Treatment of Androgenetic Alopecia in Males

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00947505
Recruitment Status : Completed
First Posted : July 28, 2009
Results First Posted : July 30, 2012
Last Update Posted : July 30, 2012
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

  Participant Flow

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

Reporting Groups
LLT Device 2009 7 Beam No text entered.
Control Device No text entered.

Participant Flow:   Overall Study
    LLT Device 2009 7 Beam   Control Device
STARTED   33   16 
COMPLETED   24   14 

  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
LLT Device 2009 7 Beam No text entered.
Control Device No text entered.
Total Total of all reporting groups

Baseline Measures
   LLT Device 2009 7 Beam   Control Device   Total 
Overall Participants Analyzed 
[Units: Participants]
 33   16   49 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   33   16   49 
>=65 years   0   0   0 
[Units: Participants]
Female   0   0   0 
Male   33   16   49 

  Outcome Measures

1.  Primary:   Changes in Terminal Hair Count at 16 and 26 Weeks Over Baseline   [ Time Frame: 16 and 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
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  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: 561-417-0200


Responsible Party: Lexington International, LLC 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