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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.
Enrollment 44

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Incandescent Red Light Source Handi-Dome Laser
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 22 22
Completed 21 19
Not Completed 1 3
Reason Not Completed
Lost to Follow-up             1             2
Unrelated illness             0             1
Arm/Group Title Incandescent Red Light Source Handi-Dome Laser Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 22 22 44
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 22 participants 22 participants 44 participants
49
(28 to 60)
49.5
(28 to 58)
49
(28 to 60)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 22 participants 44 participants
Female
22
 100.0%
22
 100.0%
44
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 22 participants 22 participants 44 participants
22 22 44
1.Primary Outcome
Title Percentage Increase in Terminal Hair Counts From Pre-Treatment, Baseline for Active Test Subjects Over the Placebo Test Subjects.
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Incandescent Red Light Source Handi-Dome Laser
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 21 19
Mean (Standard Deviation)
Unit of Measure: percent change
12.48  (13.76) 63.67  (50.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Incandescent Red Light Source, Handi-Dome Laser
Comments H0: µL ≤ µs Versus Ha: µL > µs
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Primary Outcome
Title Absolute Increase in Terminal Hair Counts From Pre-Treatment, Baseline for Active Test Subjects Over the Placebo Test Subjects.
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Incandescent Red Light Source Handi-Dome Laser
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 21 19
Mean (Standard Deviation)
Unit of Measure: terminal hairs
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)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Incandescent Red Light Source Handi-Dome Laser
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Incandescent Red Light Source Handi-Dome Laser
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Incandescent Red Light Source Handi-Dome Laser
Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)   0/22 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Incandescent Red Light Source Handi-Dome Laser
Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)   0/22 (0.00%) 
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.
PI may not disclose the results of the trial.
Results Point of Contact
Name/Title: Patricia Schnoor
Organization: Capillus LLC
Phone: 7868881874
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