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The purpose of this study is to evaluate the efficacy of the HairMax LaserComb 2009 12 beam model for androgenetic alopecia in females when treatment is applied as directed.
This is a randomized double-blind, sham controlled clinical study, evaluating changes in terminal hair count in the evaluation zone having evidence of androgenetic alopecia (miniaturized hair).
The trial with 60 female subjects, who have been diagnosed with androgenetic alopecia, who are between 25 and 60 years of age, have Fitzpatrick Skin Types I-IV, with classifications of Ludwig I-4, II-1, II-2, or frontal, have active hair loss within the last 12 months.
Subjects will use the device on three non-concurring days a week as directed per device for 26 weeks duration.
Initial efficacy endpoint for each subject will be assessed at visit 4 (week 16).
Safety analysis will be assessed based on the reports of adverse events during study.
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
HairMax LaserComb 2009 model 12 beam, Sham Device
University of Miami Miller School of Medicine - Dermatology
Lexington International, LLC
Published on BioPortfolio: 2014-08-27T03:17:50-0400
The purpose of this study is to evaluate the efficacy of the HairMax LaserComb 2009 9 beam model in promoting hair growth in females diagnosed with androgenetic alopecia when treatment is ...
The purpose of this study is to evaluate the efficacy of the HairMax LaserComb 2009 7 Beam model in promoting hair growth in men diagnosed with androgenetic alopecia when treatment is appl...
The purpose of this study is to evaluate the efficacy of the HairMax LaserComb 2009 9 & 12 Beam models in promoting hair growth in men diagnosed with androgenetic alopecia when treatment i...
HairMax 12 2009-F-02 is a double blind study to evaluate the treatment of androgenetic alopecia.
The purpose of this study is to test whether the stimulation of vascularization and cellular metabolism on the scalp by use of the HairMax LaserComb will produce improvement in the conditi...
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The science and application of a double-beam transmission interference microscope in which the illuminating light beam is split into two paths. One beam passes through the specimen while the other beam reflects off a reference mirror before joining and interfering with the other. The observed optical path difference between the two beams can be measured and used to discriminate minute differences in thickness and refraction of non-stained transparent specimens, such as living cells in culture.
A novel composition, device, or process, independently conceived de novo or derived from a pre-existing model.
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Statistical formulations or analyses which, when applied to data and found to fit the data, are then used to verify the assumptions and parameters used in the analysis. Examples of statistical models are the linear model, binomial model, polynomial model, two-parameter model, etc.
Removal of a MEDICAL DEVICE from the market due to the identification of an intrinsic property of the device that results in a serious risk to public health.
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