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A Novel Approach to Treating Androgenetic Alopecia in Females With Low Level Laser Therapy

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ClinicalTrials.gov Identifier: NCT01967277
Recruitment Status : Completed
First Posted : October 22, 2013
Results First Posted : May 6, 2015
Last Update Posted : May 6, 2015
Sponsor:
Information provided by (Responsible Party):
Capillus, LLC

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Androgenetic Alopecia
Interventions: Device: Handi-Dome Laser
Device: Incandescent red light source.

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Incandescent Red Light Source

Placebo: A red, incandescent light source replaces all laser output. The treatment sessions are self-administered at home, every other day, for 16 weeks.

Incandescent red light source.: One, 30 minute treatment, every other day for 16 weeks.

Handi-Dome Laser

Active Device: Study subjects self-administer actual laser treatments, at home, every other day, for 16 weeks.

Handi-Dome Laser: One, 30 minute treatment, every other day for 16 weeks.


Participant Flow:   Overall Study
    Incandescent Red Light Source   Handi-Dome Laser
STARTED   22   22 
COMPLETED   21   19 
NOT COMPLETED   1   3 
Lost to Follow-up                1                2 
Unrelated illness                0                1 



  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
Incandescent Red Light Source

Placebo: A red, incandescent light source replaces all laser output. The treatment sessions are self-administered at home, every other day, for 16 weeks.

Incandescent red light source.: One, 30 minute treatment, every other day for 16 weeks.

Handi-Dome Laser

Active Device: Study subjects self-administer actual laser treatments, at home, every other day, for 16 weeks.

Handi-Dome Laser: One, 30 minute treatment, every other day for 16 weeks.

Total Total of all reporting groups

Baseline Measures
   Incandescent Red Light Source   Handi-Dome Laser   Total 
Overall Participants Analyzed 
[Units: Participants]
 22   22   44 
Age 
[Units: Years]
Median (Full Range)
 49 
 (28 to 60) 
 49.5 
 (28 to 58) 
 49 
 (28 to 60) 
Gender 
[Units: Participants]
     
Female   22   22   44 
Male   0   0   0 
Region of Enrollment 
[Units: Participants]
     
United States   22   22   44 


  Outcome Measures

1.  Primary:   Percentage Increase in Terminal Hair Counts From Pre-Treatment, Baseline for Active Test Subjects Over the Placebo Test Subjects.   [ Time Frame: baseline and 17 weeks ]

Measure Type Primary
Measure Title Percentage Increase in Terminal Hair Counts From Pre-Treatment, Baseline for Active Test Subjects Over the Placebo Test Subjects.
Measure Description At baseline, a 25 mm area of treatment was trimmed of hair (to 3mm) at the vertex of the scalp and photographs were taken, terminal hairs were counted.
Time Frame baseline and 17 weeks  

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
Incandescent Red Light Source

Placebo: A red, incandescent light source replaces all laser output. The treatment sessions are self-administered at home, every other day, for 16 weeks.

Incandescent red light source.: One, 30 minute treatment, every other day for 16 weeks.

Handi-Dome Laser

Active Device: Study subjects self-administer actual laser treatments, at home, every other day, for 16 weeks.

Handi-Dome Laser: One, 30 minute treatment, every other day for 16 weeks.


Measured Values
   Incandescent Red Light Source   Handi-Dome Laser 
Participants Analyzed   21   19 
Percentage Increase in Terminal Hair Counts From Pre-Treatment, Baseline for Active Test Subjects Over the Placebo Test Subjects. 
[Units: Percent change]
Mean (Standard Deviation)
 12.48  (13.76)   63.67  (50.9) 


Statistical Analysis 1 for Percentage Increase in Terminal Hair Counts From Pre-Treatment, Baseline for Active Test Subjects Over the Placebo Test Subjects.
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] t-test, 2 sided
P Value [4] <0.001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  H0: µL ≤ µs Versus Ha: µL > µs
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



2.  Primary:   Absolute Increase in Terminal Hair Counts From Pre-Treatment, Baseline for Active Test Subjects Over the Placebo Test Subjects.   [ Time Frame: baseline and 17 weeks ]

Measure Type Primary
Measure Title Absolute Increase in Terminal Hair Counts From Pre-Treatment, Baseline for Active Test Subjects Over the Placebo Test Subjects.
Measure Description At baseline, a 25 mm area of treatment was trimmed of hair (to 3mm) at the vertex of the scalp and photographs were taken, terminal hairs were counted.
Time Frame baseline and 17 weeks  

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
Incandescent Red Light Source

Placebo: A red, incandescent light source replaces all laser output. The treatment sessions are self-administered at home, every other day, for 16 weeks.

Incandescent red light source.: One, 30 minute treatment, every other day for 16 weeks.

Handi-Dome Laser

Active Device: Study subjects self-administer actual laser treatments, at home, every other day, for 16 weeks.

Handi-Dome Laser: One, 30 minute treatment, every other day for 16 weeks.


Measured Values
   Incandescent Red Light Source   Handi-Dome Laser 
Participants Analyzed   21   19 
Absolute Increase in Terminal Hair Counts From Pre-Treatment, Baseline for Active Test Subjects Over the Placebo Test Subjects. 
[Units: Terminal hairs]
Mean (Standard Deviation)
   
Hair count, baseline   216.9  (109.1)   189.3  (85.8) 
Hair count, post treatment   235.3  (105.8)   268.3  (117.7) 
Hair count, difference   18.5  (24.4)   89.9  (63.3) 

No statistical analysis provided for Absolute Increase in Terminal Hair Counts From Pre-Treatment, Baseline for Active Test Subjects Over the Placebo Test Subjects.




  Serious Adverse Events

Time Frame No text entered.
Additional Description No text entered.

Reporting Groups
  Description
Incandescent Red Light Source

Placebo: A red, incandescent light source replaces all laser output. The treatment sessions are self-administered at home, every other day, for 16 weeks.

Incandescent red light source.: One, 30 minute treatment, every other day for 16 weeks.

Handi-Dome Laser

Active Device: Study subjects self-administer actual laser treatments, at home, every other day, for 16 weeks.

Handi-Dome Laser: One, 30 minute treatment, every other day for 16 weeks.


Serious Adverse Events
    Incandescent Red Light Source   Handi-Dome Laser
Total, Serious Adverse Events     
# participants affected / at risk   0/22 (0.00%)   0/22 (0.00%) 




  Other Adverse Events

Time Frame No text entered.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   0%  

Reporting Groups
  Description
Incandescent Red Light Source

Placebo: A red, incandescent light source replaces all laser output. The treatment sessions are self-administered at home, every other day, for 16 weeks.

Incandescent red light source.: One, 30 minute treatment, every other day for 16 weeks.

Handi-Dome Laser

Active Device: Study subjects self-administer actual laser treatments, at home, every other day, for 16 weeks.

Handi-Dome Laser: One, 30 minute treatment, every other day for 16 weeks.


Other Adverse Events
    Incandescent Red Light Source   Handi-Dome Laser
Total, Other (not including serious) Adverse Events     
# participants affected / at risk   0/22 (0.00%)   0/22 (0.00%) 



  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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Patricia Schnoor
Organization: Capillus LLC
phone: 7868881874
e-mail: pschnoor@capillus.com



Responsible Party: Capillus, LLC
ClinicalTrials.gov Identifier: NCT01967277     History of Changes
Other Study ID Numbers: USC650
First Submitted: October 18, 2013
First Posted: October 22, 2013
Results First Submitted: May 5, 2015
Results First Posted: May 6, 2015
Last Update Posted: May 6, 2015