A Study Evaluating the Efficacy and Safety of SM04554 Topical Solution in Male Subjects With Androgenetic Alopecia
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03742518 |
Recruitment Status :
Completed
First Posted : November 15, 2018
Last Update Posted : December 28, 2021
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Sponsor:
Biosplice Therapeutics, Inc.
Information provided by (Responsible Party):
Biosplice Therapeutics, Inc.
Tracking Information | |||||
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First Submitted Date ICMJE | November 13, 2018 | ||||
First Posted Date ICMJE | November 15, 2018 | ||||
Last Update Posted Date | December 28, 2021 | ||||
Actual Study Start Date ICMJE | November 1, 2018 | ||||
Actual Primary Completion Date | December 31, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Absolute non-vellus hair count in target area [ Time Frame: Week 48 ] Absolute non-vellus hair count in target area by phototrichogram (PTG) analysis
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | A Study Evaluating the Efficacy and Safety of SM04554 Topical Solution in Male Subjects With Androgenetic Alopecia | ||||
Official Title ICMJE | Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of 0.15% & 0.25% Concentrations of Topical SM04554 Solution in Male Subjects With Androgenetic Alopecia | ||||
Brief Summary | This multi-center, randomized, double-blind, placebo-controlled study, conducted in Turkey, will assess the efficacy and safety of topical SM04554 solution (0.15% and 0.25%) applied daily to the scalp of male androgenetic alopecia (AGA) subjects. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 Phase 3 |
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Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Androgenetic Alopecia | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
675 | ||||
Original Estimated Enrollment ICMJE |
625 | ||||
Actual Study Completion Date ICMJE | December 31, 2020 | ||||
Actual Primary Completion Date | December 31, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 45 Years (Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Turkey | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03742518 | ||||
Other Study ID Numbers ICMJE | SM04554-AGA-05 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Current Responsible Party | Biosplice Therapeutics, Inc. | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Biosplice Therapeutics, Inc. | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Biosplice Therapeutics, Inc. | ||||
Verification Date | December 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |