Treatment of Androgenetic Alopecia in Females, 12 Beam

This study has been completed.
Information provided by (Responsible Party):
Lexington International, LLC Identifier:
First received: November 18, 2009
Last updated: August 7, 2012
Last verified: August 2012
Results First Received: June 25, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, 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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
Sham Device Sham device
LLT Device 2009 12 Beams HairMax LaserComb 2009 model 12 beam

Participant Flow:   Overall Study
    Sham Device     LLT Device 2009 12 Beams  
STARTED     21     42  
COMPLETED     18     39  
NOT COMPLETED     3     3  
Lost to Follow-up                 3                 3  

  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
Sham Device Sham device
LLT Device 2009 12 Beams HairMax LaserComb 2009 model 12 beam
Total Total of all reporting groups

Baseline Measures
    Sham Device     LLT Device 2009 12 Beams     Total  
Number of Participants  
[units: participants]
  21     42     63  
[units: participants]
<=18 years     0     0     0  
Between 18 and 65 years     21     42     63  
>=65 years     0     0     0  
[units: Participants]
Female     21     42     63  
Male     0     0     0  

  Outcome Measures

1.  Primary:   Change in Hair Count at 16 and 26 Weeks Over Baseline   [ Time Frame: Baseline, 16 weeks, 26 weeks ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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 Identifier: NCT01016964     History of Changes
Obsolete Identifiers: NCT01042756
Other Study ID Numbers: 12 2009-F-02
Study First Received: November 18, 2009
Results First Received: June 25, 2012
Last Updated: August 7, 2012
Health Authority: United States: Institutional Review Board