Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-25 @ 3:26 AM
NCT ID:
NCT00947505
Brief Summary:
The purpose of this study is to evaluate the efficacy of the HairMax LaserComb 2009 7 Beam model in promoting hair growth in males diagnosed with androgenetic alopecia when treatment is applied as directed.
Detailed Description:
This is randomized, double-blind, control device clinical study across 2 sites, evaluating changes in terminal hair-count in the evaluation zone having evidence of androgenetic alopecia (miniaturized hair).
The trial will involve 45 male 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 Norwood-Hamilton IIa to V, have active hair loss within the last 12 months.
Subjects will use the device on three nonconcurring days a week as directed per device for 26 weeks treatment 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.
Study:
NCT00947505
Study Brief:
Protocol Section:
NCT00947505