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Study of the Effect of Low Level Laser Light on Hair Growth on the Female Human Scalp

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.
 
ClinicalTrials.gov Identifier: NCT01292746
Recruitment Status : Terminated (Recruitment and subject study compliance was difficult)
First Posted : February 9, 2011
Results First Posted : December 11, 2015
Last Update Posted : December 11, 2015
Sponsor:
Information provided by (Responsible Party):
Erchonia Corporation

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Female Pattern Alopecia
Intervention Device: Erchonia MLS
Enrollment 14
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Erchonia MLS
Hide Arm/Group Description Erchonia MLS employs four diodes emitting 10 milliwatts (mW) 635 nanometer (nm) red laser light.
Period Title: Overall Study
Started 14
Completed 14
Not Completed 0
Arm/Group Title Erchonia MLS
Hide Arm/Group Description The Erchonia MLS administers 4 diodes of 10 milliwatts (mW) 635 nanometers (nm) red light to the scalp area for 18 minutes, 2 times each week for 12 consecutive weeks for a total of 24 treatments.
Overall Number of Baseline Participants 14
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
<=18 years
0
   0.0%
Between 18 and 65 years
14
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
Female
14
 100.0%
Male
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
14
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 14 participants
14
Non-Vellus Terminal Hair Count   [1] 
Mean (Standard Deviation)
Unit of measure:  Hairs/cm2
Number Analyzed 14 participants
171.57  (60.78)
[1]
Measure Description: Non-vellus terminal hair count per centimeter squared (cm2) was calculated by independent evaluator analysis employing digital photograph images and macroimage analysis software
1.Primary Outcome
Title Change in Non-vellus Terminal Hair Count Across a 3 cm Diameter Scalp Area
Hide Description Non-vellus terminal hair count was calculated across a tattooed 3 cm diameter scalp area from digital photographs of the area by independent blinded evaluator employing macroimage analysis software.
Time Frame Baseline and 13 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Erchonia MLS
Hide Arm/Group Description:
Erchonia MLS: The Erchonia MLS administers 4 diodes of 10 milliwatts (mW) 635 nanometers (nm) red light to the scalp area for 18 minutes, 2 times each week for 12 consecutive weeks for a total of 24 treatments.
Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: hairs/cm2
10.93  (13.90)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Erchonia MLS
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments 2 sided t-test for correlated samples.
Time Frame 13 Weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Erchonia MLS
Hide Arm/Group Description The Erchonia MLS administers 4 diodes of 10 milliwatts (mW) 635 nanometers (nm) red light to the scalp area for 18 minutes, 2 times each week for 12 consecutive weeks for a total of 24 treatments.
All-Cause Mortality
Erchonia MLS
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Erchonia MLS
Affected / at Risk (%)
Total   0/14 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Erchonia MLS
Affected / at Risk (%)
Total   0/14 (0.00%) 
[Not Specified]
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
Layout table for Results Point of Contact information
Name/Title: Clinical Consultant
Organization: Regulatory Insight, Inc.
Phone: 615-712-9743
EMail: elvira@reginsight.com
Layout table for additonal information
Responsible Party: Erchonia Corporation
ClinicalTrials.gov Identifier: NCT01292746    
Other Study ID Numbers: EC_FA001
First Submitted: February 8, 2011
First Posted: February 9, 2011
Results First Submitted: July 9, 2015
Results First Posted: December 11, 2015
Last Update Posted: December 11, 2015