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Treatment of Androgenetic Alopecia in Females, 12 Beam

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ClinicalTrials.gov Identifier: NCT01016964
Recruitment Status : Completed
First Posted : November 20, 2009
Results First Posted : September 7, 2012
Last Update Posted : September 7, 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
Female Pattern Baldness
Interventions Device: HairMax LaserComb 2009 model 12 beam
Device: Sham Device
Enrollment 63
Recruitment Details This double-blind, device controlled 26 week study was recruited at 3 clinical study sites. The recruitment period was from February 1, 2010 to September 28, 2010
Pre-assignment Details Key exclusion criteria was pregnancy, malignancy in target area, an no hair transplants, scalp reductions, or hair weaves. Active hair loss less than 12 months.
Arm/Group Title Sham Device LLT Device 2009 12 Beams
Hide Arm/Group Description Sham device HairMax LaserComb 2009 model 12 beam
Period Title: Overall Study
Started 21 42
Completed 18 39
Not Completed 3 3
Reason Not Completed
Lost to Follow-up             3             3
Arm/Group Title Sham Device LLT Device 2009 12 Beams Total
Hide Arm/Group Description Sham device HairMax LaserComb 2009 model 12 beam Total of all reporting groups
Overall Number of Baseline Participants 21 42 63
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 42 participants 63 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
21
 100.0%
42
 100.0%
63
 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 21 participants 42 participants 63 participants
Female
21
 100.0%
42
 100.0%
63
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Change in Hair Count at 16 and 26 Weeks Over Baseline
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 weeks, 26 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sham Device LLT Device 2009 12 Beams
Hide Arm/Group Description:
This control device emits white light
This is the active LLLT device
Overall Number of Participants Analyzed 18 39
Mean (Standard Deviation)
Unit of Measure: hairs per cm^2
Change at 16 weeks -0.8  (7.87) 12.5  (11.35)
Change at 26 weeks 3.0  (9.33) 20.6  (11.55)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sham Device LLT Device 2009 12 Beams
Hide Arm/Group Description Sham device HairMax LaserComb 2009 model 12 beam
All-Cause Mortality
Sham Device LLT Device 2009 12 Beams
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Sham Device LLT Device 2009 12 Beams
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/39 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Sham Device LLT Device 2009 12 Beams
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/39 (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: 5614170200
Responsible Party: Lexington International, LLC
ClinicalTrials.gov Identifier: NCT01016964     History of Changes
Obsolete Identifiers: NCT01042756
Other Study ID Numbers: 12 2009-F-02
First Submitted: November 18, 2009
First Posted: November 20, 2009
Results First Submitted: June 25, 2012
Results First Posted: September 7, 2012
Last Update Posted: September 7, 2012