Treatment of Androgenic Alopecia in Males
A Randomized, Double-Blind, Control Device Clinical Trial to Evaluate the Safety and Efficacy of the HairMax LaserComb 2009, 9 & 12 Beam Models: For the Treatment of Androgenetic Alopecia in Males
Sponsor: Lexington International, LLC
Listed as NCT00947219, this NA trial focuses on Androgenetic Alopecia and Hair Loss and remains completed. Sponsored by Lexington International, LLC, it has been updated 8 times since 2009, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.
Study Description(click to expand)This is randomized, double-blind, control device clinical study across 3 sites, evaluating changes in terminal hair-count in the evaluation zone having evidence of androgenetic alopecia (miniaturized hair).
The trial will involve approximately 75 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 non-consecutive days a week as directed per device for 26 weeks treatment duration.
Safety analysis will be assessed based on the reports of adverse events during study.
This is randomized, double-blind, control device clinical study across 3 sites, evaluating changes in terminal hair-count in the evaluation zone having evidence of androgenetic alopecia (miniaturized hair).
The trial will involve approximately 75 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 non-consecutive days a week as directed per device for 26 weeks treatment duration.
Safety analysis will be assessed based on the reports of adverse events during study.
Status Flow
Change History
8 versions recorded-
Sep 2024 — Present [monthly]
Completed NA
-
Jul 2024 — Sep 2024 [monthly]
Completed NA
-
Jan 2023 — Jul 2024 [monthly]
Completed NA
-
Dec 2022 — Jan 2023 [monthly]
Completed NA
-
Jan 2021 — Dec 2022 [monthly]
Completed NA
▶ Show 3 earlier versions
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Jun 2018 — Jan 2021 [monthly]
Completed NA
-
Feb 2017 — Jun 2018 [monthly]
Completed NA
-
Jan 2017 — Feb 2017 [monthly]
Completed NA
First recorded
Jul 2009
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Lexington International, LLC
For direct contact, visit the study record on ClinicalTrials.gov .