Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Treatment of Androgenic Alopecia in Males

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lexington International, LLC
ClinicalTrials.gov Identifier:
NCT00947219
First received: July 27, 2009
Last updated: December 21, 2012
Last verified: December 2012
Results First Received: January 6, 2011  
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
Male Pattern Baldness
Interventions: Device: HairMax LaserComb
Device: Control device

  Participant Flow
  Hide 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 alopicia, who are between 25 and 60 years of age, have Fitzpatrick Skin Types i-IV and Norwood Hamilton Classifications of IIa to IV and 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, history of any malignancy in target area, has used phytotherapy (e.g. saw palmetto) with 8 weeks prior to baseline. Subjects who has chronic dermatological conditions (eczema, psoriasis, etc) of the scalp other than male pattern baldness

Reporting Groups
  Description
HairMax LaserComb 2009, 12 Beam LLLT Device 2009 12 Beam, Control Device
HairMax LaserComb 2009 9 Beam LLLT Device 2009 9 Beam, Control Device
Control Device Control device emitting LED light

Participant Flow:   Overall Study
    HairMax LaserComb 2009, 12 Beam     HairMax LaserComb 2009 9 Beam     Control Device  
STARTED     28     25     26  
COMPLETED     22     21     22  
NOT COMPLETED     6     4     4  



  Baseline Characteristics
  Hide 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, 12 Beam LLLT Device 2009 12 Beam, Control Device
HairMax LaserComb 2009 9 Beam LLLT Device 2009 9 Beam, Control Device
Control Device Control device emitting LED light
Total Total of all reporting groups

Baseline Measures
    HairMax LaserComb 2009, 12 Beam     HairMax LaserComb 2009 9 Beam     Control Device     Total  
Number of Participants  
[units: participants]
  28     25     26     79  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     28     25     26     79  
>=65 years     0     0     0     0  
Gender  
[units: participants]
       
Female     0     0     0     0  
Male     28     25     26     79  



  Outcome Measures

1.  Primary:   Changes in Terminal Hair Count at 16 and 26 Weeks Compared to Baseline in Men Diagnosed With Androgenetic Alopecia   [ Time Frame: baseline, 16 and 26 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
  Hide 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
e-mail: dm@hairmax.com


Publications:

Responsible Party: Lexington International, LLC
ClinicalTrials.gov Identifier: NCT00947219     History of Changes
Other Study ID Numbers: 9.12 2009-M-02
Study First Received: July 27, 2009
Results First Received: January 6, 2011
Last Updated: December 21, 2012
Health Authority: United States: Institutional Review Board