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Treatment of Androgenic Alopecia in Males

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ClinicalTrials.gov Identifier: NCT00947219
Recruitment Status : Completed
First Posted : July 28, 2009
Results First Posted : January 31, 2013
Last Update Posted : January 31, 2013
Sponsor:
Information provided by (Responsible Party):
Lexington International, LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Androgenetic Alopecia
Hair Loss
Male Pattern Baldness
Interventions Device: HairMax LaserComb
Device: Control device
Enrollment 79
Recruitment Details Male subjects who have been diagnosed with androgenetic alopicia, who are between 25 and 60 years of age, have Fitzpatrick Skin Types i-IV and Norwood Hamilton Classifications of IIa to IV and have active hair loss with the last 12 months
Pre-assignment Details Exclusion criteria: Individuals with photosensitivity to laser light, history of any malignancy in target area, has used phytotherapy (e.g. saw palmetto) with 8 weeks prior to baseline. Subjects who has chronic dermatological conditions (eczema, psoriasis, etc) of the scalp other than male pattern baldness
Arm/Group Title HairMax LaserComb 2009, 12 Beam HairMax LaserComb 2009 9 Beam Control Device
Hide Arm/Group Description LLLT Device 2009 12 Beam, Control Device LLLT Device 2009 9 Beam, Control Device Control device emitting LED light
Period Title: Overall Study
Started 28 25 26
Completed 22 21 22
Not Completed 6 4 4
Arm/Group Title HairMax LaserComb 2009, 12 Beam HairMax LaserComb 2009 9 Beam Control Device Total
Hide Arm/Group Description LLLT Device 2009 12 Beam, Control Device LLLT Device 2009 9 Beam, Control Device Control device emitting LED light Total of all reporting groups
Overall Number of Baseline Participants 28 25 26 79
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 25 participants 26 participants 79 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
28
 100.0%
25
 100.0%
26
 100.0%
79
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 25 participants 26 participants 79 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
28
 100.0%
25
 100.0%
26
 100.0%
79
 100.0%
1.Primary Outcome
Title Changes in Terminal Hair Count at 16 and 26 Weeks Compared to Baseline in Men Diagnosed With Androgenetic Alopecia
Hide Description The primary analysis of effectiveness was an analysis of covariance, which separately modeled terminal hair count at Week 16 and Week 26 as a function of treatment group (HairMax LaserComb 2009 9 Beam vs.control), study center, age (as a continuous variable), and Fitzpatrick Skin Type classification (as a categorical variable with four levels). The active group was compared to the control device using least squares means with a two-sided test at the 5% level of significance.
Time Frame baseline, 16 and 26 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HairMax LaserComb 2009, 12 Beam HairMax LaserComb 2009 9 Beam Control Device
Hide Arm/Group Description:
The active LLLT Device 2009 with 12 laser modules
the active LLLT Device 2009 9 laser modules
Control device emitting white light
Overall Number of Participants Analyzed 22 21 22
Overall Number of Units Analyzed
Type of Units Analyzed: Hairs per cm^2
22 21 22
Mean (Standard Deviation)
Unit of Measure: hairs per cm^2
Change at 16 weeks 23.5  (17.67) 20.4  (14.52) 4.4  (8.38)
Change at 26 weeks 25.7  (16.92) 20.9  (14.08) 9.4  (12.94)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title HairMax LaserComb 2009, 12 Beam HairMax LaserComb 2009 9 Beam Control Device
Hide Arm/Group Description LLLT Device 2009 12 Beam, Control Device LLLT Device 2009 9 Beam, Control Device Control device emitting LED light
All-Cause Mortality
HairMax LaserComb 2009, 12 Beam HairMax LaserComb 2009 9 Beam Control Device
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
HairMax LaserComb 2009, 12 Beam HairMax LaserComb 2009 9 Beam Control Device
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/28 (0.00%)   0/25 (0.00%)   0/26 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
HairMax LaserComb 2009, 12 Beam HairMax LaserComb 2009 9 Beam Control Device
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/28 (0.00%)   0/25 (0.00%)   0/26 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: David Michaels
Organization: Lexington International, LLC
Phone: 561-417-0200
Responsible Party: Lexington International, LLC
ClinicalTrials.gov Identifier: NCT00947219     History of Changes
Other Study ID Numbers: 9.12 2009-M-02
First Submitted: July 27, 2009
First Posted: July 28, 2009
Results First Submitted: January 6, 2011
Results First Posted: January 31, 2013
Last Update Posted: January 31, 2013