186805 | 8.1.2 | Definition of Serious Adverse Event | 8.1.2 Definition of Serious Adverse Event If an event is not an AE per Section 8.1.1, then it cannot be an SAE even if serious conditions are met (e.g., hospitalization for signs/symptoms of the disease under study, death due to progression of disease, etc.). - An SAE is any untoward medical occurrence that, at any dos... | [] |
NCT05186805 | 8.1.3 | Adverse Events of Special Interest | 8.1.3 Adverse Events of Special Interest In prior clinical studies, contact dermatitis, folliculitis, and headache have been identified as AEs of particular clinical importance and will be reported as AESIs in this study. In each case study drug may be continued or discontinued, based on Investigator judgment, and may ... | [
"Contact Dermatitis",
"Headache",
"Follicular Event"
] |
NCT05186805 | 8.2 | Classification of Adverse Events | 8.2 Classification of Adverse Events | [] |
NCT05186805 | 8.2.1 | Assigning Severity Rating for Adverse Events | 8.2.1 Assigning Severity Rating for Adverse Events | [] |
NCT05186805 | 8.2.1.1 | Criteria for Determining Adverse Event Severity | 8.2.1.1 Criteria for Determining Adverse Event Severity The Investigator will make an assessment of the severity of each AE and SAE according to the National Cancer Institute CTCAE, v. 5.0, 2017. For terms not specified with the CTCAE, the criteria in Table 5 should be used to determine the grade severity. Table 5: Cri... | [] |
NCT05186805 | 8.2.1.2 | Toxicity Management Criteria | 8.2.1.2 Toxicity Management Criteria | [] |
NCT05186805 | 8.2.1.2.1 | Grade 1 or Grade 2 Adverse Event | 8.2.1.2.1 Grade 1 or Grade 2 Adverse Event Subjects who develop a Grade 1 or Grade 2 AE may continue investigational product at the discretion of the Investigator. Subjects who choose to withdraw from study due to a Grade 1 or 2 AE should have study withdrawal evaluations completed. b. Self-care activities of daily liv... | [] |
NCT05186805 | 8.2.1.2.2 | Grade 3 Adverse Event | 8.2.1.2.2 Grade 3 Adverse Event Subjects who develop a Grade 3 AE should be managed as follows: - If the Investigator has compelling evidence that the Grade 3 AE has not been caused by investigational product, then dosing may continue after discussion with the Medical Monitor. - Subjects who develop a Grade 3 AE that t... | [] |
NCT05186805 | 8.2.1.2.3 | Grade 4 Adverse Event | 8.2.1.2.3 Grade 4 Adverse Event Subjects who develop a Grade 4 AE should have investigational product permanently discontinued. Subjects experiencing Grade 4 AEs requiring permanent discontinuation of investigational product should be followed weekly until resolution or stability of the AE and encouraged to have withdr... | [] |
NCT05186805 | 8.2.1.2.4 | Folliculitis | 8.2.1.2.4 Folliculitis Subjects using tapinarof topically may experience folliculitis. The majority if these events are mild and moderate and do not require intervention or interruption in study drug use. On close inspection, the morphology is similar to that of keratoses pilaris suggesting that the potential mechanism... | [] |
NCT05186805 | 8.2.1.2.5 | Other Management Criteria | 8.2.1.2.5 Other Management Criteria The Medical Monitor should be notified if any of the following occur: • Severe signs or symptoms, or significant changes in any of the safety assessments, that put the safety of the subject at risk (e.g., laboratory tests or vital signs, etc.) as judged by the Investigator. | [] |
NCT05186805 | 8.2.2 | Assigning Causal Relationship to Study Drug | 8.2.2 Assigning Causal Relationship to Study Drug The Principal Investigator or sub-Investigator is to make the causality assessment. The reasonable possibility of the relationship of an AE to study drug is to be assessed with careful medical consideration at the time of evaluation of an AE. The following definitions a... | [] |
NCT05186805 | 8.3 | Time Period and Frequency for Event Assessment and Follow-Up | 8.3 Time Period and Frequency for Event Assessment and Follow-Up | [] |
NCT05186805 | 8.3.1 | Adverse Event Reporting | 8.3.1 Adverse Event Reporting All AEs will be collected from the time of signed informed consent until the final visit. Any AEs assessed as related to study participation (e.g., protocol-mandated procedures, invasive tests, or change in existing therapy) will be collected from the time a subject consented to participat... | [] |
NCT05186805 | 8.3.2 | Follow-Up of Adverse Events | 8.3.2 Follow-Up of Adverse Events After the initial AE/SAE report, the Investigator is required to proactively follow each subject at subsequent visits/contacts. All SAEs and nonserious AEs will be followed until resolution, until the condition stabilizes, until the event is otherwise explained, or until the subject is... | [] |
NCT05186805 | 8.4 | Reporting Procedures | 8.4 Reporting Procedures | [] |
NCT05186805 | 8.4.1 | Serious Adverse Event Reporting | 8.4.1 Serious Adverse Event Reporting When an Investigator determines that an AE meets the protocol definition of an SAE during the study, he/she must notify the Sponsor using an SAE Report Form within 24 hours of the study site personnel's knowledge of the event, regardless of the Investigator assessment of the relati... | [] |
NCT05186805 | 8.4.2 | Regulatory Reporting Requirements for Serious Adverse Events | 8.4.2 Regulatory Reporting Requirements for Serious Adverse Events Prompt notification by the Investigator to the Sponsor of SAEs (even for non-interventional post-marketing studies) is essential so that legal obligations and ethical responsibilities towards the safety of subjects and the safety of a product under clin... | [] |
NCT05186805 | 8.5 | Pregnancy Management and Reporting | 8.5 Pregnancy Management and Reporting Any female subject who becomes pregnant during the study will be withdrawn. Details will be collected for all pregnancies in female subjects and female partners of male subjects that begin after the start of dosing and through the Follow-up visit. Pregnancy is not automatically co... | [] |
NCT05186805 | 9 | Data Management | 9 Data Management For this study, subject data will be entered into the Sponsor-defined CRFs, transmitted electronically to the Sponsor or designee, and combined with data provided from other sources in a validated data system. Management of clinical data will be performed in accordance with applicable Sponsor standard... | [] |
NCT05186805 | 10 | Statistical Considerations and Data Analyses | 10 Statistical Considerations and Data Analyses This study will evaluate the safety, tolerability, PK, and efficacy of tapinarof cream, 1% in pediatric subjects with AD. | [] |
NCT05186805 | 10.1 | General Considerations | 10.1 General Considerations All study data will be summarized overall and by age group (2-6 years old, 7-11 years old, and 12-17 years old) using descriptive statistics. Categorical variables will be reported using frequency and percentage (e.g., gender, race). Continuous variables will be reported using number of subj... | [] |
NCT05186805 | 10.2 | Determination of Sample Size | 10.2 Determination of Sample Size There is no formal statistical hypothesis planned and the sample size is mainly based on feasibility and an estimated number of subjects needed to address the objectives of the study. | [] |
NCT05186805 | 10.3 | Analysis Populations | 10.3 Analysis Populations | [] |
NCT05186805 | 10.3.1 | Safety | 10.3.1 Safety All subjects who receive at least 1 application of study drug will be included in the Safety population. Subjects will be analyzed as treated. | [] |
NCT05186805 | 10.3.2 | Pharmacokinetic | 10.3.2 Pharmacokinetic All subjects who undergo plasma PK sampling and have evaluable concentration-time data for analysis will be included in the PK population. A sample that is below the quantification limit (BQL) of the assay is considered evaluable. | [] |
NCT05186805 | 10.4 | Planned Analyses | 10.4 Planned Analyses All safety, tolerability, PK, and efficacy measures over the course of the study will be presented. Details of planned analyses will be described in the Statistical Analysis Plan (SAP). | [] |
NCT05186805 | 10.4.1 | Disposition and Demographics | 10.4.1 Disposition and Demographics Demographic and baseline characteristics as well as medical history will be summarized using the Safety population, including frequency and percentages for categorical variables and mean, standard deviation, median, minimum, and maximum for continuous variables. | [] |
NCT05186805 | 10.4.2 | Safety Analyses | 10.4.2 Safety Analyses The Safety Population will be used in the analysis of safety data. Data will be listed by subject. No formal statistical comparisons will be made for safety data. The number and proportion of subjects with TEAEs will be summarized by system organ class, and preferred term for all TEAEs, all TEAEs... | [] |
NCT05186805 | 10.4.3 | Pharmacokinetic Analyses | 10.4.3 Pharmacokinetic Analyses The PK analysis set will be used in the analysis of PK data. Data will be listed and summarized. Listings will be sorted by subject, day, and time; summaries will be presented by day and time. Unless stated otherwise, descriptive summaries for continuous variables will include n, mean, S... | [] |
NCT05186805 | 10.4.4 | Efficacy Analyses | 10.4.4 Efficacy Analyses All efficacy analyses will be based on the Safety population. The efficacy endpoints are as follows: - Change in vIGA-AD™ score from Baseline at each study visit - Proportion of subjects who have a vIGA-AD™ score of clear or almost clear (0 or 1) at each study visit - Proportion of subjects wit... | [] |
NCT05186805 | 10.5 | Interim Analyses | 10.5 Interim Analyses No formal interim analyses will be performed, however the study team may review PK and safety data on an ongoing basis. This includes an analysis of the PK data after 25% of the subjects (n=9) have completed the study to re-assess the PK sampling scheme with the potential to eliminate the 5-hour p... | [] |
NCT05186805 | 10.6 | Handling of Missing Data | 10.6 Handling of Missing Data No imputations will be made for missing values. Summaries will be based on observed data only. Tapinarof Protocol No.: DMVT-505-2104 Dermavant Sciences, Inc. Clinical Study Protocol | [] |
NCT05186805 | 11 | Responsibilities | 11 Responsibilities | [] |
NCT05186805 | 11.1 | Investigator Responsibilities | 11.1 Investigator Responsibilities | [] |
NCT05186805 | 11.1.1 | Good Clinical Practice | 11.1.1 Good Clinical Practice The Investigator will ensure that this study is conducted in accordance with the principles of the "Declaration of Helsinki" (as amended in Edinburgh, Tokyo, Venice, Hong Kong, and South Africa), International Conference on Harmonization guidelines, or with the laws and regulations of the ... | [] |
NCT05186805 | 11.1.2 | Institutional Review Board/Independent Ethics Committee Approval | 11.1.2 Institutional Review Board/Independent Ethics Committee Approval This protocol and any accompanying material to be provided to the subject (such as advertisements, subject information sheets, or descriptions of the study used to obtain informed consent) will be submitted by the Investigator or on behalf of the I... | [] |
NCT05186805 | 11.1.3 | Informed Consent/Assent | 11.1.3 Informed Consent/Assent The Investigator is responsible for obtaining written informed consent/assent from each individual participating in this study after adequate explanation of the aims, methods, objectives, and potential hazards of the study and before undertaking any study-related procedures. The Investiga... | [] |
NCT05186805 | 11.1.4 | Confidentiality | 11.1.4 Confidentiality The Investigator must assure that subjects' anonymity will be strictly maintained and that their identities are protected from unauthorized parties. Only subject number, date of birth, and an identification code (i.e., not names) should be recorded on any form or biological sample submitted to th... | [] |
NCT05186805 | 11.1.5 | Study Files and Retention of Records | 11.1.5 Study Files and Retention of Records The Investigator must maintain adequate and accurate records to enable the conduct of the study to be fully documented and the study data to be subsequently verified. These documents should be classified into at least the following 2 categories: (1) Investigator's study file,... | [] |
NCT05186805 | 11.1.6 | Case Report Forms | 11.1.6 Case Report Forms For each subject enrolled, a case report form (CRF) must be completed and signed by the Investigator. This also applies to records for those subjects who fail to complete the study. If a subject withdraws from the study, the reason must be noted on the CRF. If a subject is withdrawn from the st... | [] |
NCT05186805 | 11.1.7 | Drug Accountability | 11.1.7 Drug Accountability The Investigator or designee (i.e., pharmacist) is responsible for ensuring adequate accountability of all used and unused investigational medicinal product. This includes acknowledgment of receipt of each shipment of study product (quantity and condition), subject dispensing records, and ret... | [] |
NCT05186805 | 11.1.8 | Inspections | 11.1.8 Inspections The Investigator should understand that source documents for this trial should be made available to appropriately qualified personnel from the Sponsor or its representatives, to IRBs or IECs, or to regulatory authority or health authority inspectors. | [] |
NCT05186805 | 11.1.9 | Protocol Compliance | 11.1.9 Protocol Compliance The Investigator is responsible for ensuring the study is conducted in accordance with the procedures and evaluations described in this protocol. | [] |
NCT05186805 | 11.2 | Sponsor Responsibilities | 11.2 Sponsor Responsibilities | [] |
NCT05186805 | 11.2.1 | Protocol Modifications | 11.2.1 Protocol Modifications Protocol modifications, except those intended to reduce immediate risk to study subjects, may be made only by the Sponsor. All protocol modifications must be submitted to the IRB or IEC and regulatory authorities in accordance with local requirements. Approval must be obtained before chang... | [] |
NCT05186805 | 11.2.2 | Study Report and Publications | 11.2.2 Study Report and Publications A clinical study report will be prepared and provided to the regulatory agency(ies). The Sponsor will ensure that the report meets the standards set out in the ICH Guideline for Structure and Content of Clinical Study Reports (ICH E3). Note that an abbreviated report may be prepared... | [] |
NCT05186805 | 11.2.3 | Posting of Information on Publicly Available Clinical Trial Registers | 11.2.3 Posting of Information on Publicly Available Clinical Trial Registers Study information from this protocol will be posted on publicly available clinical trial registers as required by applicable regulations. Results will be posted as required. | [] |
NCT05186805 | 11.3 | Joint Investigator/Sponsor Responsibilities | 11.3 Joint Investigator/Sponsor Responsibilities | [] |
NCT05186805 | 11.3.1 | Access to Information for Monitoring | 11.3.1 Access to Information for Monitoring In accordance with ICH Good Clinical Practice guidelines, the study monitor must have direct access to the Investigator's source documentation in order to verify the data recorded in the CRFs for consistency. The monitor is responsible for routine review of the CRFs at regula... | [] |
NCT05186805 | 11.3.2 | Access to Information for Auditing or Inspections | 11.3.2 Access to Information for Auditing or Inspections To ensure compliance with Good Clinical Practices and all applicable regulatory requirements, Dermavant Sciences, Inc. may conduct a quality assurance audit. Authorized representatives of Dermavant Sciences, Inc., a regulatory authority, an Independent Ethics Com... | [] |
NCT05186805 | 11.3.3 | Study Discontinuation | 11.3.3 Study Discontinuation The Sponsor reserves the right to terminate the study at any time. Should this be necessary, the Sponsor will arrange discontinuation procedures and notify the appropriate regulatory authority(ies), IRBs, and IECs. In terminating the study, the Sponsor and the Investigator will assure that ... | [] |
NCT05186805 | 12 | References | 12 References Bashaw ED, et al. Maximal usage trial: an overview of the design of systemic bioavailability trial for topical dermatological products. Ther Innovation & Regulatory Science. 2014;1-8 Bieber T. Atopic dermatitis. N Engl J Med. 2008 Apr 3;358(14):1483-94. Cappon GD and Hurtt ME. Developmental toxicity of th... | [] |
NCT05186805 | 13 | Appendices | 13 Appendices
Appendix 1: Criteria for Atopic Dermatitis Diagnosis Major Criteria (must have at least three) - Pruritus - Typical morphology and distribution: - Adults: flexural lichenification or linearity - Children and infants: involvement of facial and extensor surfaces - Chronic or chronically relapsing dermatiti... | [
"Appendix 1: Criteria for Atopic Dermatitis Diagnosis",
"Appendix 2: Fitzpatrick Skin Type Scale",
"Appendix 3: Validated Investigator Global Assessment scale for Atopic Dermatitis Instructions:",
"Notes:",
"For example:",
"Appendix 4: Calculation of Percent Body Surface Area Affected and Eczema Area Seve... |
NCT05244421 | 1 | PROGRAM SUMMARY | 1. PROGRAM SUMMARY Please provide a brief summary of your grant project including the needs to be addressed, the services provided, and the population served. Children's healthy physical, emotional, and social development is strongly influenced by their family circumstances. Research has shown that engaged, supportive ... | [] |
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