Ignite Creation Date:
2025-12-24 @ 12:17 PM
Ignite Modification Date:
2025-12-27 @ 10:05 PM
Study NCT ID:
NCT00981461
Status:
COMPLETED
Last Update Posted:
2012-08-10
First Post:
2009-09-21
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Treatment of Androgenetic Alopecia in Females, 9 Beam
Sponsor:
Lexington International, LLC
Organization:
Study Overview
Official Title:
A Randomized, Double-Blind Clinical Trial to Evaluate the Safety and Efficacy of the HairMax LaserComb 2009, 9 Beam Model: For the Treatment of Androgenetic Alopecia in Females
Status:
COMPLETED
Status Verified Date:
2012-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 applied as directed.
Detailed Description:
This is a randomized double-blind, control device clinical study across 5 sites, 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 assess at visit 4 (week 16).
Safety analysis will be assessed based on the reports of adverse events during study.
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 assess at visit 4 (week 16).
Safety analysis will be assessed based on the reports of adverse events during study.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: