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Treatment of Androgenetic Alopecia in Females, 9 Beam

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ClinicalTrials.gov Identifier: NCT00981461
Recruitment Status : Completed
First Posted : September 22, 2009
Results First Posted : July 30, 2012
Last Update Posted : August 10, 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
Device: Control Device

  Participant Flow

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 6 clinical study sites. The recruitment period was from October 29, 2008 to March 2, 2009

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
  Description
HairMax LaserComb 2009 9 Beam This arm involves the active LLLT device with 9 laser modules. The device is used 3 times a week for 12 minutes per session for full 26 duration of the study. This device was distributed to subjects in a blinded randomized manner. Subjects were evaluated at 8, 16 and 26 weeks, with hair counts performed at week 16 and 26.
Control Device This arm involves the use of an inactive control device that emits white light. The device is used 3 times a week for full 26 duration of study. This arm of the study was blinded and dispensed to subjects on a random basis.Subjects were evaluated at 8, 16 and 26 weeks, with hair counts performed at week 16 and 26.

Participant Flow:   Overall Study
    HairMax LaserComb 2009 9 Beam   Control Device
STARTED   48   24 
COMPLETED   43   22 
NOT COMPLETED   5   2 
Lost to Follow-up                5                2 



  Baseline Characteristics

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.
No text entered.

Reporting Groups
  Description
HairMax LaserComb 2009 9 Beam This arm involves the active LLLT device with 9 laser modules. The device is used 3 times a week for 12 minutes per session for full length of study. This device was distributed to subjects in a blinded randomized manner
Control Device This arm involves the use of an inactive control device that emits white light. The device is used 3 times a week for full length of study. This arm of the study was blinded and dispensed to subjects on a random basis.
Total Total of all reporting groups

Baseline Measures
   HairMax LaserComb 2009 9 Beam   Control Device   Total 
Overall Participants Analyzed 
[Units: Participants]
 43   22   65 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   43   22   65 
>=65 years   0   0   0 
Gender 
[Units: Participants]
     
Female   43   22   65 
Male   0   0   0 


  Outcome Measures

1.  Primary:   Changes in Terminal Hair Count Week 16 and 26 Weeks Over Baseline   [ Time Frame: Baseline, 16 weeks, 26 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

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
e-mail: dm@hairmax.com


Publications of Results:

Responsible Party: Lexington International, LLC
ClinicalTrials.gov Identifier: NCT00981461     History of Changes
Other Study ID Numbers: 151.0805
First Submitted: September 21, 2009
First Posted: September 22, 2009
Results First Submitted: April 12, 2012
Results First Posted: July 30, 2012
Last Update Posted: August 10, 2012