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Trial record 20 of 109 for:    "androgenetic alopecia" OR "female pattern baldness" OR "male pattern baldness"

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
Enrollment 72
Recruitment Details 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 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 HairMax LaserComb 2009 9 Beam Control Device
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 48 24
Completed 43 22
Not Completed 5 2
Reason Not Completed
Lost to Follow-up             5             2
Arm/Group Title HairMax LaserComb 2009 9 Beam Control Device Total
Hide Arm/Group Description 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 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 of all reporting groups
Overall Number of Baseline Participants 43 22 65
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants 22 participants 65 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
43
 100.0%
22
 100.0%
65
 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 43 participants 22 participants 65 participants
Female
43
 100.0%
22
 100.0%
65
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Changes in Terminal Hair Count Week 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 Control Device HairMax LaserComb 2009 9 Beam
Hide Arm/Group Description:
This control device is inactive emitting white light
This device is the active device with 9 laser modules
Overall Number of Participants Analyzed 22 43
Mean (Standard Deviation)
Unit of Measure: hairs per cm^2
Change at 16 weeks 1.3  (14.67) 14.8  (9.70)
Change at 26 weeks 2.8  (16.48) 20.2  (11.15)
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Control Device HairMax LaserComb 2009 9 Beam
Hide Arm/Group Description This control device is inactive emitting white light This device is the active device with 9 laser modules
All-Cause Mortality
Control Device HairMax LaserComb 2009 9 Beam
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Control Device HairMax LaserComb 2009 9 Beam
Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)   0/43 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Control Device HairMax LaserComb 2009 9 Beam
Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)   0/43 (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: 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