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Treatment of Androgenetic Alopecia in Males

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ClinicalTrials.gov Identifier: NCT00947505
Recruitment Status : Completed
First Posted : July 28, 2009
Results First Posted : July 30, 2012
Last Update Posted : July 30, 2012
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 2009, 7 Beam
Device: HairMax LaserComb
Enrollment 49
Recruitment Details 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 Norwood Hamilton Classifications of IIa-V, have active hair loss with the last 12 months
Pre-assignment Details Exclusion Criteria: Individuals with photosensitivity to laser light, histor of any malignancy in target area. Also, use of phytotherapy (e.g. saw palmetto) within 8 weeks prior to baseline and use of retinoids in past year, chronic dermatological condtion (eczema , psoriasis, infection, etc.) of the scalp other than male pattern baldness
Arm/Group Title LLT Device 2009 7 Beam Control Device
Hide Arm/Group Description [Not Specified] [Not Specified]
Period Title: Overall Study
Started 33 16
Completed 24 14
Not Completed 9 2
Arm/Group Title LLT Device 2009 7 Beam Control Device Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 33 16 49
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 16 participants 49 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
33
 100.0%
16
 100.0%
49
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 16 participants 49 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
33
 100.0%
16
 100.0%
49
 100.0%
1.Primary Outcome
Title Changes in Terminal Hair Count at 16 and 26 Weeks Over Baseline
Hide Description Results of terminal hair count will be compared to baseline for each user between active and control devicea at 26 weeks with an interim evaluation at week 16. Terminal hair count, which is non-vellus/non-miniaturized hair counts, will be assessed in the target region
Time Frame 16 and 26 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title LLT Device 2009 7 Beam Control Device
Hide Arm/Group Description:
This is the active LLLT device
This is the control device emitting white light
Overall Number of Participants Analyzed 24 14
Mean (Standard Deviation)
Unit of Measure: change in terminal hair count
Change at 16 weeks 17.7  (12.83) 2.8  (6.89)
Change at 26 weeks 18.4  (16.6) 1.6  (8.60)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title LLT Device 2009 7 Beam Control Device
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
LLT Device 2009 7 Beam Control Device
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
LLT Device 2009 7 Beam Control Device
Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)   0/14 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
LLT Device 2009 7 Beam Control Device
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
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: NCT00947505     History of Changes
Other Study ID Numbers: 7 2009-M-01
First Submitted: July 27, 2009
First Posted: July 28, 2009
Results First Submitted: January 6, 2011
Results First Posted: July 30, 2012
Last Update Posted: July 30, 2012