Protocol Number: MAP-7189 Version 1.3; 28 December 2017 CLINICAL STUDY PROTOCOL A Randomized, Multi-Center, Double-blind, Placebo Controlled, Parallel Group Trial to Evaluate Efficacy and Safety of Mayne Pharma’s Ivermectin 0.5% Lotion Compared to Sklice® Ivermectin 0.5% Lotion in the Treatment of Head Lice Protocol Identifying Number: MAP-7189 Sponsor: Mayne Pharma, LLC 1240 Sugg Parkway, Greenville, NC 27834 USA Phone: +1 (252) 717-1382 Fax: +1 (252) 758-8522 Funded by: Mayne Pharma, LLC Protocol Version 1.3; 28 December2017 1 Protocol Number: MAP-7189 Version 1.3; 28 December 2017 Table of Contents SIGNATURE PAGE.............................................................................................................................................. 2 Table of Contents ................................................................................................................................................. 3 Protocol Amendment 2 Summary of Changes....................................................................................................... 6 Protocol Amendment 1 Summary of Changes....................................................................................................... 7 List of Abbreviations ............................................................................................................................................. 8 INVESTIGATOR SIGNATURE PAGE ................................................................................................................... 9 Synopsis ............................................................................................................................................................ 10 1 Key Roles .............................................................................................................................................. 16 2 Study Introduction ........................................................................................................................................... 17 2.1 Background Information .............................................................................................................................. 17 2.2 Rationale .................................................................................................................................................... 17 2.3 Potential Risks and Benefits ........................................................................................................................ 18 2.3.1 Known Potential Risks ............................................................................................................................ 18 2.3.2 Known Potential Benefits ........................................................................................................................ 18 3 Objectives and Purpose ................................................................................................................................... 19 4 Study Design and Endpoints ............................................................................................................................ 19 4.1 Description of the Study Design .................................................................................................................. 19 4.2 Study Endpoint ........................................................................................................................................... 20 4.2.1 Primary Endpoint .................................................................................................................................... 20 4.2.2. Secondary Endpoint .............................................................................................................................. 20 5 Study Enrollment and Withdrawal .................................................................................................................... 20 5.1 Inclusion Criteria ......................................................................................................................................... 20 5.2 Exclusion Criteria ........................................................................................................................................ 21 5.3 Criteria for Inclusion of Minor Subjects ........................................................................................................ 22 5.4 Strategies for Recruitment and Retention .................................................................................................... 22 5.5 Subject Withdrawal and Termination ........................................................................................................... 22 5.5.1 Potential Reasons for Withdrawal ........................................................................................................... 22 5.5.2 Handling of Subject Withdrawals or Termination ..................................................................................... 23 5.6 Premature Suspension or Termination of Study .......................................................................................... 23 6 Study Drug ...................................................................................................................................................... 24 6.1 Study Agent (s) and Control Description ...................................................................................................... 24 6.1.1 Acquisition .............................................................................................................................................. 24 6.1.2 Formulation, Appearance, Packaging and Labeling ................................................................................. 24 6.1.3 Product Storage and Stability .................................................................................................................. 24 3 Protocol Number: MAP-7189 Version 1.3; 28 December 2017 6.1.4 Preparation ............................................................................................................................................. 24 6.1.5 Dosing and Administration ...................................................................................................................... 25 6.1.6 Route of Administration ........................................................................................................................... 25 6.1.7 Blinding .................................................................................................................................................. 25 6.1.8 Duration of Therapy ................................................................................................................................ 25 6.1.9 Tracking of Dose and Treatment Compliance .......................................................................................... 26 6.2 Study Drug Accountability ........................................................................................................................... 26 7 Study Procedures and Schedule of Events ...................................................................................................... 26 7.1 Study Procedures/Evaluations .................................................................................................................... 26 7.1.1 Study Specific Procedures ...................................................................................................................... 27 7.2 Laboratory Procedures/Evaluations ............................................................................................................. 27 7.2.1 Clinical Laboratory Evaluations ............................................................................................................... 27 7.3 Study Schedule........................................................................................................................................... 27 7.3.1 Screening ............................................................................................................................................... 27 7.3.2 Enrollment/Baseline ..................................................................................................................... 28 7.3.3 Follow-up ................................................................................................................................................ 28 7.3.4 Final Study Visit ...................................................................................................................................... 29 7.3.5 Unscheduled Visit ................................................................................................................................... 29 7.3.6 Rescreening ........................................................................................................................................... 29 7.4 Concomitant Medications, Treatments, and Procedures .............................................................................. 29 7.4.1 Precautionary Medications, Treatments, and Procedures ........................................................................ 30 7.5 Prohibited Medications, Treatments, and Procedures .................................................................................. 30 7.6 Rescue Medications, Treatments, and Procedures................................................................................. 30 7.7 Participant Access to Study Drug at Study Center .................................................................................
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